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Fasudil Trial for Treatment of Early Alzheimer's Disease (FEAD)
Sponsor: Helse Stavanger HF
Summary
The goal of this placebo-controlled double-blind Phase 2 clinical trial is to test in people with early Alzheimer's Disease. The main questions it aims to answer are: * Does treatment with fasudil, a ROCK-inhibitor, lead to significant improvement in working memory (based on computer-based working memory composite scores) compared to placebo in individuals with early Alzheimer's disease (AD) over 12 months? * What is the effect of fasudil treatment for 12 months on other cognitive functions, brain metabolism measured by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET), and other relevant clinical functions and biomarkers in individuals with early Alzheimer's disease (AD)? * Treatment will be escalated to a maintenance dose of 120 mg total daily dose for up to 50 weeks, with regular clinic visits for efficacy and safety evaluations. * Assessments will include cognitive tests, FDG-PET scans, and biomarker analyses, with follow-up by the Data and Safety Monitoring Board for ongoing safety review. The study will compare participants receiving fasudil with those receiving placebo to see if fasudil treatment leads to improvements in cognitive functions, brain metabolism measured by FDG-PET.
Official title: A Placebo Controlled Randomized Double-blind Parallel Group 12-month Trial of Fasudil for the Treatment of Early Alzheimer's Disease (FEAD)
Key Details
Gender
All
Age Range
50 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-08-01
Completion Date
2026-10-01
Last Updated
2024-10-22
Healthy Volunteers
No
Conditions
Interventions
Fasudil
A ROCK inhibitor approved for treating vasospasms following subarachnoidal bleeding in Japan and China. Dosage: Participants will undergo a 2-week titration period at 60 mg daily before escalating to a maintenance dose of 120 mg daily.
Placebo
Placebo tablets that look identical to the fasudil tablets and will follow the same dosing schedule as participants receiving fasudil.
Locations (6)
University Hospital of North Norway
Tromsø, Nordland, Norway
Akershus Hospital:
Oslo, Oslo County, Norway
Haugesund Hospital
Haugesund, Rogaland, Norway
Stavanger University Hospital
Stavanger, Rogaland, Norway
St. Olavs Hospital:
Trondheim, Trøndelag, Norway
Haraldsplass Deaconess Hospital
Bergen, Vestland, Norway