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RECRUITING
NCT06362707
PHASE2

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

Sponsor: Helse Stavanger HF

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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