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

NCT02580305 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 564

Last updated 2023-06-09

Study results available
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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.

Conditions

Interventions

DRUG

SUVN-502

Once-daily, tablets, orally

DRUG

Placebo

Once-daily, tablets, orally

DRUG

Donepezil

Donepezil HCl (10 mg, once a day)

DRUG

Memantine

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

Sponsors & Collaborators

  • Suven Life Sciences Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-11-05
Completion
2019-11-07

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02580305 on ClinicalTrials.gov