Actively Recruiting
Fasudil Trial for Treatment of Early Alzheimer's Disease (FEAD)
Led by Helse Stavanger HF · Updated on 2026-05-04
200
Participants Needed
6
Research Sites
178 weeks
Total Duration
On this page
Sponsors
H
Helse Stavanger HF
Lead Sponsor
U
University of Exeter
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fasudil Trial for Treatment of Early Alzheimer's Disease (FEAD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with early Alzheimer's disease, such as Stage 3 mild cognitive impairment or Stage 4 mild dementia, as defined by FDA guidance
- Significant change on a validated Alzheimer's biomarker, such as amyloid PET scan or CSF/blood markers
- Clinical Dementia Rating (CDR) Global score of 0.5 or 1.0
- MRI scan within the past two years with no findings inconsistent with Alzheimer's disease
- Ability to give informed consent as determined by an experienced clinician
- Having a reliable study partner with regular contact who can provide meaningful input
- Age between 50 and 100 years
- Fluency in Norwegian with adequate premorbid intellectual functioning
- Capable of completing all scheduled evaluations and tests
- Female participants must be of non-childbearing potential or have a negative pregnancy test within 14 days before baseline and agree to use effective birth control during the study
You will not qualify if you...
- Significant cerebrovascular disease indicated by clinical history, neurological exam, or MRI
- History of cerebrovascular bleeding or severe bleeding in digestive tract, lungs, nose, or skin
- Severe kidney impairment or abnormal kidney-related lab values
- Moderate to severe liver impairment or elevated liver enzyme levels
- Poorly controlled diabetes with HbA1c over 9
- Low white blood cell count below 3.5 K/µl
- History of paralytic ileus or severe chronic constipation
- Known allergy to fasudil or systemic inflammatory/autoimmune diseases
- Clinically significant low blood pressure with symptoms
- Current significant depression or mental disorder affecting cognition or participation
- Recent medication changes within 3 months; must be stable on dementia or antidepressant meds
- Use of sedating drugs unless stable short-acting sleep medications used appropriately
- Participation in other drug trials
- Ongoing life-threatening diseases such as metastatic cancer, advanced cardiovascular, respiratory, or kidney disease, or advanced infections
- Other neurological diseases unrelated to Alzheimer's with cognitive effects
- Abnormal ECG with corrected QT interval ≥460 ms for males or ≥470 ms for females
AI-Screening
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Trial Site Locations
Total: 6 locations
1
University Hospital of North Norway
Tromsø, Nordland, Norway
Not Yet Recruiting
2
Akershus Hospital:
Oslo, Oslo, Norway
Not Yet Recruiting
3
Haugesund Hospital
Haugesund, Rogaland, Norway
Not Yet Recruiting
4
Stavanger University Hospital
Stavanger, Rogaland, Norway
Actively Recruiting
5
St. Olavs Hospital:
Trondheim, Trøndelag, Norway
Not Yet Recruiting
6
Haraldsplass Deaconess Hospital
Bergen, Vestland, Norway
Enrolling by Invitation
Research Team
D
Dag Aarsland, PhD
CONTACT
N
Nicolas Castellanos Perilla, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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