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

Sponsor
Suven Life Sciences Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT02580305
Collaborator
(none)
564
Enrollment
71
Locations
3
Arms
50.2
Duration (Months)
7.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
564 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Nov 5, 2019
Actual Study Completion Date :
Nov 7, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Experimental: SUVN-502 Low dose (50 mg)

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

Drug: SUVN-502
Once-daily, tablets, orally
Other Names:
  • Masupirdine

    • Drug: Donepezil
    Donepezil HCl (10 mg, once a day)
    Other Names:
  • Namzaric

    • Drug: Memantine
    Memantine HCl (10 mg, twice a day or 28 mg extended-release, once a day).
    Other Names:
  • Namenda XR®

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

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

    Drug: SUVN-502
    Once-daily, tablets, orally
    Other Names:
  • Masupirdine

    • Drug: Donepezil
    Donepezil HCl (10 mg, once a day)
    Other Names:
  • Namzaric

    • Drug: Memantine
    Memantine HCl (10 mg, twice a day or 28 mg extended-release, once a day).
    Other Names:
  • Namenda XR®

    		•
    Placebo Comparator: Placebo

    Placebo adjunct to base treatment with Donepezil and Memantine

    Drug: Placebo
    Once-daily, tablets, orally

    Drug: Donepezil
    Donepezil HCl (10 mg, once a day)
    Other Names:
  • Namzaric

    • Drug: Memantine
    Memantine HCl (10 mg, twice a day or 28 mg extended-release, once a day).
    Other Names:
  • Namenda XR®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in cognition [Screening, Baseline, Week 4, 13 and 26]

      Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAScog -11) total score

    Secondary Outcome Measures

    1. Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) [Baseline, Week 4, 13 and 26]

      Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)

    2. Change in functioning [Baseline, Week 4, 13 and 26]

      Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) total score

    3. Change in behavioural disturbance [Baseline, Week 4, 13 and 26]

      Neuropsychiatric Inventory (NPI) 12 item

    4. Depression and Dementia [Screening, Baseline, Week 4, 13. 26 and 30]

      Cornell Scale for Depression and Dementia (C-SDD)

    5. Risk of suicidality [Screening, Baseline, Week 4, 13. 26 and 30]

      Columbia Suicide Severity Rating Scale (C-SSRS)

    6. Change in cognitive aspects of mental function [Screening, Baseline, Week 4, 13 and 26]

      Change in Mini Mental State Examination (MMSE)

    7. Safety and tolerability [Up to 26 weeks and a 4-week safety follow up]

      Number of patients with adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    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:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner Alzheimer's Institute Phoenix Arizona United States 85006
    2 Barrow Neurological Institute Phoenix Arizona United States 85013
    3 Territory Neurology & Research Institute Tucson Arizona United States 85704
    4 ATP Clinical Research, Inc. Costa Mesa California United States 92626
    5 Neuro-Pain Medical Center Inc Fresno California United States 93710
    6 Neurology Center of North Orange County Fullerton California United States 72835
    7 Senior Clinical Trials, Inc. Laguna Hills California United States 92653
    8 Collaborative Neuroscience Network, LLC Long Beach California United States 90806
    9 Easton Center for Alzheimer's Disease Research at UCLA Los Angeles California United States 90095
    10 Paradigm Research San Diego California United States 92117
    11 Associated Neurologists of South Connecticut Fairfield Connecticut United States 06824
    12 JEM Research Institute Atlantis Florida United States 33462
    13 Bradenton Research Center, Inc Bradenton Florida United States 34205
    14 Brain Matters Research Delray Beach Florida United States 33445
    15 Jacksonville Center for Clinical Research Jacksonville Florida United States 32216
    16 CCM Clinical Research Group Miami Florida United States 33186
    17 Collier Neurologic Specialists Naples Florida United States 34102
    18 Palm Beach Neurological Center Palm Beach Gardens Florida United States 33410
    19 Anchor Neuroscience Pensacola Florida United States 32502
    20 Emerald Coast Center for Neurological Disorders Pensacola Florida United States 32514
    21 Neurostudies Inc Port Charlotte Florida United States 33952
    22 The Roskamp Institute, Inc. Sarasota Florida United States 34243
    23 Brain Matters Research Stuart Florida United States 34997
    24 Neurology Clinical Research, Inc. Sunrise Florida United States 33351
    25 Axiom Clinical Research of Florida Tampa Florida United States 33609
    26 Olympian Clinical Research Tampa Florida United States 33609
    27 Stedman Clinical Trials Tampa Florida United States 33613
    28 University of South Florida - Byrd Alzheimer's Institute Tampa Florida United States 33613
    29 iResearch Atlanta, LLC Decatur Georgia United States 30030
    30 Advocate Lutheran General Hospital Park Ridge Illinois United States 60068
    31 Southern Illinois School of Medicine Springfield Illinois United States 62702
    32 Indiana University Health - University Hospital Indianapolis Indiana United States 46202
    33 Cotton-O'Neil Clinical Research Center Topeka Kansas United States 66606
    34 KU Medical Center Wichita Clinical Trial Unit Wichita Kansas United States 67214
    35 University Of Kentucky Lexington Kentucky United States 40536
    36 Pennington Biomedical Research Center Baton Rouge Louisiana United States 70808
    37 Acadia Hospital Bangor Maine United States 04402
    38 Sheppard Pratt Health System Baltimore Maryland United States 21204
    39 Clinical Research Professionals Saint Louis Missouri United States 63141
    40 Princeton Medical Institute Princeton New Jersey United States 08540
    41 Advanced Memory Research Institute of NJ, PC - Internal Medicine Rahway New Jersey United States 07065
    42 Advanced Memory Research Institute Toms River New Jersey United States 08755
    43 Biobehavioral Health Toms River New Jersey United States 08755
    44 Neurology Specialists of Monmouth County West Long Branch New Jersey United States 07764
    45 Neurological Associates of Albany, PC Albany New York United States 12208
    46 Integrative Clinical Trials, LLC Brooklyn New York United States 11229
    47 SPRI Clinical Trials, LLC Brooklyn New York United States 11235
    48 Mid Hudson Medical Research New Windsor New York United States 12553
    49 New York University New York New York United States 10016
    50 Eastside Comprehensive Medical Center, LLC New York New York United States 10021
    51 Manhattan Behavioral Medicine New York New York United States 10022
    52 Upstate University Hospital (SUNY Health Science Center) Syracuse New York United States 13210
    53 Five Towns Neuroscience Research Woodmere New York United States 11598
    54 New Hope Clinical Research Charlotte North Carolina United States 28211
    55 Alzheimer Memory Center Charlotte North Carolina United States 28270
    56 Richard Weisler, MD, PA Raleigh North Carolina United States 27609
    57 Ohio Clinical Research Partners, LLC Canton Ohio United States 44718
    58 Valley Medical Research Centerville Ohio United States 45459
    59 Cleveland Clinic Main Campus Cleveland Ohio United States 44195
    60 IPS Research Company Oklahoma City Oklahoma United States 73103
    61 Lynn Health Science Institute Oklahoma City Oklahoma United States 73112
    62 Tulsa Clinical Research, LLC Tulsa Oklahoma United States 74104
    63 Lehigh Valley Health Network Allentown Pennsylvania United States 18103
    64 Northeastern Pennsylvania Memory and Alzheimers Center Plains Pennsylvania United States 18705
    65 Roper St. Francis Healthcare Charleston South Carolina United States 29401
    66 University of North Texas Health Science Center Fort Worth Texas United States 76107
    67 Shepherd Healthcare Lewisville Texas United States 75067
    68 Radiant Research, Inc. San Antonio Texas United States 78229
    69 Wasatch Clinical Research Salt Lake City Utah United States 84107
    70 Center for Alzheimer's Care, Imaging and Research Salt Lake City Utah United States 84108
    71 Independent Psychiatric Consultants, SC, dba Waukesha Wisconsin United States 53188

    Sponsors and Collaborators

    • Suven Life Sciences Limited

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Suven Life Sciences Limited
    ClinicalTrials.gov Identifier:
    NCT02580305
    Other Study ID Numbers:
    • CTP2S1502HT6
    First Posted:
    Oct 20, 2015
    Last Update Posted:
    Nov 23, 2020
    Last Verified:
    Nov 1, 2020
    Keywords provided by Suven Life Sciences Limited
    SUVN-502
    5-HT6
    Phase 2
    Cognition
    Donepezil
    Memantine
    Alzheimer's Disease
    Triple Combination
    Proof of Concept (POC)
    Additional relevant MeSH terms:
    Alzheimer Disease
    Memantine
    Donepezil
    1-((2-bromophenyl)sulfonyl)-5-methoxy-3-((4-methyl-1-piperazinyl)methyl)-1H-indole dimesylate monohydrate

    Study Results

    No Results Posted as of Nov 23, 2020