SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study



Status:Active, not recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 85
Updated:11/3/2018
Start Date:September 2015
End Date:May 2019

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A Phase 2a Multicenter, Randomized, Double-Blind, Parallel Group, 26-Week, Placebo-Controlled Study of SUVN-502 in Subjects With Moderate Alzheimer's Disease Currently Treated With Donepezil Hydrochloride and Memantine Hydrochloride

This is a phase 2a, proof-of-concept, 26-week, double-blind, multicenter, randomized,
parallel group, placebo-controlled study to compare the efficacy and safety of treatment with
SUVN-502 to placebo treatment in subjects with moderate Alzheimer's disease receiving stable
doses of donepezil HCl and memantine HCl.

This is a phase 2a, proof-of-concept, 26-week, double-blind, multicenter, randomized,
parallel group, placebo-controlled study to compare the efficacy and safety of treatment with
SUVN-502 to placebo treatment in subjects with moderate Alzheimer's disease receiving
donepezil HCl (10 mg qd) and either memantine HCl (10 mg twice daily [bid]) or Namenda XR®
(28 mg qd) or the combination therapy, Namzaric™

The primary objective of the study is to evaluate the efficacy of a serotonin receptor
subtype 6 (5-HT6) antagonist, SUVN-502, compared to placebo, as adjunct treatment in subjects
with moderate Alzheimer's disease (Mini-Mental State Examination [MMSE] score of 12 to 20)
currently treated with the acetylcholinesterase inhibitor, donepezil hydrochloride (HCl), and
the N-methyl-D-aspartic acid (NMDA) antagonist, memantine HCl. Efficacy will be assessed by
the 11-item Alzheimer's Disease Assessment Scale for Cognitive Behavior (ADAScog-11) after 26
weeks of treatment.

Inclusion Criteria:

- Has a diagnosis of probable Alzheimer's disease based on the NINCDS-ADRDA criteria at
least 1 year prior to the screening visit.

- Has a score between 12 and 20 inclusive on the MMSE at the screening and baseline
visits.

- Has a MRI or CT scan performed within 12 months prior to screening with findings
consistent with the diagnosis of dementia due to Alzheimer's disease without any other
clinically significant comorbid pathologies.

- Must be receiving treatment with stable doses of donepezil HCl and memantine HCl for
at least 3 months prior to the screening visit

- Availability of an eligible and reliable caregiver

- Must be living in the community or an assisted living facility.

- Must be ambulatory or ambulatory aided (use of cane or walker).

- Is not pregnant or planning to become pregnant during the study.

- Subject (or subject's legally acceptable representative) and caregiver must sign an
Informed Consent to participate in the study.

Exclusion Criteria:

- Has a diagnosis of dementia due to other than Alzheimer's Disease

- Is taking cholinesterase inhibitors other than donepezil HCl or taking doses of
donepezil HCl other than 10 mg

- Is taking doses of memantine HCl other than 10 mg bid or Namenda XR® 28 mg qd.

- Has uncontrolled cardiac disease or hypertension.

- Has clinically significant renal or hepatic impairment.

- Has cancer or a malignant tumor, untreated thyroid disorder or has a history of
seizure disorder

- Is treated or likely to require treatment during the study, with any medications
prohibited by the study protocol.
We found this trial at
71
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Princeton, New Jersey 08540
Principal Investigator: Jeffrey Apter
Phone: 609-921-3555
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3924 9th Avenue West
Bradenton, Florida 34205
Principal Investigator: William McElveen
Phone: 941-708-0005
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3500 Camp Bowie Boulevard
Fort Worth, Texas 76107
Principal Investigator: Janice Knebl
Phone: 817-735-0647
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736 E Bullard Ave
Fresno, California 93710
559-437-9700
Principal Investigator: Perminder Bhatia
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4085 University Blvd S # 1
Jacksonville, Florida 32216
Principal Investigator: Erin Doty
Phone: 904-732-6683
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3540 Northwest 88th Avenue
Sunrise, Florida
Principal Investigator: Richard Singer
Phone: 954-475-8171
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2919 Swann Avenue
Tampa, Florida 33609
813-353-9613
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3212 Cove Bend Drive
Tampa, Florida 33613
Phone: 813-971-8311
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823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
Principal Investigator: Scott Teeter
Phone: 785-368-0744
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Albany, New York 12208
Principal Investigator: Richard Holub
Phone: 518-426-0575
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Allentown, Pennsylvania 18105
Principal Investigator: Lorraine Spikol
Phone: 610-402-8249
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Atlantis, Florida 33462
Principal Investigator: Mark Goldstein
Phone: 561-968-2933
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Baltimore, Maryland 21285
Principal Investigator: Scott Aaronson
Phone: 410-938-3125
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Bangor, Maine 04401
Principal Investigator: Clifford Singer
Phone: 207-973-6100
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6400 Perkins Rd
Baton Rouge, Louisiana 70808
(225) 763-2500
Principal Investigator: Jeffrey Keller
Phone: 225-763-3190
Pennington Biomedical Research Center Unlike other medical research facilities where science occurs in separate labs...
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Brooklyn, New York 11235
Principal Investigator: Nick Vatakis
Phone: 718-616-2247
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Brooklyn, New York 11229
Phone: 718-444-7774
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Canton, Ohio 44718
Principal Investigator: Ryan Drake
Phone: 330-494-2097
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Centerville, Ohio 45459
Principal Investigator: Meenakshi Patel
Phone: 937-208-8298
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Charleston, South Carolina 29401
Principal Investigator: Jacobo Mintzer
Phone: 843-740-1592
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Charlotte, North Carolina 28270
Principal Investigator: Mohammad Bolouri
Phone: 704-364-4000
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Charlotte, North Carolina 28204
Principal Investigator: Santosh Gopalakrishnan
Phone: 828-437-8282
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Cleveland, Ohio 44195
Principal Investigator: Kasia Gustaw Rothenberg, Dr
Phone: 216-445-4149
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Costa Mesa, California 92626
Principal Investigator: Gustavo Alva
Phone: 714-277-4472
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Decatur, Georgia 30030
Principal Investigator: Kimball Johnson, Dr
Phone: 404-537-1281
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Delray Beach, Florida 33445
Principal Investigator: Mark Brody
Phone: 561-374-8461
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Fairfield, Connecticut 06824
Principal Investigator: Srinath Kadimi
Phone: 203-358-8879
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Fullerton, California 92835
Principal Investigator: Anthony Ciabarra
Phone: 714-879-7200
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Indianapolis, Indiana 46202
Principal Investigator: Martin Farlow
Phone: 317-963-7402
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Laguna Hills, California 92653
Principal Investigator: Robert Feldman
Phone: 949-588-0909
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Lewisville, Texas 75067
Principal Investigator: Timothy Shepherd
Phone: 972-420-8444
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Lexington, Kentucky
859) 257-9000
Phone: 859-323-5550
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Long Beach, California 90806
Principal Investigator: Omid Omidvar
Phone: 562-304-1759
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Los Angeles, California 90095
Principal Investigator: Sarah Kremen, Dr
Phone: 310-794-6191
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Miami, Florida
Principal Investigator: Francisco Ricart
Phone: 305-285-0705
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Naples, Florida 34102
Principal Investigator: William Justiz
Phone: 239-434-0332
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New Windsor, New York 12553
Principal Investigator: Sashi Makam
Phone: 844-337-8839
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New York, New York 10021
Principal Investigator: Ram Shrivastava
Phone: 212-288-0138
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New York, New York 10022
Principal Investigator: Judith Joseph
Phone: 646-678-4196
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70 Washington Square S
New York, New York 10012
(212) 998-1212
Principal Investigator: Martin Sadowski
Phone: 516-470-6933
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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Oklahoma City, Oklahoma 73103
Principal Investigator: Louise Thurman
Phone: 405-235-8188
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Principal Investigator: Carl Griffin
Phone: 405-602-3926
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Palm Beach Gardens, Florida 33418
Principal Investigator: Michael Tuchman
Phone: 561-282-5538
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1775 West Dempster Street
Park Ridge, Illinois 60068
(847) 723-2210
Principal Investigator: Darren Gitelman
Phone: 847-720-6464
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Pensacola, Florida 32514
Principal Investigator: David Bear, Dr
Phone: 850-837-6880
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Pensacola, Florida 32502
Principal Investigator: Kevin Groom
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Phoenix, Arizona 85006
Principal Investigator: William Burke
Phone: 402-552-6062
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Phoenix, Arizona 85013
Principal Investigator: Marwan Sabbagh
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Plains, Pennsylvania 18705
Principal Investigator: Mario Cornacchione
Phone: 570-207-3945
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Port Charlotte, Florida 33952
Principal Investigator: Liliana Montoya
Phone: 941-743-1027
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9 Mule Road
Rahway, New Jersey 07065
Principal Investigator: Sanjiv Sharma
Phone: 732-956-3944
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700 Spring Forest Road
Raleigh, North Carolina 27609
Principal Investigator: Richard Weisler, Dr
Phone: 919-872-5900
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1040 North Mason Road
Saint Louis, Missouri 63141
Principal Investigator: Siddharth Kaul
Phone: 636-220-1200
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Salt Lake City, Utah 84107
Principal Investigator: Michael Killpack
Phone: 801-288-0607
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729 Arapeen Drive
Salt Lake City, Utah 84108
Principal Investigator: Richard King
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San Antonio, Texas
Phone: 210-614-7483
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San Diego, California 92117
Principal Investigator: Bruce Lasker
Phone: 858-274-4226
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Sarasota, Florida 34243
Principal Investigator: Andrew Keegan
Phone: 941-256-8018
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Springfield, Illinois 62702
Principal Investigator: Thomas Ala
Phone: 217-545-7197
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Stuart, Florida 34997
Principal Investigator: Mark Brody
Phone: 561-374-8461
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766 Irving Avenue
Syracuse, New York 13210
Principal Investigator: Amy Sanders, Dr
Phone: 315-464-4243
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Tampa, Florida 33609
Principal Investigator: Kelley Yokum
Phone: 813-849-5566
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Tampa, Florida 33613
Principal Investigator: Amanda Smith
Phone: 813-396-0621
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Toms River, New Jersey 08755
Principal Investigator: Sanjiv Sharma
Phone: 732-341-9500
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Toms River, New Jersey 08755
Principal Investigator: Ashok Kantilal Patel
Phone: 732-244-2299
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Tucson, Arizona 85704
Principal Investigator: Jeanette Wendt
Phone: 520-742-1833
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Tulsa, Oklahoma 74104
Principal Investigator: Ralph Richter, MD
Phone: 918-743-2349
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Waukesha, Wisconsin 53188
Principal Investigator: Cary Kohlenberg
Phone: 262-513-0707
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West Long Branch, New Jersey 07764
Principal Investigator: Noah Gilson
Phone: 732-935-1850
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1001 North Minneapolis Street
Wichita, Kansas 67214
Principal Investigator: Matthew Macaluso
Phone: 316-293-2673
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923 Broadway
Woodmere, New York 11598
Principal Investigator: David Steiner
Phone: 516-239-1800
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