RecruitingPhase 2NCT06362707

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

A Placebo Controlled Randomized Double-blind Parallel Group 12-month Trial of Fasudil for the Treatment of Early Alzheimer's Disease (FEAD)

Sponsor

Helse Stavanger HF

Enrollment

200 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease Cognitive Decline, Mild

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.

Eligibility

Min Age: 50 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether fasudil, a drug that improves blood flow to the brain, can slow the progression of early-stage Alzheimer's disease in people who have mild memory problems or early dementia. **You may be eligible if...** - You have early Alzheimer's disease — either mild cognitive impairment (early memory concerns) or mild dementia - Your brain scans or lab tests show the protein buildup (amyloid or tau) associated with Alzheimer's - Your clinical assessment score (CDR) is 0.5 or 1.0 - You have had a brain MRI within the last two years - You have a reliable family member or caregiver who can participate in the study with you - You are able to give informed consent **You may NOT be eligible if...** - You do not have confirmed Alzheimer's-related biomarker changes - You have significant other neurological conditions - Your caregiver is unable to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFasudil

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.

DRUGPlacebo

Placebo tablets that look identical to the fasudil tablets and will follow the same dosing schedule as participants receiving fasudil.