protocolSection identificationModule nctId: NCT06362707, orgStudyIdInfo id: 2023161001, briefTitle: Fasudil Trial for Treatment of Early Alzheimer's Disease (FEAD), acronym: FEAD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2026-10-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Helse Stavanger HF, class: OTHER_GOV, collaborators name: University of Exeter, descriptionModule briefSummary: 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., conditionsModule conditions: Cognitive Decline, Mild, conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Fasudil, interventions name: Placebo, outcomesModule primaryOutcomes measure: Cognition, primaryOutcomes measure: Brain metabolism, secondaryOutcomes measure: Plasma levels of ptau217, secondaryOutcomes measure: Plasma levels of nfl, secondaryOutcomes measure: Levels of cerebrospinal Aβ1-40 and Aβ1-42, secondaryOutcomes measure: Levels of cerebrospinal tau and p-tau, secondaryOutcomes measure: Blood pressure (Safety assessments), secondaryOutcomes measure: Pulse (Safety assessments), secondaryOutcomes measure: Urine testing (Safety assessments), secondaryOutcomes measure: Blood urea nitrogen (BUN) (Safety assessments), secondaryOutcomes measure: Potassium (Safety assessments), secondaryOutcomes measure: Sodium (Safety assessments), secondaryOutcomes measure: Calcium (Safety assessments), secondaryOutcomes measure: Glucose (Safety assessments), secondaryOutcomes measure: Hemoglobin (Safety assessments), secondaryOutcomes measure: Creatinine (Safety assessments), secondaryOutcomes measure: Total and direct bilirubin (Safety assessments), secondaryOutcomes measure: CRP (C-reactive protein) (Safety assessments), secondaryOutcomes measure: Aspartate aminotransferase (AST) (Safety assessments), secondaryOutcomes measure: Serum glutamic-oxaloacetic transaminase (SGOT) (Safety assessments), secondaryOutcomes measure: Alanine aminotransferase (ALT) (Safety assessments), secondaryOutcomes measure: Serum glutamic-pyruvic transaminase (SGPT) (Safety assessments), secondaryOutcomes measure: Alkaline phosphatase (Safety assessments), secondaryOutcomes measure: Electrocardiogram (ECG) (Safety assessments), secondaryOutcomes measure: Columbia Suicide Severity Rating Scale (C-SSRS) (Safety assessments), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False