SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study
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
1 other identifier
interventional
564
1 country
71
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2015
Typical duration for phase_2
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 17, 2015
CompletedFirst Posted
Study publicly available on registry
October 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2019
CompletedResults Posted
Study results publicly available
June 9, 2023
CompletedJune 9, 2023
May 1, 2023
4.2 years
October 17, 2015
April 17, 2023
May 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week-26 in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)
Mean change from baseline at week 26 is assessed for ADAS-Cog11 score. The ADAS-Cog11 is a structured scale that evaluates memory, orientation, attention, reasoning, language, and constructional praxis. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in AD: word recall; commands; constructional praxis; naming objects and fingers; ideational praxis; orientation; word recognition; remembering test instructions; spoken language ability; word-finding difficulty; and comprehension of spoken language. The scale ranges from 0 to 70, with higher scores indicate greater impairment.
Baseline to Week 26
Secondary Outcomes (4)
Change From Baseline to Week-26 in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
Baseline to Week 26
Change From Baseline to Week-26 in Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)
Baseline to Week 26
Change From Baseline to Week-26 in Neuropsychiatric Inventory (NPI)
Baseline to Week 26
Change From Baseline to Week-26 in Change in Mini Mental State Examination (MMSE)
Baseline to Week 26
Study Arms (3)
Experimental: SUVN-502 Low dose (50 mg)
ACTIVE COMPARATORSUVN-502 Low dose adjunct to base treatment with Donepezil and Memantine
Experimental: SUVN-502 High dose (100 mg)
ACTIVE COMPARATORSUVN-502 High dose adjunct to base treatment with Donepezil and Memantine
Placebo
PLACEBO COMPARATORPlacebo adjunct to base treatment with Donepezil and Memantine
Interventions
Once-daily, tablets, orally
Donepezil HCl (10 mg, once a day)
Memantine HCl (10 mg, twice a day or 28 mg extended-release, once a day).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
Territory Neurology & Research Institute
Tucson, Arizona, 85704, United States
ATP Clinical Research, Inc.
Costa Mesa, California, 92626, United States
Neuro-Pain Medical Center Inc
Fresno, California, 93710, United States
Neurology Center of North Orange County
Fullerton, California, 72835, United States
Senior Clinical Trials, Inc.
Laguna Hills, California, 92653, United States
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806, United States
Easton Center for Alzheimer's Disease Research at UCLA
Los Angeles, California, 90095, United States
Paradigm Research
San Diego, California, 92117, United States
Associated Neurologists of South Connecticut
Fairfield, Connecticut, 06824, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
Bradenton Research Center, Inc
Bradenton, Florida, 34205, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
CCM Clinical Research Group
Miami, Florida, 33186, United States
Collier Neurologic Specialists
Naples, Florida, 34102, United States
Palm Beach Neurological Center
Palm Beach Gardens, Florida, 33410, United States
Anchor Neuroscience
Pensacola, Florida, 32502, United States
Emerald Coast Center for Neurological Disorders
Pensacola, Florida, 32514, United States
Neurostudies Inc
Port Charlotte, Florida, 33952, United States
The Roskamp Institute, Inc.
Sarasota, Florida, 34243, United States
Brain Matters Research
Stuart, Florida, 34997, United States
Neurology Clinical Research, Inc.
Sunrise, Florida, 33351, United States
Axiom Clinical Research of Florida
Tampa, Florida, 33609, United States
Olympian Clinical Research
Tampa, Florida, 33609, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
University of South Florida - Byrd Alzheimer's Institute
Tampa, Florida, 33613, United States
iResearch Atlanta, LLC
Decatur, Georgia, 30030, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Southern Illinois School of Medicine
Springfield, Illinois, 62702, United States
Indiana University Health - University Hospital
Indianapolis, Indiana, 46202, United States
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, 66606, United States
KU Medical Center Wichita Clinical Trial Unit
Wichita, Kansas, 67214, United States
University Of Kentucky
Lexington, Kentucky, 40536, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
Acadia Hospital
Bangor, Maine, 04402, United States
Sheppard Pratt Health System
Baltimore, Maryland, 21204, United States
Clinical Research Professionals
St Louis, Missouri, 63141, United States
Princeton Medical Institute
Princeton, New Jersey, 08540, United States
Advanced Memory Research Institute of NJ, PC - Internal Medicine
Rahway, New Jersey, 07065, United States
Advanced Memory Research Institute
Toms River, New Jersey, 08755, United States
Biobehavioral Health
Toms River, New Jersey, 08755, United States
Neurology Specialists of Monmouth County
West Long Branch, New Jersey, 07764, United States
Neurological Associates of Albany, PC
Albany, New York, 12208, United States
Integrative Clinical Trials, LLC
Brooklyn, New York, 11229, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235, United States
Mid Hudson Medical Research
New Windsor, New York, 12553, United States
New York University
New York, New York, 10016, United States
Eastside Comprehensive Medical Center, LLC
New York, New York, 10021, United States
Manhattan Behavioral Medicine
New York, New York, 10022, United States
Upstate University Hospital (SUNY Health Science Center)
Syracuse, New York, 13210, United States
Five Towns Neuroscience Research
Woodmere, New York, 11598, United States
New Hope Clinical Research
Charlotte, North Carolina, 28211, United States
Alzheimer Memory Center
Charlotte, North Carolina, 28270, United States
Richard Weisler, MD, PA
Raleigh, North Carolina, 27609, United States
Ohio Clinical Research Partners, LLC
Canton, Ohio, 44718, United States
Valley Medical Research
Centerville, Ohio, 45459, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, 74104, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
Northeastern Pennsylvania Memory and Alzheimers Center
Plains, Pennsylvania, 18705, United States
Roper St. Francis Healthcare
Charleston, South Carolina, 29401, United States
University of North Texas Health Science Center
Fort Worth, Texas, 76107, United States
Shepherd Healthcare
Lewisville, Texas, 75067, United States
Radiant Research, Inc.
San Antonio, Texas, 78229, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
Center for Alzheimer's Care, Imaging and Research
Salt Lake City, Utah, 84108, United States
Independent Psychiatric Consultants, SC, dba
Waukesha, Wisconsin, 53188, United States
Related Publications (3)
Nirogi R, Jayarajan P, Benade V, Shinde A, Goyal VK, Jetta S, Ravula J, Abraham R, Grandhi VR, Subramanian R, Pandey SK, Badange RK, Mohammed AR, Jasti V, Ballard C, Cummings J. Potential beneficial effects of masupirdine (SUVN-502) on agitation/aggression and psychosis in patients with moderate Alzheimer's disease: Exploratory post hoc analyses. Int J Geriatr Psychiatry. 2022 Oct;37(10):10.1002/gps.5813. doi: 10.1002/gps.5813.
PMID: 36168659RESULTNirogi R, Ieni J, Goyal VK, Ravula J, Jetta S, Shinde A, Jayarajan P, Benade V, Palacharla VRC, Dogiparti DK, Jasti V, Atri A, Cummings J. Effect of masupirdine (SUVN-502) on cognition in patients with moderate Alzheimer's disease: A randomized, double-blind, phase 2, proof-of-concept study. Alzheimers Dement (N Y). 2022 Jun 1;8(1):e12307. doi: 10.1002/trc2.12307. eCollection 2022.
PMID: 35662833RESULTNirogi R, Goyal VK, Benade V, Subramanian R, Ravula J, Jetta S, Shinde A, Pandey SK, Jayarajan P, Jasti V, Cummings J. Effect of Concurrent Use of Memantine on the Efficacy of Masupirdine (SUVN-502): A Post Hoc Analysis of a Phase 2 Randomized Placebo-Controlled Study. Neurol Ther. 2022 Dec;11(4):1583-1594. doi: 10.1007/s40120-022-00390-4. Epub 2022 Jul 31.
PMID: 35908254RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ramakrishna Nirogi, PhD
- Organization
- Suven Life Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2015
First Posted
October 20, 2015
Study Start
September 1, 2015
Primary Completion
November 5, 2019
Study Completion
November 7, 2019
Last Updated
June 9, 2023
Results First Posted
June 9, 2023
Record last verified: 2023-05