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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02580305
Recruitment Status : Completed
First Posted : October 20, 2015
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Suven Life Sciences Limited

Tracking Information
First Submitted Date  ICMJE October 17, 2015
First Posted Date  ICMJE October 20, 2015
Last Update Posted Date November 18, 2019
Study Start Date  ICMJE September 2015
Actual Primary Completion Date November 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2015)
Change in cognition [ Time Frame: Screening, Baseline, Week 4, 13 and 26 ]
Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAScog -11) total score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2016)
  • Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) [ Time Frame: Baseline, Week 4, 13 and 26 ]
    Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
  • Change in functioning [ Time Frame: Baseline, Week 4, 13 and 26 ]
    Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) total score
  • Change in behavioural disturbance [ Time Frame: Baseline, Week 4, 13 and 26 ]
    Neuropsychiatric Inventory (NPI) 12 item
  • Depression and Dementia [ Time Frame: Screening, Baseline, Week 4, 13. 26 and 30 ]
    Cornell Scale for Depression and Dementia (C-SDD)
  • Risk of suicidality [ Time Frame: Screening, Baseline, Week 4, 13. 26 and 30 ]
    Columbia Suicide Severity Rating Scale (C-SSRS)
  • Change in cognitive aspects of mental function [ Time Frame: Screening, Baseline, Week 4, 13 and 26 ]
    Change in Mini Mental State Examination (MMSE)
  • Safety and tolerability [ Time Frame: Up to 26 weeks and a 4-week safety follow up ]
    Number of patients with adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2015)
  • Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) [ Time Frame: Baseline, Week 4, 13 and 26 ]
    Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
  • Change in functioning [ Time Frame: Baseline, Week 4, 13 and 26 ]
    Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) total score
  • Change in behavioural disturbance [ Time Frame: Baseline, Week 4, 13 and 26 ]
    Neuropsychiatric Inventory (NPI) 12 item
  • Depression and Dementia [ Time Frame: Screening, Baseline, Week 4, 13. 26 and 30 ]
    Cornell Scale for Depression and Dementia (C-SDD)
  • Risk of suicidality [ Time Frame: Screening, Baseline, Week 4, 13. 26 and 30 ]
    Columbia Suicide Severity Rating Scale (C-SSRS)
  • Change in cognitive aspects of mental function [ Time Frame: Screening, Baseline, Week 4, 13 and 26 ]
    Change in Mini Mental State Examination (MMSE)
  • Safety and tolearability [ Time Frame: Up to 26 weeks and a 4-week safety follow up ]
    Number of patients with adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study
Official Title  ICMJE 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
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.
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® (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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: SUVN-502
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Experimental: SUVN-502 Low dose
    SUVN-502 Low dose adjunct to base treatment with Donepezil and Memantine
    Intervention: Drug: SUVN-502
  • Active Comparator: Experimental: SUVN-502 High dose
    SUVN-502 High dose adjunct to base treatment with Donepezil and Memantine
    Intervention: Drug: SUVN-502
  • Placebo Comparator: Placebo
    Placebo adjunct to base treatment with Donepezil and Memantine
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2018)
563
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2015)
537
Actual Study Completion Date  ICMJE November 7, 2019
Actual Primary Completion Date November 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Has a diagnosis of probable Alzheimer's disease based on the 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02580305
Other Study ID Numbers  ICMJE CTP2S1502HT6
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Suven Life Sciences Limited
Study Sponsor  ICMJE Suven Life Sciences Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Suven Life Sciences Limited
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP