Last updated on June 2018

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


Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT02580305

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William Burke

Banner Alzheimer's Institute
Phoenix, AZ United States
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Marwan Sabbagh

Barrow Neurological Institute
Phoenix, AZ United States
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Jeanette Wendt

Territory Neurology & Research Institute
Tucson, AZ United States
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Gustavo Alva

ATP Clinical Research, Inc.
Costa Mesa, CA United States
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Perminder Bhatia

Neuro-Pain Medical Center Inc
Fresno, CA United States
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Robert Feldman

Senior Clinical Trials, Inc.
Laguna Hills, CA United States
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Omid Omidvar

Collaborative Neuroscience Network, LLC
Long Beach, CA United States
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Bruce Lasker

Paradigm Research
San Diego, CA United States
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Srinath Kadimi

Associated Neurologists of South Connecticut
Fairfield, CT United States
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Mark Goldstein

JEM Research Institute
Atlantis, FL United States
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William McElveen

Bradenton Research Center, Inc
Bradenton, FL United States
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Mark Brody

Brain Matters Research
Delray Beach, FL United States
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Erin Doty

Jacksonville Center for Clinical Research
Jacksonville, FL United States
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Francisco Ricart

CCM Clinical Research Group
Miami, FL United States
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William Justiz

Collier Neurologic Specialists
Naples, FL United States
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Michael Tuchman

Palm Beach Neurological Center
Palm Beach Gardens, FL United States
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Liliana Montoya

Neurostudies Inc
Port Charlotte, FL United States
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Andrew Keegan

The Roskamp Institute, Inc.
Sarasota, FL United States
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Richard Singer

Neurology Clinical Research, Inc.
Sunrise, FL United States
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Ruth Cox

Axiom Clinical Research of Florida
Tampa, FL United States
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Kelley Yokum

Olympian Clinical Research
Tampa, FL United States
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Ashley Peterson

Stedman Clinical Trials
Tampa, FL United States
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Amanda Smith

University of South Florida - Byrd Alzheimer's Institute
Tampa, FL United States
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Kimball Johnson, Dr

iResearch Atlanta, LLC
Decatur, GA United States
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Darren Gitelman

Advocate Lutheran General Hospital
Park Ridge, IL United States
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Thomas Ala

Southern Illinois School of Medicine
Springfield, IL United States
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Martin Farlow

Indiana University Health - University Hospital
Indianapolis, IN United States
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Gregory Jicha

University Of Kentucky
Lexington, KY United States
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Jeffrey Keller

Pennington Biomedical Research Center
Baton Rouge, LA United States
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Clifford Singer

Acadia Hospital
Bangor, ME United States
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Scott Aaronson

Sheppard Pratt Health System
Baltimore, MD United States
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Jeffrey Apter

Princeton Medical Institute
Princeton, NJ United States
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Sanjiv Sharma

Advanced Memory Research Institute
Toms River, NJ United States
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Ashok Kantilal Patel

Biobehavioral Health
Toms River, NJ United States
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Noah Gilson

Neurology Specialists of Monmouth County
West Long Branch, NJ United States
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Inna Yuryev-Golger

Integrative Clinical Trials, LLC
Brooklyn, NY United States
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Nick Vatakis

SPRI Clinical Trials, LLC
Brooklyn, NY United States
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Sashi Makam

Mid Hudson Medical Research
New Windsor, NY United States
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Martin Sadowski

New York University
New York, NY United States
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Ram Shrivastava

Eastside Comprehensive Medical Center, LLC
New York, NY United States
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Judith Joseph

Manhattan Behavioral Medicine
New York, NY United States
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Amy Sanders, Dr

Upstate University Hospital (SUNY Health Science Center)
Syracuse, NY United States
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Santosh Gopalakrishnan

New Hope Clinical Research
Charlotte, NC United States
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Mohammad Bolouri

Alzheimer Memory Center
Charlotte, NC United States
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Richard Weisler, Dr

Richard Weisler, MD, PA
Raleigh, NC United States
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Ryan Drake

Ohio Clinical Research Partners, LLC
Canton, OH United States
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Meenakshi Patel

Valley Medical Research
Centerville, OH United States
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Louise Thurman

IPS Research Company
Oklahoma City, OK United States
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Carl Griffin

Lynn Health Science Institute
Oklahoma City, OK United States
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Ralph Richter, MD

Tulsa Clinical Research, LLC
Tulsa, OK United States
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Lorraine Spikol

Lehigh Valley Health Network
Allentown, PA United States
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Mario Cornacchione

Northeastern Pennsylvania Memory and Alzheimers Center
Plains, PA United States
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Jacobo Mintzer

Roper St. Francis Healthcare
Charleston, SC United States
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Timothy Shepherd

Shepherd Healthcare
Lewisville, TX United States
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Teri-Lynn Fielder

Radiant Research, Inc.
San Antonio, TX United States
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Michael Killpack

Wasatch Clinical Research
Salt Lake City, UT United States
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Richard King

Center for Alzheimer's Care, Imaging and Research
Salt Lake City, UT United States
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Cary Kohlenberg

Independent Psychiatric Consultants, SC, dba
Waukesha, WI United States
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Anthony Ciabarra

Neurology Center of North Orange County
Fullerton, CA United States
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Matthew Macaluso

KU Medical Center Wichita Clinical Trial Unit
Wichita, KS United States
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Sanjiv Sharma

Advanced Memory Research Institute of NJ, PC - Internal Medicine
Rahway, NJ United States
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Richard Holub

Neurological Associates of Albany, PC
Albany, NY United States
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David Steiner

Five Towns Neuroscience Research
Woodmere, NY United States
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Sarah Kremen, Dr

Easton Center for Alzheimer's Disease Research at UCLA
Los Angeles, CA United States
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David Bear, Dr

Emerald Coast Center for Neurological Disorders
Pensacola, FL United States
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Scott Teeter

Cotton-O'Neil Clinical Research Center
Topeka, KS United States
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Siddharth Kaul

Clinical Research Professionals
Saint Louis, MO United States
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Janice Knebl

University of North Texas Health Science Center
Fort Worth, TX United States
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Kevin Groom

Anchor Neuroscience
Pensacola, FL United States
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