NCT03283059

Octohydroaminoacridine Succinate Tablet for Mild-to-Moderate Alzheimer's Disease

Phase III Trial of Octohydroaminoacridine Succinate Tablet for Mild-to-Moderate Alzheimer's Disease: a 26 Weeks, Randomized, Double-blind, Double-dummy, Placebo- and Positive- Parallel Controlled and Extended Single Arm to 54 Weeks Multicentre Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Inhibition of acetylcholinesterase has been a effective treatment for Alzheimer's disease. Octohydroaminoacridine, a new acetylcholinesterase inhibitor, is a potential treatment for Alzheimer's disease. The investigators conducted a 26 weeks, randomized, double-blind, double-dummy, placebo- and positive- parallel controlled and extended single arm to 54 weeks multicentre phase III clinical trial to investigate the effects of octohydroaminoacridine in patients with mild-to-moderate Alzheimer's disease. Patients were randomized to receive placebo thrice daily, or octohydroaminoacridine 4 mg/TID or ARICEPT 5mg/QD.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Octohydroaminoacridine Succinate	Octohydroaminoacridine Succinate Tablet:4mg P.O. tid
DRUG	Aricept	Aricept 5mg/day, P.O.
DRUG	Placebos	Placebo Tablet: P.O. tid

Timeline

• Start date: 2017-08-16
• Primary completion: 2020-09-16
• Completion: 2021-02-16
• First posted: 2017-09-14
• Last updated: 2019-10-22

Locations

1 site across 1 country: China