OncoMatch/Clinical Trials/NCT06362707
Fasudil Trial for Treatment of Early Alzheimer's Disease (FEAD)
Is NCT06362707 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Fasudil for cognitive decline, mild.
Treatment: Fasudil — 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.
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage STAGE 3 MCI, STAGE 4 (MILD AD DEMENTIA) (FDA (2018))
Early AD, eg Stage 3 MCI or Stage 4 (mild AD dementia), as recently defined by the FDA (2018; Figure 2)
Performance status
CDR GLOBAL 0–1
A CDR Global rating of 0.5 or 1.0 (Morris 1993)
Lab requirements
Blood counts
WBC values ≥3.5 K/μl
Kidney function
No severe renal impairment (GFR ≥30). Serum creatinine or urea nitrogen values <3 times ULN at screening or baseline
Liver function
No moderate to severe hepatic impairment. Serum ALT or AST levels <3 times ULN at screening or baseline
Cardiac function
Clinically significant hypotension defined by blood pressure values <90/60 mmHg and associated with relevant clinical symptoms (e.g., tachycardia, dizziness, syncope); Corrected QT (QTc) interval <460 ms for males or <470 ms for females
Severe renal impairment (GFR <30) or serum creatinine or urea nitrogen values ≥3 times ULN at screening or baseline; Moderate to severe hepatic impairment. Serum ALT or AST levels ≥3 times ULN at screening or baseline; WBC values <3.5 K/μl; Clinically significant hypotension defined by blood pressure values <90/60 mmHg, regardless of the individual's sitting or standing position and associated with relevant clinical symptoms (e.g., tachycardia, dizziness, syncope); A Corrected QT (QTc) interval ≥ 460 milliseconds for males or ≥ 470 milliseconds for females will be considered abnormal during the ECG assessments
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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