Last updated on November 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

Contact Investigators or Research Sites near you

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William Burke

Banner Alzheimer's Institute
Phoenix, AZ United States

Marwan Sabbagh

Barrow Neurological Institute
Phoenix, AZ United States

Jeanette Wendt

Territory Neurology & Research Institute
Tucson, AZ United States

Gustavo Alva

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

Perminder Bhatia

Neuro-Pain Medical Center Inc
Fresno, CA United States

Robert Feldman

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

Omid Omidvar

Collaborative Neuroscience Network, LLC
Long Beach, CA United States

Bruce Lasker

Paradigm Research
San Diego, CA United States

Srinath Kadimi

Associated Neurologists of South Connecticut
Fairfield, CT United States

Mark Goldstein

JEM Research Institute
Atlantis, FL United States

William McElveen

Bradenton Research Center, Inc
Bradenton, FL United States

Mark Brody

Brain Matters Research
Delray Beach, FL United States

Erin Doty

Jacksonville Center for Clinical Research
Jacksonville, FL United States

Francisco Ricart

CCM Clinical Research Group
Miami, FL United States

William Justiz

Collier Neurologic Specialists
Naples, FL United States

Michael Tuchman

Palm Beach Neurological Center
Palm Beach Gardens, FL United States

Liliana Montoya

Neurostudies Inc
Port Charlotte, FL United States

Andrew Keegan

The Roskamp Institute, Inc.
Sarasota, FL United States

Richard Singer

Neurology Clinical Research, Inc.
Sunrise, FL United States

Ruth Cox

Axiom Clinical Research of Florida
Tampa, FL United States

Kelley Yokum

Olympian Clinical Research
Tampa, FL United States

Ashley Peterson

Stedman Clinical Trials
Tampa, FL United States

Amanda Smith

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

Kimball Johnson, Dr

iResearch Atlanta, LLC
Decatur, GA United States

Darren Gitelman

Advocate Lutheran General Hospital
Park Ridge, IL United States

Thomas Ala

Southern Illinois School of Medicine
Springfield, IL United States

Martin Farlow

Indiana University Health - University Hospital
Indianapolis, IN United States

Gregory Jicha

University Of Kentucky
Lexington, KY United States

Jeffrey Keller

Pennington Biomedical Research Center
Baton Rouge, LA United States

Clifford Singer

Acadia Hospital
Bangor, ME United States

Scott Aaronson

Sheppard Pratt Health System
Baltimore, MD United States

Jeffrey Apter

Princeton Medical Institute
Princeton, NJ United States

Sanjiv Sharma

Advanced Memory Research Institute
Toms River, NJ United States

Ashok Kantilal Patel

Biobehavioral Health
Toms River, NJ United States

Noah Gilson

Neurology Specialists of Monmouth County
West Long Branch, NJ United States

Inna Yuryev-Golger

Integrative Clinical Trials, LLC
Brooklyn, NY United States

Nick Vatakis

SPRI Clinical Trials, LLC
Brooklyn, NY United States

Sashi Makam

Mid Hudson Medical Research
New Windsor, NY United States

Martin Sadowski

New York University
New York, NY United States

Ram Shrivastava

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

Judith Joseph

Manhattan Behavioral Medicine
New York, NY United States

Amy Sanders, Dr

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

Santosh Gopalakrishnan

New Hope Clinical Research
Charlotte, NC United States

Mohammad Bolouri

Alzheimer Memory Center
Charlotte, NC United States

Richard Weisler, Dr

Richard Weisler, MD, PA
Raleigh, NC United States

Ryan Drake

Ohio Clinical Research Partners, LLC
Canton, OH United States

Meenakshi Patel

Valley Medical Research
Centerville, OH United States

Louise Thurman

IPS Research Company
Oklahoma City, OK United States

Carl Griffin

Lynn Health Science Institute
Oklahoma City, OK United States

Ralph Richter, MD

Tulsa Clinical Research, LLC
Tulsa, OK United States

Lorraine Spikol

Lehigh Valley Health Network
Allentown, PA United States

Mario Cornacchione

Northeastern Pennsylvania Memory and Alzheimers Center
Plains, PA United States

Jacobo Mintzer

Roper St. Francis Healthcare
Charleston, SC United States

Timothy Shepherd

Shepherd Healthcare
Lewisville, TX United States

Teri-Lynn Fielder

Radiant Research, Inc.
San Antonio, TX United States

Michael Killpack

Wasatch Clinical Research
Salt Lake City, UT United States

Richard King

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

Cary Kohlenberg

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

Anthony Ciabarra

Neurology Center of North Orange County
Fullerton, CA United States

Matthew Macaluso

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

Sanjiv Sharma

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

Richard Holub

Neurological Associates of Albany, PC
Albany, NY United States

David Steiner

Five Towns Neuroscience Research
Woodmere, NY United States

Sarah Kremen, Dr

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

David Bear, Dr

Emerald Coast Center for Neurological Disorders
Pensacola, FL United States

Scott Teeter

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

Siddharth Kaul

Clinical Research Professionals
Saint Louis, MO United States

Janice Knebl

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

Kevin Groom

Anchor Neuroscience
Pensacola, FL United States

Kasia Gustaw Rothenberg, Dr

Cleveland Clinic Main Campus
Cleveland, OH United States

Mark Brody

Brain Matters Research
Stuart, FL United States