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New treatment option for Cognitive Decline, Mild
Official title Fasudil Trial for Treatment of Early Alzheimer's Disease (FEAD)
ClinicalTrials.gov ID: NCT06362707
What this study is testing
What is Fasudil?
Fasudil is an investigational medicine, given as an once-daily, being studied as a potential treatment for cognitive decline, mild.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- Time commitment: about 50 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 100
You may be able to join if
- Early AD, eg Stage 3 MCI or Stage 4 (mild AD dementia), as recently defined by the FDA (2018; Figure 2)
- 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...
- A CDR Global rating of 0.5 or 1.0 (Morris 1993) 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...
You likely can't join if
- Significant cerebrovascular disease, as indicated by clinical history, neurological examination, or on MRI (including cortical infarction or deep...
- 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 Upper normal limit (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
See the full eligibility criteria
- Early AD, eg Stage 3 MCI or Stage 4 (mild AD dementia), as recently defined by the FDA (2018; Figure 2)
- 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...
- A CDR Global rating of 0.5 or 1.0 (Morris 1993) 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...
- 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...
- 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...
- 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 Upper normal limit (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...
- 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...
- 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 Corrected QT (QTc) interval ≥ 460 milliseconds for males or ≥ 470 milliseconds for females will be considered abnormal during the ECG assessments
The study team makes the final eligibility decision.
Where it's taking place
- Tromsø, Nordland, Norway
- Oslo, Oslo, Norway
- Haugesund, Rogaland, Norway
- Stavanger, Rogaland, Norway
- Trondheim, Trøndelag, Norway
- Bergen, Vestland, Norway
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 study runs about 50 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tromsø, Nordland, Norway; Oslo, Oslo, Norway; Haugesund, Rogaland, Norway; Stavanger, Rogaland, Norway; Trondheim, Trøndelag, Norway; Bergen, Vestland, Norway. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.