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
sites
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
Phone: 850-433-6760
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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
Phone: 855-447-3012
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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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Princeton, New Jersey 08540
Principal Investigator: Jeffrey Apter
Phone: 609-921-3555
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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
Phone: 801-581-3986
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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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