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CompletedNCT02580305Updated Jun 9, 2023Results posted

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

A Phase 2 interventional study of SUVN-502 and Placebo in Alzheimer's Disease, sponsored by Suven Life Sciences Limited. Completed at 71 sites in United States. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-06-09.

Sponsored by Suven Life Sciences Limited · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
564
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Alzheimer's Disease

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Keywords

  • SUVN-502
  • 5-HT6
  • Phase 2
  • Cognition
  • Donepezil
  • Memantine
  • Alzheimer's Disease
  • Triple Combination
  • Proof of Concept (POC)
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 564 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Suven Life Sciences Limited is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
564 participants (actual)

Study arms

  • Active comparator
    Experimental: SUVN-502 Low dose (50 mg)

    SUVN-502 Low dose adjunct to base treatment with Donepezil and Memantine

    Drug: SUVN-502 · Drug: Donepezil · Drug: Memantine

  • Active comparator
    Experimental: SUVN-502 High dose (100 mg)

    SUVN-502 High dose adjunct to base treatment with Donepezil and Memantine

    Drug: SUVN-502 · Drug: Donepezil · Drug: Memantine

  • Placebo comparator
    Placebo

    Placebo adjunct to base treatment with Donepezil and Memantine

    Drug: Placebo · Drug: Donepezil · Drug: Memantine

Interventions

  • DrugSUVN-502

    Once-daily, tablets, orally

    Also known as: Masupirdine

  • DrugPlacebo

    Once-daily, tablets, orally

  • DrugDonepezil

    Donepezil HCl (10 mg, once a day)

    Also known as: Namzaric

  • DrugMemantine

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

    Also known as: Namenda XR®

06

What researchers measure

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.

    Time frame: Baseline to Week 26

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline to Week 26

07

Results

Posted Jun 9, 2023

Participant flow

Study centers located in the United States of America (USA) participated in the study

Participant flow — Overall Study
MilestoneSUVN-502 Low Dose (50 mg)SUVN-502 High Dose (100 mg)Placebo
Started190185189
Safety population187181188
Modified intent-to-treat (mitt) population184176183
Completed147136157
Not completed434932
Withdrew: Adverse event151910
Withdrew: Lack of efficacy502
Withdrew: Protocol violation496
Withdrew: Lost to follow-up442
Withdrew: Withdrawal by subject1197
Withdrew: Randomized in error and never treated485

Outcome measures

PrimaryChange 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.

Time frame:
Baseline to Week 26
Reported as:
Least squares mean · score on a scale
Change From Baseline to Week-26 in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)
score on a scaleSUVN-502 Low Dose (50 mg)SUVN-502 High Dose (100 mg)Placebo
Change From Baseline to Week-26 in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)2.0 ± 0.52.5 ± 0.52.6 ± 0.5
Statistical analysis
  • SUVN-502 Low Dose (50 mg) vs Placebo · Mixed Models Analysis · p = 0.41 (Threshold for statistical significance was p≤0.05)Statistical Method: Mixed model for repeated measures
  • SUVN-502 High Dose (100 mg) vs Placebo · Mixed Models Analysis · p = 0.90 (Threshold for statistical significance was p≤0.05)Statistical Method: Mixed model for repeated measures
SecondaryChange 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.

Time frame:
Baseline to Week 26
Reported as:
Least squares mean · score on a scale
Change From Baseline to Week-26 in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
score on a scaleSUVN-502 Low Dose (50 mg)SUVN-502 High Dose (100 mg)Placebo
Change From Baseline to Week-26 in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)1.3 ± 0.21.0 ± 0.21.2 ± 0.2
Statistical analysis
  • SUVN-502 Low Dose (50 mg) vs Placebo · Mixed Models Analysis · p = 0.46 (Threshold for statistical significance was p≤0.05)Statistical Method: Mixed model for repeated measures
  • SUVN-502 High Dose (100 mg) vs Placebo · Mixed Models Analysis · p = 0.48 (Threshold for statistical significance was p≤0.05)Statistical Method: Mixed model for repeated measures
SecondaryChange 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.

Time frame:
Baseline to Week 26
Reported as:
Least squares mean · score on a scale
Change From Baseline to Week-26 in Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)
score on a scaleSUVN-502 Low Dose (50 mg)SUVN-502 High Dose (100 mg)Placebo
Change From Baseline to Week-26 in Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)-4.6 ± 0.6-3.4 ± 0.6-4.4 ± 0.6
Statistical analysis
  • SUVN-502 Low Dose (50 mg) vs Placebo · Mixed Models Analysis · p = 0.83 (Threshold for statistical significance was p≤0.05)Statistical Method: Mixed model for repeated measures
  • SUVN-502 High Dose (100 mg) vs Placebo · Mixed Models Analysis · p = 0.24 (Threshold for statistical significance was p≤0.05)Statistical Method: Mixed model for repeated measures
SecondaryChange 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.

Time frame:
Baseline to Week 26
Reported as:
Least squares mean · score on a scale
Change From Baseline to Week-26 in Neuropsychiatric Inventory (NPI)
score on a scaleSUVN-502 Low Dose (50 mg)SUVN-502 High Dose (100 mg)Placebo
Change From Baseline to Week-26 in Neuropsychiatric Inventory (NPI)0.5 ± 0.80.4 ± 0.92.1 ± 0.8
Statistical analysis
  • SUVN-502 Low Dose (50 mg) vs Placebo · Mixed Models Analysis · p = 0.17 (Threshold for statistical significance was p≤0.05)Statistical Method: Mixed model for repeated measures
  • SUVN-502 High Dose (100 mg) vs Placebo · Mixed Models Analysis · p = 0.14 (Threshold for statistical significance was p≤0.05)Statistical Method: Mixed model for repeated measures
SecondaryChange 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.

Time frame:
Baseline to Week 26
Reported as:
Least squares mean · score on a scale
Change From Baseline to Week-26 in Change in Mini Mental State Examination (MMSE)
score on a scaleSUVN-502 Low Dose (50 mg)SUVN-502 High Dose (100 mg)Placebo
Change From Baseline to Week-26 in Change in Mini Mental State Examination (MMSE)-1.1 ± 0.3-1.1 ± 0.3-1.0 ± 0.3
Statistical analysis
  • SUVN-502 Low Dose (50 mg) vs Placebo · Mixed Models Analysis · p = 0.79 (Threshold for statistical significance was p≤0.05)Statistical Method: Mixed model for repeated measures
  • SUVN-502 High Dose (100 mg) vs Placebo · Mixed Models Analysis · p = 0.92 (Threshold for statistical significance was p≤0.05)Statistical Method: Mixed model for repeated measures

Adverse events

Collected over 26 Weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SUVN-502 Low Dose (50 mg)3/187 (1.6%)10/187 (5.3%)50/187 (26.7%)
SUVN-502 High Dose (100 mg)2/181 (1.1%)14/181 (7.7%)44/181 (24.3%)
Placebo1/188 (0.5%)12/188 (6.4%)40/188 (21.3%)
Most frequent serious events
Showing 10 of 41
Most frequent serious events
EventSUVN-502 Low Dose (50 mg)SUVN-502 High Dose (100 mg)Placebo
SyncopeNervous system disorders3/1871/1810/188
PneumoniaInfections and infestations0/1872/1812/188
Acute kidney injuryRenal and urinary disorders0/1872/1810/188
DehydrationMetabolism and nutrition disorders2/1870/1810/188
SepsisInfections and infestations0/1871/1812/188
Urinary tract infectionInfections and infestations0/1871/1810/188
UrosepsisInfections and infestations0/1871/1810/188
Haemorrhage intracranialNervous system disorders0/1871/1810/188
Acute myocardial infarctionCardiac disorders0/1871/1810/188
BradycardiaCardiac disorders0/1871/1810/188
Most frequent other events
Most frequent other events
EventSUVN-502 Low Dose (50 mg)SUVN-502 High Dose (100 mg)Placebo
Urinary tract infectionInfections and infestations15/18721/18119/188
HeadacheNervous system disorders12/1874/1817/188
DiarrhoeaGastrointestinal disorders12/1879/1813/188
FallInjury, poisoning and procedural complications11/18710/18111/188

Baseline characteristics

A total of 564 patients were randomized as per the planned ratio to receive masupirdine 50 mg (190 patients), masupirdine 100 mg (185 patients), or placebo (189 patients). A total of 543 (96.3%) patients who were randomized to specific treatment sequence were included in the modified intent to treat (mITT) population and this mITT population is considered for baseline analysis.

Age, Continuous
Age, Continuous(years)SUVN-502 Low Dose (50 mg)SUVN-502 High Dose (100 mg)PlaceboTotal
Mean73.4 ± 8.0874.4 ± 6.9772.9 ± 7.2373.6 ± 7.46
Age, Customized
Age, Customized(Participants)SUVN-502 Low Dose (50 mg)SUVN-502 High Dose (100 mg)PlaceboTotal
Age group greater than or equal to 65 years159155157471
Sex: Female, Male
Sex: Female, Male(Participants)SUVN-502 Low Dose (50 mg)SUVN-502 High Dose (100 mg)PlaceboTotal
Female9596106297
Male898077246
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SUVN-502 Low Dose (50 mg)SUVN-502 High Dose (100 mg)PlaceboTotal
American Indian or Alaska Native1203
Asian3115
Native Hawaiian or Other Pacific Islander0101
Black or African American681024
White171162168501
More than one race3249
Unknown or Not Reported0000
APO-E4 Carrier Status
APO-E4 Carrier Status(Participants)SUVN-502 Low Dose (50 mg)SUVN-502 High Dose (100 mg)PlaceboTotal
Carrier one allele777984240
Carrier two allele24313590
Mini-Mental State Examination
Mini-Mental State Examination(units on a scale)SUVN-502 Low Dose (50 mg)SUVN-502 High Dose (100 mg)PlaceboTotal
Mean16.9 ± 2.2117.0 ± 2.4716.5 ± 2.4816.8 ± 2.39
08

Study locations

71 sites
  • 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
    Saint 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
09

References and documents

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 ↗

Study documents

  • Study protocol · Mar 2, 2016
  • Statistical analysis plan · Oct 31, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02580305
Lead sponsor
Suven Life Sciences Limited
Responsible party
Sponsor
First posted
Oct 20, 2015
Start date
Sep 2015
Primary completion
Nov 5, 2019
Completion
Nov 7, 2019
Results posted
Jun 9, 2023
Last update
Jun 9, 2023

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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