NCT02580305

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 564 (actual)
• Sponsor: Suven Life Sciences Limited · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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® (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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-11-05
• Completion: 2019-11-07
• First posted: 2015-10-20
• Last updated: 2023-06-09
• Results posted: 2023-06-09

Locations

71 sites across 1 country: United States