Phase 2 Double-Blind 12-Month Study of Fasudil Compared to Placebo for Early Alzheimers Disease Treatment

What this Trial Is About

Researchers are evaluating fasudil, a ROCK-inhibitor, in people with early Alzheimers disease AD to see if it improves working memory compared to placebo over 12 months. This Phase 2, placebo-controlled, double-blind trial aims to assess the effects of fasudil on cognitive functions, brain metabolism using FDG-PET scans, and other clinical functions and biomarkers in individuals with early AD. Fasudil has shown neuroprotective effects in animal models and is approved in some countries for other uses. The study involves two groups one receiving fasudil and the other receiving a matching placebo. Participants start with a 2-week titration period at 60 mg daily, then increase to a maintenance dose of 120 mg daily for up to 50 weeks. Visits for safety and efficacy evaluations occur every two weeks for the first month and monthly thereafter. The trial enrolls up to 200 people in three cohorts of increasing size, with random assignment to fasudil or placebo. Participants attend regular clinic visits for cognitive testing, FDG-PET scans, and biomarker collection including blood and cerebrospinal fluid samples. Safety is monitored through monthly assessments of vital signs, lab tests, ECGs, and suicide risk scales. The main outcomes include changes in working memory scores and brain metabolism after 12 months. The trial includes ongoing safety review by a Data and Safety Monitoring Board and lasts about one year per participant.

Fasudil Trial for Treatment of Early Alzheimer's Disease (FEAD)