FASUDIL HYDROCHLORIDE for Alzheimer's disease

Inclusion criteria

• {"criterion_text":"- Early AD, eg Stage 3 MCI or Stage 4 (mild AD dementia)\n- 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 Aβ 1-42 levels or blood p-tau 217 cut-offs as determined by the clinical research laboratory).\n- 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\n- Capacity to give informed consent based on the clinical judgement of an experienced clinician\n- 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\n- Age from 50 years.\n- Fluency in Norwegian and evidence of adequate premorbid intellectual functioning\n- Capable of participating in all scheduled evaluations and complete all required tests\n- 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"}

Exclusion criteria

• {"criterion_text":"- 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\n- Current clinically significant depression or other mental disorder likely to affect cognition or interfere with study participation\n- Recent (within one months) relevant medication changes. Participants must have been on stable anti-dementia (cholinesterase inhibitors or memantine) or anti-depressive medications for at least one month before the study\n- 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\n- Participation in other drug trials\n- Currently ongoing life-threatening disease, such as metastatic cancer, advanced cardiovascular disease, advanced respiratory disease, terminal kidney disease, or advanced stages of infectious diseases\n- Any current or past neurological disease unrelated to Alzheimer's disease with cognitive sequelae\n- A QTc interval ≥ 460 milliseconds for males or ≥ 470 milliseconds for females will be considered abnormal during the ECG assessments\n- A history of cerebrovascular bleeding or severe bleeding of the digestive tract, lungs, nose or skin\n- Severe renal impairment (GFR <30) or serum creatinine or urea nitrogen values ≥3 times ULN at screening or baseline\n- Moderate to severe hepatic impairment. Serum alanine transaminase (ALT) or aspartate transaminase levels ≥3 times ULN at screening or baseline\n- Currently poorly controlled diabetes as indicated by HbA1c values >9\n- White blood cell (WBC) values <3.5 K/µl\n- History of paralytic ileus or current severe chronic constipation\n- Known allergy to fasudil or established systemic inflammatory disease or autoimmune disease.\n- 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)"}

Primary endpoints

• {"endpoint_text":"- The primary outcome will be the FLAME computer-based working memory composite, specifically the change over 12 months","definition_or_measurement_approach":"Change over 12 months measured using the FLAME computer-based working memory composite (computer-based cognitive testing; measured as change from baseline to 12 months)."}

Secondary endpoints

• {"endpoint_text":"- Using FLAME battery to assess speed of attention, accuracy of attention and executive function","definition_or_measurement_approach":"Assessed using components of the FLAME battery (speed and accuracy metrics and executive function measures)."}
• {"endpoint_text":"- Measure the extension and severity of the AD hypometabolic pattern at FDG-PET","definition_or_measurement_approach":"Measured by FDG-PET imaging to assess extent and severity of AD hypometabolic pattern."}
• {"endpoint_text":"- Safety data will be collected through measurements of vital signs, weight, physical and neurological examination, clinical safety laboratory tests, ECG, and suicidality","definition_or_measurement_approach":"Safety assessed via vital signs, weight, physical and neurological exams, clinical laboratory tests, ECG, and suicidality assessments as recorded per protocol."}
• {"endpoint_text":"- Changes in CSF Aβ1-40, Aβ1-42, tau and p-tau and blood plasma ptau217, Nfl and other relevant markers of neurodegeneration will be assessed over 12 months.","definition_or_measurement_approach":"CSF and blood biomarkers (Aβ1-40, Aβ1-42, tau, p-tau, plasma ptau217, NfL and other markers) measured and compared over a 12-month period."}
• {"endpoint_text":"- Ability to perform everyday activities, and changes in functionality: Activities of daily living assessments using the Amsterdam ADL scale","definition_or_measurement_approach":"Functionality assessed using the Amsterdam Activities of Daily Living (ADL) scale; change from baseline over study period."}
• {"endpoint_text":"- Overall clinical condition: Clinical Global Impression of Change","definition_or_measurement_approach":"Assessed using the Clinical Global Impression of Change (CGI-C) scale."}
• {"endpoint_text":"- Severity of dementia symptoms: Clinical Dementia Rating (CDR)-sum of boxes","definition_or_measurement_approach":"Measured using the Clinical Dementia Rating (CDR) sum-of-boxes score; change from baseline."}
• {"endpoint_text":"- Neuropsychiatric symptoms and behaviors Neuropsychiatric Inventory (NPI-Q)","definition_or_measurement_approach":"Assessed using the NPI-Q to evaluate neuropsychiatric symptoms."}
• {"endpoint_text":"- Quality of life assessments using the DEMQOL and a short assessment of health-related costs using the EQ-5D questionnaire","definition_or_measurement_approach":"Quality of life measured using DEMQOL and health-related quality/costs measured by EQ-5D questionnaires."}

Methods

• Email to PROTECT participants (document: K2_Recruitment material_email PROTECT participant) — targeted outreach to existing PROTECT study participants in Norway
• Public websites (document: K2_Recruitment material_public websites) — general public information in Norway
• General practitioner outreach (document: K2_Recruitment material_general practitioner) — engagement via primary care clinicians in Norway
• Social media (document: K2_Recruitment material_social media) — online recruitment targeting the public in Norway
• Information sheet (document: K2_Recruitment material_information sheet) — participant-facing printed/digital information in Norwegian
• Flyer (document: K2_Recruitment material_flyer) — printed recruitment materials for distribution in Norway
• Patient card / Other subject information material (document: L2_Other subject information material_patient card_NO) — study identification and contact information for participants

Norway

Latest Decision Or Authorization Date

23-10-2025

Number Of Sites

6

Number Of Participants

200

Primary sponsor

Full Name

Helse Stavanger HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway