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

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
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.
Epistemonikos ID: db330aed3aecb782fb047c9f7187573e81526c00
First added on: May 21, 2024