NCT03625401

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

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Alzheimer Disease, Early Onset

Interventions

Type	Name	Description
DRUG	AD-35 60mg group	AD-35 60mg QD
DRUG	Placebo group	Placebo: 3 placebo of AD-35 30mg tablets

Timeline

• Start date: 2018-10-04
• Primary completion: 2020-12-01
• Completion: 2020-12-31
• First posted: 2018-08-10
• Last updated: 2020-03-25

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study