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A Placebo-Controlled, Randomized Double-Blind Parallel Group 12-Month Trial of Fasudil for the Treatment of Early Alzheimer’s Disease
EU CTIS ID: 2023-506514-44-00
What this study is testing
To assess the efficacy of fasudil 40 mg tds in preventing memory loss in people with early AD.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 Aβ 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.
You likely can't join if
- 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 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
- 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
See the full eligibility criteria
Who can join
- 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 Aβ 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
What rules you out
- 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 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
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.