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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Suven Life Sciences Limited
Sponsor:
Information provided by (Responsible Party):
Suven Life Sciences Limited
ClinicalTrials.gov Identifier:
NCT02580305
First received: October 17, 2015
Last updated: September 5, 2017
Last verified: September 2017
  Purpose
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 Intervention Phase
Alzheimer's Disease Drug: SUVN-502 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Suven Life Sciences Limited:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 537
Study Start Date: September 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Experimental: SUVN-502 Low dose
SUVN-502 Low dose adjunct to base treatment with Donepezil and Memantine
Drug: SUVN-502
Active Comparator: Experimental: SUVN-502 High dose
SUVN-502 High dose adjunct to base treatment with Donepezil and Memantine
Drug: SUVN-502
Placebo Comparator: Placebo
Placebo adjunct to base treatment with Donepezil and Memantine
Drug: Placebo

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02580305

Contacts
Contact: Ramakrishna Nirogi suvn502study@suven.com

  Show 63 Study Locations
Sponsors and Collaborators
Suven Life Sciences Limited
  More Information

Responsible Party: Suven Life Sciences Limited
ClinicalTrials.gov Identifier: NCT02580305     History of Changes
Other Study ID Numbers: CTP2S1502HT6
Study First Received: October 17, 2015
Last Updated: September 5, 2017

Keywords provided by Suven Life Sciences Limited:
SUVN-502
5-HT6
Phase 2
Cognition
Donepezil
Memantine
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Donepezil
Memantine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents

ClinicalTrials.gov processed this record on September 19, 2017