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Alzheimer's DiseasePhase 2NCT02580305

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

A Phase 2 study testing SUVN-502, Donepezil and Memantine in people with Alzheimer's Disease, run by Suven Life Sciences Limited at 71 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
SUVN-502, Donepezil and Memantine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
564 participants
Where
71 sitesUnited States
Study dates
Sep 2015to 7 Nov 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

71 sites in 1 country.

71 sites in 1 country

United States71 sites

  • Neurological Associates of Albany, PC

    Albany, New York, 12208

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Sheppard Pratt Health System

    Baltimore, Maryland, 21204

  • Acadia Hospital

    Bangor, Maine, 04402

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

  • Bradenton Research Center, Inc

    Bradenton, Florida, 34205

  • Integrative Clinical Trials, LLC

    Brooklyn, New York, 11229

  • SPRI Clinical Trials, LLC

    Brooklyn, New York, 11235

  • Ohio Clinical Research Partners, LLC

    Canton, Ohio, 44718

  • Valley Medical Research

    Centerville, Ohio, 45459

  • Roper St. Francis Healthcare

    Charleston, South Carolina, 29401

  • New Hope Clinical Research

    Charlotte, North Carolina, 28211

  • Alzheimer Memory Center

    Charlotte, North Carolina, 28270

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195

  • ATP Clinical Research, Inc.

    Costa Mesa, California, 92626

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Associated Neurologists of South Connecticut

    Fairfield, Connecticut, 06824

  • University of North Texas Health Science Center

    Fort Worth, Texas, 76107

  • Neuro-Pain Medical Center Inc

    Fresno, California, 93710

  • Neurology Center of North Orange County

    Fullerton, California, 72835

  • Indiana University Health - University Hospital

    Indianapolis, Indiana, 46202

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Senior Clinical Trials, Inc.

    Laguna Hills, California, 92653

  • Shepherd Healthcare

    Lewisville, Texas, 75067

  • University Of Kentucky

    Lexington, Kentucky, 40536

  • Collaborative Neuroscience Network, LLC

    Long Beach, California, 90806

  • Easton Center for Alzheimer's Disease Research at UCLA

    Los Angeles, California, 90095

  • CCM Clinical Research Group

    Miami, Florida, 33186

  • Collier Neurologic Specialists

    Naples, Florida, 34102

  • Mid Hudson Medical Research

    New Windsor, New York, 12553

  • New York University

    New York, New York, 10016

  • Eastside Comprehensive Medical Center, LLC

    New York, New York, 10021

  • Manhattan Behavioral Medicine

    New York, New York, 10022

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Palm Beach Neurological Center

    Palm Beach Gardens, Florida, 33410

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

  • Anchor Neuroscience

    Pensacola, Florida, 32502

  • Emerald Coast Center for Neurological Disorders

    Pensacola, Florida, 32514

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Northeastern Pennsylvania Memory and Alzheimers Center

    Plains, Pennsylvania, 18705

  • Neurostudies Inc

    Port Charlotte, Florida, 33952

  • Princeton Medical Institute

    Princeton, New Jersey, 08540

  • Advanced Memory Research Institute of NJ, PC - Internal Medicine

    Rahway, New Jersey, 07065

  • Richard Weisler, MD, PA

    Raleigh, North Carolina, 27609

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107

  • Center for Alzheimer's Care, Imaging and Research

    Salt Lake City, Utah, 84108

  • Radiant Research, Inc.

    San Antonio, Texas, 78229

  • Paradigm Research

    San Diego, California, 92117

  • The Roskamp Institute, Inc.

    Sarasota, Florida, 34243

  • Southern Illinois School of Medicine

    Springfield, Illinois, 62702

  • Clinical Research Professionals

    St Louis, Missouri, 63141

  • Brain Matters Research

    Stuart, Florida, 34997

  • Neurology Clinical Research, Inc.

    Sunrise, Florida, 33351

  • Upstate University Hospital (SUNY Health Science Center)

    Syracuse, New York, 13210

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • Olympian Clinical Research

    Tampa, Florida, 33609

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • University of South Florida - Byrd Alzheimer's Institute

    Tampa, Florida, 33613

  • Advanced Memory Research Institute

    Toms River, New Jersey, 08755

  • Biobehavioral Health

    Toms River, New Jersey, 08755

  • Cotton-O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Territory Neurology & Research Institute

    Tucson, Arizona, 85704

  • Tulsa Clinical Research, LLC

    Tulsa, Oklahoma, 74104

  • Independent Psychiatric Consultants, SC, dba

    Waukesha, Wisconsin, 53188

  • Neurology Specialists of Monmouth County

    West Long Branch, New Jersey, 07764

  • KU Medical Center Wichita Clinical Trial Unit

    Wichita, Kansas, 67214

  • Five Towns Neuroscience Research

    Woodmere, New York, 11598

Other trials in United States

About this study

Official title: 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.

Read the detailed 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® (Extended Release, 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.

Being tested
SUVN-502, Placebo, Donepezil, Memantine
Keywords
SUVN-502, 5-HT6, Phase 2, Cognition, Donepezil, Memantine, Alzheimer's Disease, Triple Combination, Proof of Concept (POC)
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SUVN-502Drug

    Also called Masupirdine

    Once-daily, tablets, orally

  • PlaceboDrug

    Once-daily, tablets, orally

  • DonepezilDrug

    Also called Namzaric

    Donepezil HCl (10 mg, once a day)

  • MemantineDrug

    Also called Namenda XR®

    Memantine HCl (10 mg, twice a day or 28 mg extended-release, once a day).

Study groups in NCT02580305
Study groupRoleWhat they receive
Experimental: SUVN-502 Low dose (50 mg)Active comparatorSUVN-502 Low dose adjunct to base treatment with Donepezil and Memantine
Receives: Drug: SUVN-502; Drug: Donepezil; Drug: Memantine
Experimental: SUVN-502 High dose (100 mg)Active comparatorSUVN-502 High dose adjunct to base treatment with Donepezil and Memantine
Receives: Drug: SUVN-502; Drug: Donepezil; Drug: Memantine
PlaceboPlacebo comparatorPlacebo adjunct to base treatment with Donepezil and Memantine
Receives: Drug: Placebo; Drug: Donepezil; Drug: Memantine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 26

Secondary outcomes (4)

  1. Change From Baseline to Week-26 in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)

    Clinical Dementia Rating-Sum of Boxes (CDR-SB) - Sum of Boxes CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care.

    Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.

    Measured: Baseline to Week 26

  2. Change From Baseline to Week-26 in Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)

    The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory.

    The ADCS-ADL measures both basic and instrumental activities of daily living The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity.

    Measured: Baseline to Week 26

  3. Change From Baseline to Week-26 in Neuropsychiatric Inventory (NPI)

    Neuropsychiatric Inventory (NPI) 12 item - Total Score NPI assesses psychopathology in participants with dementia and other neurologic disorders.

    Total score ranges from 12 to 144; higher scores indicate greater disease severity.

    Measured: Baseline to Week 26

  4. Change From Baseline to Week-26 in Change in Mini Mental State Examination (MMSE)

    Change in Mini-Mental State Examination (MMSE) - Total Score Minimum Score - 0, Maximum Score - 30. Higher score means better outcome.

    Measured: Baseline to Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2015 (estimated)
  2. Study startSep 2015
  3. Primary completion5 Nov 2019
  4. Study completion7 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
564 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02580305
Sponsor's protocol ID
CTP2S1502HT6
Status last verified
May 2023
First submitted
17 Oct 2015
Last updated
9 Jun 2023
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36168659

  • Nirogi 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.

    PubMed 35662833

  • Nirogi 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.

    PubMed 35908254

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SUVN-502, Donepezil and Memantine in people with Alzheimer's Disease, run by Suven Life Sciences Limited at 71 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week-26 in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) (time frame: Baseline to Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02580305, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.

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