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

NCT03283059 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2019-10-22

No results posted yet for this study

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

DRUG

Octohydroaminoacridine Succinate

Octohydroaminoacridine Succinate Tablet:4mg P.O. tid

DRUG

Aricept

Aricept 5mg/day, P.O.

DRUG

Placebos

Placebo Tablet: P.O. tid

Sponsors & Collaborators

  • Changchun Huayang High-tech Co., Ltd

    collaborator INDUSTRY

  • Jiangsu Sheneryang High-tech Co., Ltd

    collaborator UNKNOWN

  • Shanghai Mental Health Center

    lead OTHER

Principal Investigators

  • Shifu Xiao, M.D., Ph.D. · Shanghai Mental Health Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-08-16
Primary Completion
2020-09-16
Completion
2021-02-16

Countries

  • China

Study Locations

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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 NCT03283059 on ClinicalTrials.gov