A Placebo-Controlled, Randomized Double-Blind Parallel Group 12-Month Trial of Fasudil for the Treatment of Early Alzheimer’s Disease
- Conditions
- Alzheimer's diseaseMedDRA version: 21.1Level: LLTClassification code: 10009846Term: Cognitive impairment Class: 10029205MedDRA version: 20.0Level: LLTClassification code: 10001896Term: Alzheimer's disease Class: 10029205Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2023-506514-44-00
- Lead Sponsor
- Helse Stavanger HF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
Early AD, eg Stage 3 MCI or Stage 4 (mild AD dementia), A significant change on a validated AD amyloid or tau biomarker (as determined either by visual reading of amyloid PET scans using any of the approved ligands, or CSF Aß 1-42 levels or blood p-tau 217 cut-offs as determined by the clinical research laboratory)., A CDR Global rating of 0.5 or 1.0 and have an MRI scan within the past two years that has no findings inconsistent with AD, Capacity to give informed consent based on the clinical judgement of an experienced clinician, The participant needs to have a reliable study partner with regular contact (a combination of face-to-face visits and telephone contact is acceptable) who has sufficient interaction with the participant to provide meaningful input into rating scales, Age from 50 years., Fluency in Norwegian and evidence of adequate premorbid intellectual functioning, Capable of participating in all scheduled evaluations and complete all required tests, Female participants must be of non-childbearing potential or have a negative serum pregnancy test within 14 days of baseline assessments and agree to the use of effective birth control throughout their participation in the study
Significant cerebrovascular disease, as indicated by clinical history, neurological examination, or on MRI (including cortical infarction or deep white matter or periventricular white matter hyperintensities with a Fazekas scale score of 3, Current clinically significant depression or other mental disorder likely to affect cognition or interfere with study participation, Recent (within 3 months) relevant medication changes. Participants must have been on stable anti-dementia (cholinesterase inhibitors or memantine) or anti-depressive medications for at least three months before the study, Participants using sedating drugs, if unavoidable, will be excluded from the study. However, short-acting sleep medications can be used if taken as recommended and if the participant has maintained stability on them for a minimum of 3 months prior to the start of the study, Participation in other drug trials, Currently ongoing life-threatening disease, such as metastatic cancer, advanced cardiovascular disease, advanced respiratory disease, terminal kidney disease, or advanced stages of infectious diseases, Any current or past neurological disease unrelated to Alzheimer's disease with cognitive sequelae, A QTc interval = 460 milliseconds for males or = 470 milliseconds for females will be considered abnormal during the ECG assessments, A history of cerebrovascular bleeding or severe bleeding of the digestive tract, lungs, nose or skin, 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 alanine transaminase (ALT) or aspartate transaminase levels =3 times ULN at screening or baseline, Currently poorly controlled diabetes as indicated by HbA1c values >9, White blood cell (WBC) values <3.5 K/µl, History of paralytic ileus or current severe chronic constipation, Known allergy to fasudil or established systemic inflammatory disease or autoimmune disease., 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of fasudil 40 mg tds in preventing memory loss in people with early AD.;Secondary Objective: Assess the impact of fasudil on various cognitive measures, brain metabolism using FDG-PET, and relevant clinical features and biofluid biomarkers, To evaluate the safety and tolerability of fasudil 40 mg tds administered for up to 12 months in people with early AD., To assess the efficacy of fasudil on brain pathology changes relevant to AD using validated fluid biomarkers, To evaluate additional exploratory clinical effects of fasudil 40 mg tds administered for up to 12 months in people with early AD.;Primary end point(s): The primary outcome will be the FLAME computer-based working memory composite, specifically the change over 12 months
- Secondary Outcome Measures
Name Time Method