Efficacy and Safety of AD-35 in Treatment of Subjects With Mild to Moderate Alzheimer's Disease — ROAD  

Alzheimer Disease, Early Onset Clinical Trial

Official title: A Pilot, Phase 2a, Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Safety and Tolerability, Efficacy, and Pharmacokinetics of AD-35 in Subjects With Mild to Moderate Alzheimer's Disease

Status Active, not recruiting

Clinical Trial Summary

multi-center, randomized, double-blind, parallel-group,placebo-controlled study to evaluate the safety and tolerability, efficacy, and PK of 60 mg AD-35 administered QD during 6 months of double-blind treatment followed by a second 6 months of open-label treatment to subjects with mild to moderate AD.

Clinical Trial Description

Approximately 55 subjects are planned to be enrolled for the entire study. Subjects will be randomized on Day 1 via a centralized interactive response technology (IRT) in a 1:2 ratio to receive placebo or 60 mg AD-35. The Data Safety Monitoring Board (DSMB) will review safety information after the first 30 subjects have completed the Day 30 Visit and make any necessary recommendations regarding changes to the conduct of the study.

After the first 6 months of double-blind treatment, subjects initially on placebo will transition to active study drug, and all subjects will receive 60 mg AD-35 for an additional 6 months of open-label treatment. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease, Early Onset

• NCT number: NCT03625401
• Study type: Interventional
• Source: Zhejiang Hisun Pharmaceutical Co. Ltd.
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 4, 2018
• Completion date: December 31, 2020