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`IN THE CIRCUIT COURT OF THE
`ELEVENTH JUDICIAL CIRCUIT IN AND
`FOR MIAMI-DADE COUNTY, FLORIDA
`
`
` CASE NO. 2020-5389-CP-02
`PROBATE DIVISION
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`ADVERSARY PROCEEDING
`CASE NO.: 2020-0977-CP-02
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`IN RE: ESTATE OF
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`GARTH C. REEVES, SR.,
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`Decedent.
`_________________________________
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`GARTH BASIL REEVES,
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`Petitioner,
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`v.
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`OLIVER GROSS, et. al.,
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`Respondents.
` /
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`PETITIONER’S NOTICE OF EXPERT WITNESS DISCLOSURE
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`Petitioner, GARTH BASIL REEVES (“Petitioner”), by and through undersigned counsel
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`and pursuant to this Court’s December 15, 2022 Case Management Order, discloses the following
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`expert witness, who may be called to testify at trial in this case:
`
`Marc E. Agronin, M.D.
`c/o Miami Jewish Health
`5200 NE 2nd Avenue
`Miami, Florida 33137
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`1.
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`Dr. Agronin’s CV is attached hereto as Exhibit “A.”
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`2.
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`Dr. Agronin will testify regarding his review and analysis of Garth C. Reeves, Sr.
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`(“Decedent”)’s medical records. Dr. Agronin could arrive at opinions as to Decedent’s
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`testamentary capacity in the time periods before and after the purported execution of an estate plan
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`by Decedent on October 4, 2019, that could assist the trier of fact.
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`3.
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`Dr. Agronin has been retained as an adult and geriatric psychiatry expert and is
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`being compensated at the hourly rate of $500.00 per hour for his services. Dr. Agronin has
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`experience as an adult and geriatric psychiatry expert and has served as an expert in 15 legal cases
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`over the course of 21 years. Dr. Agronin has testified in deposition and at trial 8 times over the
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`course of 21 years. Dr. Agronin has testified generally for both Plaintiffs and Defendants.
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`Respectfully submitted,
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`KLUGER, KAPLAN, SILVERMAN,
`KATZEN & LEVINE, P.L.
`Attorney for Petitioner, Garth Basil Reeves
`Citigroup Center, 27th Floor
`201 South Biscayne Blvd.
`Miami, Florida 33131
`Telephone:
`(305) 379-9000
`Facsimile:
`(305) 379-3428
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`By: /s/ Bruce A. Katzen
` BRUCE A. KATZEN
`Fla. Bar No. 435627
`bkatzen@klugerkaplan.com
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`CERTIFICATE OF SERVICE
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`I HEREBY CERTIFY that on February 13, 2023 a true and correct copy of the foregoing
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`has been electronically served via the Florida Courts e-filing Portal to all counsel of record.
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`By: /s/ Bruce A. Katzen
` Bruce A. Katzen
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`Exhibit A
`Exhibit A
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`MARC EDWARD AGRONIN,M.D.
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`CURRICULUM VITAE
`
`CurrentTitles
`
`> Senior Vice President for Behavioral Health and Chief Medical Officer for MIND Institute, Miami Jewish Health
`> Affiliate Associate Professor of Psychiatry, Department of Psychiatry and Behavioral Sciences, Miller School of Medicine
`at the University of Miami
`> Affiliate Associate Professor of Neurology, Department of Neurology, Miller School of Medicine at the University of
`Miami
`> Boardcertified in Adult and Geriatric Psychiatry
`
`Personal Data
`
`Work:
`
`Miami Jewish Health, 5200 NE 2nd Avenue, Miami, FL 33137
`Phone: (305) 514-8503 / Fax: (305) 762-1426
`magronin@miamijewishhealth.org / magronin@aol.com
`Email:
`Website: Www.marcagronin.com
`
`Education
`
`1987 B.A.
`
`Harvard University, Cambridge, MA
`Graduated Summa Cum Laude with a degree in psychology and philosophy.
`Inducted into Phi Beta Kappa in June of 1987
`
`1991 M.D. Yale University School of Medicine, New Haven, CT
`
`Postdoctoral Training
`
`Internship/Residency
`
`1991-95
`
`Resident in Adult Psychiatry, McLean Hospital, Harvard Medical School, Belmont, MA
`
`1991 - 92
`
`Intern in Medicine, Mt. Auburn Hospital, Cambridge, MA
`
`1994 -95
`
`Chief Resident, Geriatric Psychiatry Program, McLean Hospital, Belmont, MA
`
`Fellowship
`
`1995-96_Fellowin Geriatric Psychiatry, VA Medical Center, University of MN, Minneapolis, MN
`
`Board Certification
`
`1992 -
`
`Diplomate, National Board of Medical Examiners, No. 406034
`
`1996 -
`
`Board Certified, American Board of Psychiatry and Neurology, No. 42976 *
`
`1998 -
`
`Board Certified for Added Qualifications in Geriatric Psychiatry, No. 2386 *
`
`* Re-certification for both boards completed in 2006/2008 and again in 2016
`
`Marc E. Agronin, MD / Bio and CV 2022/ Page 1
`
`
`
`Current Licensure
`
`1999 -
`
`Florida License Registration No. ME 77672
`
`Academic Appointments
`
`1991-95
`
`1996 - 99
`
`1999 - 07
`
`2007-
`
`2010 -
`
`Clinical Fellow in Psychiatry, Harvard Medical School, Boston, MA
`
`Assistant Professor of Psychiatry, University of MN School of Medicine, Minneapolis, MN
`
`Assistant Professor of Psychiatry, Miller School of Medicine at the University of Miami, Miami, FL
`
`Affiliate Associate Professor of Psychiatry, Miller School of Medicine at the University of Miami,
`Miami, FL
`
`Affiliate Associate Professor of Neurology, Miller School of Medicine at the University of Miami,
`Miami, FL
`
`Professional Experience
`
`1993 - 95
`
`1993 - 95
`
`1994 -95
`
`1996 - 99
`
`1996 - 99
`
`1999 - 09
`
`1999-15
`
`1999 - 00
`
`1999 -01
`
`2002
`
`2003 — 06
`
`2004 - 11
`
`Nursing Home Psychiatric Consultant, Heritage Hospital, Somerville, MA
`
`Consultant in Psychiatry, Tri-City Mental Health and Retardation Center, Everett, MA.
`
`Psychiatric Consultant, Human Sexuality Program, McLean Hospital, Belmont, MA
`
`Staff Psychiatrist, Geropsychiatry Team, VA Medical Center, Minneapolis, MN
`
`Attending Staff, Erectile Dysfunction Clinic, VA Medical Center, Minneapolis, MN
`
`Case reviewer, Medical Care Management Corporation, LLC, Bethesda, MD
`
`Director for Mental Health and Clinical Research, Miami Jewish Health Systems, Miami, FL
`
`Director, Geriatric Psychiatry Outpatient Clinic, Miami VA Medical Center, Miami, FL
`
`Associate and Psychiatric Consultant, Child and Family Psychologists, Weston, FL
`
`Psychiatric consultant, United States DepartmentofJustice
`
`Consulting Psychiatrist, Weston PsychCare, P.A., Weston, FL
`
`Consulting Psychiatrist, Alexander Nininger Veterans’ Administration Nursing Home,
`PembrokePines, FL
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`2006 - 11
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`Consulting Psychiatrist, Golden Palms Residential Treatment Center
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`2009-
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`2018 -
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`Peer Reviewer, Focus Behavioral Health
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`Peer reviewer and forensic consultation, The Forensic Panel
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`Professional Memberships
`
`1991 -
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`Member, American Psychiatric Association (APA)
`
`Marc E. Agronin, MD / Bio and CV 2022/ Page 2
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`
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`1992 -
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`1997 - 07
`
`2014 - 18
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`2016 -
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`Awards
`
`Member, American Association for Geriatric Psychiatry (AAGP) (President, 2022-23)
`
`Member,International Society for the Study of Personality Disorders (ISSPD)
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`National Center for Creative Aging (Board member and VP, 2015 - 17)
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`Gerontological Society of America
`
`2008
`
`2011
`
`2012
`
`2013
`
`2013
`
`2016
`
`2019
`
`2022
`
`Clinician of the Year, American Association for Geriatric Psychiatry
`
`Distinguished Fellow, American Psychiatric Association
`
`Finalist, Greater Miami Chamber of Commerce Health Care Heroes Award
`
`Finalist, Greater Miami Chamber of Commerce Health Care Heroes Award
`
`Excellence in Research and Education Award, LeadingAge
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`Fearless Caregiver Clinician Award
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`Distinguished Fellow, American Association for Geriatric Psychiatry
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`Distinguished Ambassador in Aging Award, Aging Life Care Association
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`Peer Review Journals
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`| have served as a peer reviewer for the following journals: Journal of the American Geriatrics Society, American Journal
`of Geriatric Psychiatry, and the American Journal of Alzheimer's Disease
`
`Pharmaceutical Speakers Bureaus and Advisory Panels
`
`2000 - 08
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`2001 - 04
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`2003 - 09
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`2006 - 07
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`2006 - 10
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`2008 - 14
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`2009 - 10
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`2011 - 13
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`2011 - 12
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`2011 - 14
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`2012 - 13
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`Janssen Pharmaceutica: speakers bureau for Risperdal, Razadyne ER, Invega ER
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`Organon,Inc: Long-term care advisory panel (2001-02), and speakers’ bureau for Remeron
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`Forest Pharmaceuticals: speakers bureau for Lexapro and Namenda
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`Abbott Laboratories: speakers bureau for Depakote ER
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`Astra-Zeneca: speaker’s bureau for Seroquel ER
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`Novartis speakers bureau for Exelon Patch
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`Merck speakers bureau for Asenapine
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`Accera speakers bureau for Axona, and advisory board member
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`Avanir speakers bureau for Nuedexta
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`AssureX speakers bureau for GenesightX
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`Eli Lilly speakers bureau and consultant for Amyvid
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`Marc E. Agronin, MD / Bio and CV 2022/ Page 3
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`
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`2013 - 15
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`Actavis / Forest speakers bureau for Namenda XR
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`2015 - 18
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`Allergan speakers bureau for Namzeric
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`2016 - 17
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`Eli Lilly speakers bureau for Amyvid reader training
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`Organizational and Administrative Positions
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`1984-87
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`1985-87
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`1985-87
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`1987-88
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`1988-91
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`1991-95
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`1996 - 18
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`1996 - 97
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`1997
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`1996 -99
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`1997 - 98
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`1998 - 99
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`1999 - 14
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`1999 - 02
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`1999 -01
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`2002 - 05
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`2003
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`2003 - 06
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`2005 - 08
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`2005-
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`2008 - 14
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`The Harvard Crimson,Editor (Daily student newspaper, Harvard University)
`Circulation Manager (1985-86), Staff cartoonist (1985-87), General Manager (1986-87)
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`The William James Society, Founder and President
`- A student psychology organization at Harvard University
`
`The Harvard Psychological Review, Founder and Publisher
`- Asemi-annual psychology journal
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`Member, BoardofDirectors, Erik Erikson Center, Cambridge. MA
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`Editor, Yale Journal of Biology and Medicine (Book Review Editor, 1990-91)
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`Premedical Tutor, Harvard Medical School
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`Alumnus Interviewer, Harvard University Admission Committee
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`Member, Medical Advisory Committee, Shalom Home,Inc., Minneapolis, MN
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`Fundraising Training Co-chair, St. Paul United Jewish Fund and Council, St. Paul, MN
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`Committee Memberships, VA Medical Center, Minneapolis, MN: Geriatric Residency Training,
`Ethics, Medical Records, and Physician Professional Standards Board
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`Chairman, Psychiatry Morbidity and Mortality Committee, VA Medical Center, Minneapolis, MN
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`Editorial committee, Geriatric Psychiatry Self-Assessment Program, published 1999
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`Ethics Committee member, Miami Jewish Health Systems
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`Planning and Program Selection Committee, AAGP Annual Meeting 2000, 2001, 2002
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`Co-chairman, AAGP / Bristol-Myers Squibb Fellowship Selection Committee
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`Member, Board of Directors, Alzheimer’s Association/South Florida Chapter
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`Member,Florida Statewide Steering Committee on Dementia Training
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`Editorial Board, The Carlat Report, monthly psychopharmacology newsletter
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`Editorial Board, CNS News and CNS Seniorcare, McMahon Publishing, New York, NY
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`Behavioral Expert Panel, The Oak Group / VitalHub, Wellesley, MA and Toronto, ON
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`Medical Editor, American Association for Geriatric Psychiatry Newsletter
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`Marc E. Agronin, MD / Bio and CV 2022/ Page 4
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`2011-15
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`Board of Directors, Temple BethIsrael, Sunrise, FL
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`2012-13
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`Camp Physician, Camp Interlaken JCC, Eagle River, WI for 1 week each summer
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`
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`2013-15_—_Board of Directors, American Association for Geriatric Psychiatry
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`2014-15
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`Advisory Board, Psychiatric Clinics of North America Journal
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`2014-18
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`Board of Directors, National Center for Creative Aging (Vice President, 2015 - 17)
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`2018-19
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`Treasurer / Secretary, American Association for Geriatric Psychiatry
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`2022 -
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`President, American Association for Geriatric Psychiatry
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`Competitive Fellowships and Institutes
`
`1993-95 Mead Johnson Fellow, American Association for Geriatric Psychiatry (AAGP)
`- A two-year fellowship to sponsor participation in AAGP activities and annual meetings
`
`1997
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`Participant, Summer Research Institute in Geriatric Psychiatry (sponsored by the AAGP)
`- A week long research training seminar, funded by the National Institute of Mental Health
`
`Forensics Work
`
`Since 2002 | have reviewed cases, conducted evaluations or served as an expert witnessin 15 legal cases, including the US
`Justice Department and the US Attorney’s office in San Francisco, CA. The following cases involved being deposed and
`testifying in court or in front of an arbitration panel:
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`2010
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`2011
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`2013
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`2104
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`2015
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`2016
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`2021
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`2021
`
`Deposition and court testimonyas treating psychiatrist for plaintiff in Waters (Steven Dunn / Scott Sandler) vs
`Royal Caribbean Cruises, LTD (Mcintosh, Sawran, Peltz & Cartaya), Dade County, FL
`Issue: Psychiatric status of plaintiff during treatment
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`Deposition and court testimony as expert witnessfor plaintiff in State of Florida vs Infosino (Public Defender
`office, Palm Beach County, FL)
`Issue: Psychiatric status of defendant during alleged murder
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`Deposition and court testimony as expert witnessforplaintiff in Wells Fargo / Kritchman (Heller Waldman) vs
`Spiegal (Kluger, Kaplan, Silverman, Katzen), Dade County, FL
`Issue: Decision making capacity of plaintiff to revise will
`
`Deposition and court testimony as expert witness for defendantin Hall (Rodriguez) vs Hall (Chepenik
`& Trushin), Dade County, FL
`Issue: Decision making capacity of defendantto revise will
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`Deposition as expert witness for defendant in Salas (McClosky) vs Kinast (Chepenik &Trushin), Dade County, FL
`Issue: Decision making capacity of defendantto revise will
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`Expert peer reviewer and expert witnessin front of arbitration panel for Speer vs Morgan Stanley (The Forensic
`Panel). Issue: Probability of dementia diagnosis in client of defendant to make investment decisions
`
`Deposition as expert witness for defendantin Dollison, Elizabeth vs Tequesta Trace (Wicker Smith O’Hara McCoy &
`Ford, P.A.). Issue: Whether there was a needfor psychiatric intervention following resident-on-resident assault
`
`Expert peer reviewer and expert witness for defendant in USA vs Robert Brockman (The Forensic
`Panel). Issue: Competencyto stand trial
`
`Marc E. Agronin, MD / Bio and CV 2022 / Page 5
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`Research Experience
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`1996 —99
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`1996 —-97
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`1997 —99
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`Principal Investigator: "Personality Disorders in a Geriatric Psychiatry Outpatient Clinic," Protocol #2268, VA
`Medical Center, Minneapolis, MN
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`Co-investigator: "A randomized, double-blind, placebo controlled study of risperidone for treatment of
`behavioral disturbances in subjects with dementia.” Protocol # RIS-USA-63B. Principal Investigator: Maurice
`Dysken, MD, VA Medical Center, Minneapolis, MN
`
`Sub-investigator: "A multicenter, double-blind comparison of efficacy and safety of Seroquel (quetiapine
`fumarate), haloperidol, and placeboin the treatmentof elderly subjects residing in nursing homesor
`assisted care facilities and presenting with Alzheimer's dementia and psychosesor other selected
`psychoses. Trial # 50771L/0039. Principal Investigator: Maurice Dysken, MD, VA Medical Center,
`Minneapolis, MN
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`In all the following studies at Miami Jewish Health, | served as the principal investigator:
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`1999 —03
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`2000 — 02
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`2001 — 02
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`2002 — 03
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`2002 — 03
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`2003 -05
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`2004-05
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`2004 — 06
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`2004-05
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`A multicenter, randomized, double-blind, placebo flexible dose study of Aripiprazole in the treatment of
`nursing home patients with psychosis associated with dementia of the Alzheimer's Type. Protocol # CN-138-
`005. Sponsor: Bristol-Myer Squibb.Fixed dose arm Protocol # CN-138-004 completed 2003
`
`A Double-Blind, Placebo-controlled Study of Depakote in the Treatment of Behavioral Agitation in Elderly
`Patients with Dementia.Protocol #M99-082. Sponsor: Abbott Laboratories.
`
`Multi-center, Open label Study of the Efficacy and Safety of Remeron SolTab (mirtazapine) Orally Disintegrating
`Tablets in Long-term Care Subjects with Physician-diagnosed Depression Who Areat Least 70 Years of
`Age.Protocol # 003050. Sponsor: Organon.
`
`A Study to Evaluate the Efficacy, Safety, and Maintenance Effect of Risperidone Augmentation of SSRI
`Monotherapy in Young and Older Adult Patients with Unipolar Treatment Resistant Depression. Protocol RIS-
`INT-93. Sponsor: Janssen Pharmaceutica.
`
`A multicenter, double-blind, randomized comparison ofthe efficacy and safety of quetiapine fumarate
`(SEROQUEL) and placeboin the treatmentof agitation associated with dementia. Protocol STAR 0046. Sponsor:
`Astra-Zeneca.
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`“A Phase Il Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled, Multicenter, Safety and Efficacy
`Evaluation of Three Doses of NS 2330 in Patients with Mild to Moderate Dementia of the Alzheimer’s Type.”
`Protocol 1198.52. Sponsor: Boehringer Ingelheim.
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`“A Double-Blind Placebo Controlled Pilot Tolerability Study of Intramuscular Aripiprazole in the Treatment of
`Acutely Agitated Patients with a Diagnosis of Alzheimer’s, Vascular or Mixed Dementia — CN138-131-014.
`Sponsor: Bristol-Myer Squibb.
`
`“A Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Effectiveness of Memantine in
`Nursing Home Residents with Moderate to Severe Azheimer’s Disease. Protocol MEM-MD-22. Sponsor: Forest
`Laboratories.
`
`“A 24-week, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group Evaluation
`of the Efficacy, Safety, and Tolerability of the Once-daily Exelon Patch Formulation in Patients with Probably
`Alzheimer’s Disease (MMSE 10-20).” Protocol No. CENA713D2320. Sponsor: Novartis Pharmaceuticals
`Corporation.
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`2005 — 06
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`“Double-Blind Phase 3, Two-Week, Placebo-Controlled Study of Methylnatrexone (MNTX)for the Relief of
`Constipation Due to Opioid Therapy in Advanced Medical Illness.” Protocol No. MNTX-302 and 302EXT(“A
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`Marc E. Agronin, MD / Bio and CV 2022 / Page 6
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`
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`2005 — 06
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`2005 — 07
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`2005 — 08
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`2005 — 08
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`2005 — 06
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`2006 — 07
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`2006 — 07
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`2006 — 07
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`2006 - 09
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`2006 — 07
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`2007
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`2006 — 07
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`2007
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`Three-Month Open-Label Treatment Extension of Protocol MNTX302). Sponsor: OmnicareClinical Research,
`Inc.
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`“A Phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin Versus
`Vancomycin for Treatment of Hospital-Acquired Pneumonia with a Focus on Patients with Infections Due to
`Methicillin-Resistant Staphylococcus aureus.” Sponsor: Theravance. Protocol No. 0019.
`
`“A Double-Blind, PhaseIl, Safety and Efficacy Evaluation of ONO-2506POin Patients with Mild to Moderate
`Alzheimer’s Disease.” Protocol ONO-2506POU101. Sponsor: ONO Pharmaceutical Co., LTD, and PharmaNet,
`LLC.
`
`“A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in
`Patients with Moderate to Severe Dementia of the Alzheimer’s Type.” Protocol MEM-MD-50 / MEM-54 (open-
`label extension phase). Sponsor: Forest Laboratories.
`
`“A Randomized, Double-Blind, Placebo-Controlled, Efficacy, Safety, and Tolerability Study of Bifeprunox in the
`treatment of Elderly Subjects with Psychosis and Behavioral Disturbances Associated with Dementia of the
`Alzheimer’s Type.” Protocol #$1543016. Sponsor: Solvay Pharmaceuticals, Inc.
`
`“A multicenter, randomized, open-label, parallel design trial to compare time to response in the symptoms of
`anxiety to concomitant treatment with Niravam and a SSRI or SNRI to treatment with an SSRI or SNRI alone in
`subjects with Generalized Anxiety Disorder or Panic Disorder.” Protocol #SP851. Sponsor: Schwarz Pharma,
`Inc. / Omnicare Clinical Research.
`
`“A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of MEM
`1003 in Patients with Mild to Moderate Alzheimer’s Disease.” Protocol MEM-1003-004. Sponsor: Memory
`Pharmaceuticals Corp.
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`“A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy, Safety, and tolerability of 8 Week
`Treatment of Rozerem 8 mg (QHS)in Sleep Disturbed, Community-Dwelling, Mild to Moderately Severe
`Alzheimer’s Disease Subjects.” Protocol 01-05-TL-375-061. Sponsor: Takeda Pharmaceuticals
`
`“A randomized, parallel group, multiple-dose, 6-week study to evaluate safety, tolerability, and
`pharmacokinetics of asenapine in elderly subjects with psychosis.” Protocol
`#A7501021 Sponsor: Organon USA,Inc.
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`“An open-label, randomized, multi-center, controlled study of PROCRIT (Epoetin alpha) for the treatment of
`anemia of chronic kidney disease in the long term care setting.”
`Protocol# EPOCKD2002. Sponsor: Ortho-Biotech Clinical Affairs, LLC.
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`“An open-label, multi-center study to assess the safety of AVP-923 (Dextromethorphan/Quinidine) in the
`treatment of patients with pseudobulbar affect.” Protocol# 02-AVR-107. Sponsor: INC Research / Avanir
`Pharmaceuticals.
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`“MCI community validation study.” Protocol# A2501051. Sponsor:Esai Inc./ Pfizer, Inc.
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`“Obtaining clinical evidence in elderly subjects with diabetes to support guidelines for converting from two or
`moreoral anti-diabetic agents to NovoLog Mix 70/30 insulin.” Protocol BIAsp-1304. Sponsor: Novo Nordisk
`Inc..
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`“A randomized, double-blind, placebo-controlled, Phase 11a studyto assess the short-term effects of PRX-
`03140 alone and in combination with donepezil in subjects with mild Alzheimer’s disease.” Protocol# PRX-
`03140. Sponsor: EPIX Pharmaceuticals, Inc.
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`Marc E. Agronin, MD / Bio and CV 2022 / Page 7
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`
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`2007
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`2008 — 12
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`2008 - 12
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`2008 - 12
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`2008 - 10
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`2008 - 10
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`2009-10
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`2009
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`2009 - 13
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`2009
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`2010- 13
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`2010
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`2011- 14
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`2011 - 14
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`2011 - 13
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`2012- 13
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`“A Phase 2 Randomized, Placebo-Controlled, Dose-Ranging Study of the Safety and Efficacy of ELNDOO5 (Scyllo-
`inositol) in Mild to Moderate Alzheimer’s Disease.” Protocol #ELNDOO5-AD201. Sponsor: Elan {Pharmaceuticals.
`
`“A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety
`Trial of Bapineuzumab (AAB-001, ELN115727) in Patients with Mild to Moderate Alzheimer’s Disease who are
`Apolipoprotein E4 Non-carriers (Protocol ELN115727-301) and Carriers (Protocol ELN115727-302). Sponsor:
`Elan Pharmaceuticals.
`
`“Effect of LY450139 a gamma-secertase inhibitor, on the progression of Alzheimer’s as compared to placebo.”
`Protocol H6L-MC-LFBC. Sponsor: Eli Lilly.
`
`Wyeth Study: MTX (to be added)
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`“Rotavirus Burden of Diseasein the Institutionalized Elderly.” Protocol # EPO8100.011. Sponsor: Merck
`Pharmaceutical.
`
`“CONNECTION: A Global Phase 3, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Oral Dimebon
`in Patients with Mild-Moderate Alzheimer’s Disease.” Protocol DIM14. Also Open-label extension phase DIM-
`18. Sponsor: Medivation, Inc.
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`“A phaseIll study of the correlation between Florpiramine F 18 (F-AV-45) PET Imaging and Amyloid Pathology.
`Protocol: AV-45-A07 Sponsor: Avid Radiopharmaceuticals.
`
`“A Randomized, placebo-Controlled Study in Elderly Alzheimer’s Subjects on a Established and Well Tolerated
`Doseof Aricept to Assess Skin Tolerability, Skin Irritation and Adhesion with Three Consecutive Seven-Day
`Applications of the 350 mg Donepezil Transdermal Patch-System.” Protocol:TPU-TAD-US02-0810 . Sponsor:
`Teikoku Pharma USA.,Inc.
`
`“Effect of passive Immunization on the progression of Alzheimer’s Disease: Solanezumab (LY2062430) versus
`Placebo” Protocol: H8A-MC-LZAN. Sponsor: Eli Lilly and Company.
`
`“Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of
`Oral Lixivaptan Capsules in Subjects with Euvolemic Hyponatremia”. Protocol: CK-LX3430. Sponsor: Cardiokine
`Biopharma,LLC.
`
`“A Principal Open label Study to Assess the Prognostic of Usefulness of Flumetamol (F18) Injection for
`Identifying Subjects with Amnestic Mild Cognitive Impairment Who Will Convert to Probable Alzheimer’s
`Disease”. Protocol: GE-067-005. Sponsor: GE Healthcare Ltd and itsaffiliates.
`
`“A Principal Open-Label Study to Compare the Brain Uptake of (18 F) Flumetamol with Brain Amyloid levels
`Determined Post-Mortem. Protocol: GE-067-007. Sponsor: GE HealthcareLtd and its affiliates.
`
`“Continued Efficacy and safety of Solanezumab, an Anti-Amyloid beta Antibody in patients with AD. An open
`label extension for all patients completing LZAN.” Protocol H8A-MC-LZAO. Sponsor: Eli Lilly and Company.
`
`“A PhaseIl, 24 month, Multicenter, randomized, Double Blind, placebo- Controlled, Parallel Group, Amyloid
`Imaging Positron Emission Tomography (PET) and safety Study of ACC-001 and QS-21 in Adjuvant in Subjects
`with Mild to Moderate Alzheimer's Disease. Sponsor: Janssen Pharmaceutica.
`
`“A phase 2, Multicenter, 234 Month, randomized, Third Party Unblinded, Placebo- Controlled, Parallel Group
`Amyloid Imaging Positron Emission Tomography (PET) and Safety Trial of ACC-001 (vanutide cridificar) and QS-
`21 Adjuvant in Subjects with Early Alzheimer's Disease.” Sponsor: Pfizer Pharmaceuticals.
`
`“A Multinational, Multicenter, randomized, double blind, parallel group, placebo - controlled study of the
`effect on cognitive performancesafety, and tolerability of SAR1100894Dat the dosesof 0.5 mg, 2 mg, and 5
`
`Marc E. Agronin, MD / Bio and CV 2022 / Page 8
`
`
`
`2012- 13
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`2012-14
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`2012 - 13
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`2012 - 13
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`2012 -13
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`2012 -16
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`2012 - 17
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`2012 - 14
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`2012 — 13
`
`2012-15
`
`2012-15
`
`2013 — 14
`
`2013 - 15
`
`mg/day for 24 weeksin patients with mild to moderate Alzheimer's Disease on stable Donepezil therapy.”
`Sponsor: Sanofi-Aventis Pharmaceuticals.
`
`“A randomized Double Blind placebo-controlled, parallel group, Multicenter, phase III Study of MABT5102Ain
`Patients with Mild to Moderate Alzheimer's Disease.” Sponsor: Genentech Pharmaceuticals.
`
`“A PhaseIll. Randomized, Double Blind, Placebo-Controlled Study of the Efficacy, Safety, and tolerability of a
`single infusion of MK-6072 (Human Monoclonal Antibodyto C.Difficile Toxin B) and MK-3415A (Human
`Monoclonal Antibodyto C.Difficile Toxin A and B ) in patients receiving Antibiotic therapy for C. Difficile
`Infection.” Sponsor: Merck.
`
`“A Phase 1, Multicenter, Randomized, Double-blind, Sequential Cohort, Placebo-controlled Trial to Assess the
`Safety and Tolerability of Ascending Multiple Oral Doses of Brexpiprazole as Adjunctive Therapyin the
`Treatmentof Elderly Subjects With Major Depressive Disorder. Protocol # 331-12-291 .Sponsor: Otsuka
`
`“A Randomized, Double Blind, Parallel Group - Controlled PhaseII Efficacy and Safety. Study of Dose groupsof
`study x Adjunct to current antidepressant Therapy in patients with Major Depressive Disorder who Exhibit an
`Inadequate Repose to Antidepressants. Protocol# LNBQ. Sponsor: Astra-Zeneca
`
`“Feasibility Study: Safety and Efficacy Assessment of SAPPHIRE II System to Aid in the Diagnosis of Probable
`Alzheimer’s disease in twenty normal subjects and twenty patients with probable Alzheimer’s disease.
`Sponsor: Cognoptix
`
`“A 26-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of
`Daily Administration of AC-1204 in Participants with Mild to Moderate Alzheimer's Disease (AD) with an
`Optional 26-Week Open-label Extension.” Protocol NOURISH AD / AC-12-010. Sponsor: Accera
`
`“A Placebo-controlled, Double-blind, Parallel-group, Bayesian Adaptive Randomization Design and Dose
`Regimen-finding Study to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early
`Alzheimer’s Disease.” Protocol BAN2401-GO00-201. Sponsor: Eisai
`
`“A Placebo-controlled, double-blind study to evaluate the safety, efficacy, and tolerability of AVP-923, an oral
`medication (dextromethorphan/quinidine) for the treatment of symptomsof agitation in patients with
`Alzheimer's disease. Protocol # 12-AVR-131. Sponsor: Avanir Pharmaceuticals.
`
`“A Randomized, Double Blind, placebo-Controlled, Multicenter Study to evaluate the Efficacy, Safety
`and Tolerability of JNJ42160443 as adjunctive Therapy in Subjects with Cancer Related Pain. Followed by
`an Open Label, Extension.” Protocol# 42160443PAI2001. Sponsor: Johnson & Johnson.
`
`“A Randomized, Double Blind, placebo-Controlled, Multiple-Dose Study to the Safety, Tolerability,
`Pharmacokinetics, and Pharmacodynamics of BIIBO37 in Subjects with Mild or Prodomal Alzheimer's Disease.”
`Protocol 221AD103. Sponsor: Biogen
`
`“A Phase 2, Randomized, Double-Blind Placebo Controlled Study to Assess the Efficacy and Safety Of
`RO4602522 addedto background Alzheimer’s disease therapyin patients with moderate severity Alzheimer’s
`disease.” Protocol #BP28428. Sponsor: Hoffman-La Roche Ltd.
`
`“A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 18-Month Safety and Efficacy Study of
`Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Mild Alzheimer’s Disease.” Protocol #
`TRx-237-005. Sponsor: TauRx Therapeutics Ltd.
`
`“A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 26-Week, Phase 3 Study of Two Dosesof
`EVP-6124or Placebo in Subjects with Mild to Moderate Alzheimer’s Disease Currently or Previously Receiving
`an Acetylcholinesterase Inhibitor Medication. Protocol# EVP-6124-024. Sponsor: Forum Pharmaceuticals.
`
`Marc E. Agronin, MD / Bio and CV 2022 / Page 9
`
`
`
`2013 - 15
`
`2013 -
`
`2013 -
`
`2013 — 15
`
`2013
`
`2013 - 16
`
`2014 - 16
`
`2014 — 16
`
`2014 - 18
`
`2014 - 17
`
`2014 - 17
`
`2015 - 17
`
`2015 -17
`
`2015 - 18
`
`“A 26-Week Extension Study of the Safety and Clinical Effects of EVP-6124 in Subjects with Alzheimer’s Disease
`Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication. Protocol# EVP-6124-026.
`Sponsor: Forum Pharmaceuticals.
`
`“A phase 3, 12-week, multicenter, randomized, double-blind, placebo controlled trial to evaluate the efficacy,
`safety, and tolerability of 2 fixed doses of brexpiprazole (OPC-34712) in the treatmentof subjects with
`agitation associated with dementia of the Alzheimer’s type. Protocol # 331-12-283. Sponsor: Otsuka
`Pharmaceutical Development and Commercialization,Inc.
`
`“A 2-month, Observational, Rollover Trial to Evaluate the Safety of Subjects with Agitation Associated with
`Dementia of the Alzheimer’s Type who werePreviously Treated with Brexpiprazole (OPC-34712) or Placeboin
`a Phase 3, Double-blind Trial.” Protocol # 331-12-211. Sponsor: Otsuka Pharmaceutical Development and
`Commercialization, Inc.
`
`“A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy,
`Safety, and Tolerability of 3 Fixed Doses of ELNDOOSin the Treatmentof Subjects with Agitation Associated
`with Dementia of the Alzheimer’s Type.” Protocol ELND005-AG201. Sponsor: Elan Pharmaceuticals.
`
`“A Phase 2, Randomized, Double-Blind Placebo Controlled Study to Assess the Efficacy and Safety Of NBI-
`98854 For The TreatmentOf Tardive Dyskinesia In Subjects With Schizophrenia Or Schizoaffective Disorder.”
`Protocol NBI-98854-1201. Sponsor: Neurocrine Biosciences,Inc.
`
`“A phaseIll, randomized, placebo-controlled, parallel group, double-blind clinical trial to study the efficacy and
`safety of MK-8931 in subjects with amnestic mild cognitive impairment due to Alzheimer’s disease (prodromal
`AD).” Protocol # MK8931-019. Sponsor: Merck Pharmaceuticals.
`
`“Effect of NeuroAD, Combined TMS Stimulation and Cognitive Training, on the cognitive function of Mild to
`Moderate Alzheimer Patients.” Protocol # NRX-US4. Sponsor: Neuronix Ltd.
`
`Effect of Passive Immunization on the Progression of Mild Alzheimer's Disease: Solanezumab (LY2062430)
`Versus Placebo (LZAX). Protocol: H8A-MC-LZAX. Sponsor: Eli Lilly.
`
`“A phaseIll, randomized, double-blind, placebo-controlled, parallel-group, multicenter efficacy and safety
`study of gantenerumab in patients with mild Alzheimer’s disease.” Protocol # WN28745. Sponsor: Hoffman
`LaRoche Marguerite Road.
`
`“A PhaseIl, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple Ascending Dose Study to Evaluate
`the Safety and Tolerability of Donepezil with Solifenacin in Patients with Alzheimer’s Disease Type Dementia.”
`Protocol # CPC-001-07. Sponsor: Chase Pharmaceuticals
`
`“A Randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study of Lu AE58054in patients
`with mild-moderate Alzheimer’s disease treated with donepezil. Protocol # 14862A. Sponsor: H. Lundbeck A/S.
`
`“Randomized, double-blind, placebo controlled, multi-center registration trial to evaluate the efficacy and
`safety of TTP488 in patients with mild Alzheimer’s disease receiving acetylcholinesterase inhibitors and/or
`memantine. (Note: TTP488 (azeligaron) is a RAGE antagonist). Protocol TTP488-301. Sponsor: Transtech
`Pharma, LLC
`
`“A Study to Assess Effectiveness, Safety, and Health-related Outcomes of NUEDEXTA® (Dextromethorphan
`Hydrobromide and Quinidine Sulfate) for the Treatment of Pseudobulbar Affect (PBA) in Nursing Home
`Patients.” Protocol # 15-AVR-404. Sponsor: Avanir Pharmaceuticals, Inc.
`
`“A Phase 3, Multicenter, Long-term, Extension Study of the Safety and Efficacy of AVP-786 (deuterated [d6]
`dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the Treatment of Agitation in Patients
`with Dementia of the Alzheimer’s Type.” Protocol# 15-AVP-786-301/303. Sponsor: Avanir Pharmaceuticals,Inc.
`
`Marc E. Agronin, MD / Bio and CV 2022 / Page 10
`
`
`
`2015 - 17
`
`2015 - 19
`
`2015- 18
`
`2015 - 19
`
`2015 - 19
`
`2016 - 19
`
`2016 - 18
`
`2016 - 18
`
`2017 - 19
`
`2017 - 18
`
`2018 -
`
`2018 -19
`
`2018 -
`
`2018 -
`
`2018 -
`
`“A 24-month, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, Safety,
`Tolerability, Biomarker, and Pharmacokinetic Study of AZD3293 in Early Alzheimer’s Disease (The AMARANTH
`Study).” Protocol #18D-MC-AZES.Sponsors: Astra-Zeneca / Eli-Lilly and Company.
`
`“A phase 1B, multicenter, randomized, placebo-controlled, double-blind, multiple-dose study to assess the
`safety, tolerability, and pharmacokinetic