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

Status: Completed
Location: See all (71) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:

• Has a diagnosis of probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (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.

Locations
United States
Arizona
Banner Alzheimer's Institute
Phoenix
Barrow Neurological Institute
Phoenix
Territory Neurology & Research Institute
Tucson
California
ATP Clinical Research, Inc.
Costa Mesa
Neuro-Pain Medical Center Inc
Fresno
Neurology Center of North Orange County
Fullerton
Senior Clinical Trials, Inc.
Laguna Hills
Collaborative Neuroscience Network, LLC
Long Beach
Easton Center for Alzheimer's Disease Research at UCLA
Los Angeles
Paradigm Research
San Diego
Connecticut
Associated Neurologists of South Connecticut
Fairfield
Florida
JEM Research Institute
Atlantis
Bradenton Research Center, Inc
Bradenton
Brain Matters Research
Delray Beach
Jacksonville Center for Clinical Research
Jacksonville
CCM Clinical Research Group
Miami
Collier Neurologic Specialists
Naples
Palm Beach Neurological Center
Palm Beach Gardens
Anchor Neuroscience
Pensacola
Emerald Coast Center for Neurological Disorders
Pensacola
Neurostudies Inc
Port Charlotte
The Roskamp Institute, Inc.
Sarasota
Brain Matters Research
Stuart
Neurology Clinical Research, Inc.
Sunrise
Axiom Clinical Research of Florida
Tampa
Olympian Clinical Research
Tampa
Stedman Clinical Trials
Tampa
University of South Florida - Byrd Alzheimer's Institute
Tampa
Georgia
iResearch Atlanta, LLC
Decatur
Illinois
Advocate Lutheran General Hospital
Park Ridge
Southern Illinois School of Medicine
Springfield
Indiana
Indiana University Health - University Hospital
Indianapolis
Kansas
Cotton-O'Neil Clinical Research Center
Topeka
KU Medical Center Wichita Clinical Trial Unit
Wichita
Kentucky
University Of Kentucky
Lexington
Louisiana
Pennington Biomedical Research Center
Baton Rouge
Maryland
Sheppard Pratt Health System
Baltimore
Maine
Acadia Hospital
Bangor
Missouri
Clinical Research Professionals
Saint Louis
North Carolina
Alzheimer Memory Center
Charlotte
New Hope Clinical Research
Charlotte
Richard Weisler, MD, PA
Raleigh
New Jersey
Princeton Medical Institute
Princeton
Advanced Memory Research Institute of NJ, PC - Internal Medicine
Rahway
Advanced Memory Research Institute
Toms River
Biobehavioral Health
Toms River
Neurology Specialists of Monmouth County
West Long Branch
New York
Neurological Associates of Albany, PC
Albany
Integrative Clinical Trials, LLC
Brooklyn
SPRI Clinical Trials, LLC
Brooklyn
Mid Hudson Medical Research
New Windsor
Eastside Comprehensive Medical Center, LLC
New York
Manhattan Behavioral Medicine
New York
New York University
New York
Upstate University Hospital (SUNY Health Science Center)
Syracuse
Five Towns Neuroscience Research
Woodmere
Ohio
Ohio Clinical Research Partners, LLC
Canton
Valley Medical Research
Centerville
Cleveland Clinic Main Campus
Cleveland
Oklahoma
IPS Research Company
Oklahoma City
Lynn Health Science Institute
Oklahoma City
Tulsa Clinical Research, LLC
Tulsa
Pennsylvania
Lehigh Valley Health Network
Allentown
Northeastern Pennsylvania Memory and Alzheimers Center
Plains
South Carolina
Roper St. Francis Healthcare
Charleston
Texas
University of North Texas Health Science Center
Fort Worth
Shepherd Healthcare
Lewisville
Radiant Research, Inc.
San Antonio
Utah
Center for Alzheimer's Care, Imaging and Research
Salt Lake City
Wasatch Clinical Research
Salt Lake City
Wisconsin
Independent Psychiatric Consultants, SC, dba
Waukesha
Time Frame
Start Date: 2015-09
Completion Date: 2019-11-07
Participants
Target number of participants: 564
Treatments
Active_comparator: Experimental: SUVN-502 Low dose (50 mg)
SUVN-502 Low dose adjunct to base treatment with Donepezil and Memantine
Active_comparator: Experimental: SUVN-502 High dose (100 mg)
SUVN-502 High dose adjunct to base treatment with Donepezil and Memantine
Placebo_comparator: Placebo
Placebo adjunct to base treatment with Donepezil and Memantine
Authors
Singararelu Jagadeesan, Darren Gitelman, Jared Brosch, Cary Kohlenberg, Omar Suarez, Sheldon Preskorn, William Justiz, Richard Holub, Jagan Pillai, Kendrick Henderson, Lynn Eckert, Nima Ramezan-Arab, Dario Zagar, Christina Mayville, Lihong Shen, Gustavo Alva, Judith Kirstein, Michael Killpack, Rajagopal Sunder, Marcia Meiring, Crystal Watkins, William Jennings, William McElveen, William Burke, Kelley Yokum, Deborah Burke, Carl Griffin, Amy Sanders, Manish Saini, Bruce Lasker, Dragos Mihaila, John Beyer, Bruce Kohrman, Lorraine Spikol, Julie Baker, Judith Joseph, Kamran Tasharofi, Sarah Kremen, Matthews Gwynn, Sanjiv Sharma, Alpa Patel, Ashok Kantilal Patel, James Goldenberg, Perminder Bhatia, Ram Shrivastava, Scott Aaronson, Michael Tuchman, Scott Teeter, Annliza Piacitelli, Timothy Jennings, Susan Thompson, Maria Santiago, Alan Cohen, Janice Knebl, Michael Rossen, Paul Grumley, Jeffrey Apter, Benny Barnhart, Steven Reynolds, Thomas Toothaker, Kimball Johnson, Lee Stein, Gianni Faedda, Darlene Bartilucci, Stephen Sergay, Erin Doty, Steven Smith, Hitesh Patel, Olga Brawman-Mintzer, Martin Farlow, Melanie Shulman, Barbara O'Brien, Jorge Caso, Alexander Bystritsky, Gregory Jicha, Babak Tousi, Richard Weisler, Michael Yuryev, Edward Zamrini, Timothy Grant, Michelle Craig, Marwan Sabbagh, Thomas Wisniewski, Padmaja Gayam, Mark Leibowitz, Ryan Drake, Barry Cutler, Omid Omidvar, Gary Boone, Mario Cornacchione, Giovanni Geronilla, Jeanette Wendt, Jeffry Jacqmein, Noah Gilson, Carolyn Tran, Matthew Macaluso, Siddharth Kaul, Thomas Ala, Sashi Makam, Santosh Gopalakrishnan, Anthony Ciabarra, Eugene Dagon, Emilio Mantero-Atienza, Clifford Singer, Richard King, Anna Long, William Simpson, Wayne Rubinstein, Gurjeet Kahlon, Mark Brody, David Steiner, Jose Cardona, Balebail Ashok Raj, Ronald Warnell, Mark Goldstein, Thomas Wade, Jeffrey Gross, Beth Ridgway, Tien Vo, Sunil-Kumar Reddy, James Wood, David Bear, Dennis Lacey, Mark Cascione, Alejandro Alva, Jacobo Mintzer, Maryam Beigi, Miroslav Gavazov, Mikhail Pilman, Mohammad Bolouri, Liliana Montoya, Kasia Gustaw Rothenberg, Zinoviy Benzar, Meenakshi Patel, Nicholas Blondin, Andrew Keegan, Srinath Kadimi, Luis Veras, Mrunalini Gaikwad, Louise Thurman, Zachary Hansen
Related Therapeutic Areas
Sponsors
Leads: Suven Life Sciences Limited

This content was sourced from clinicaltrials.gov

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