FEAD

Information about the drug that will be tested in the study

Administration

Oral tablet 3-times daily

Is the drug already on the market for another medical condition?

Fasudil is approved in Japan and China for the treatment of cerebral vasospasm, often following a bleed on the brain.

Will all participants receive the same drug?

Participants will be selected by chance to receive one of the following options:

• Oral tablet of Fasudil
• Oral tablet of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).

Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the efficacy and safety of Fasudil for the treatment of early Alzheimer's disease..

How long will the treatment last?

• 12 months

What your involvement will entail?

• During the study, participants will be asked to complete some tests that will assess cognition, memory, attention, executive functions and daily living activities
• To undergo brain scans (e.g. MRI, PET) and lumbar puncture (CSF)
• To provide blood and urine samples for laboratory analysis. Safety laboratory tests, will be performed to assess various health parameters.

Further information on the procedures, tests and number of visits can be obtained from the study team.

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

• Be between 50 and 100 years old
• Have a diagnosis of early Alzheimer’s disease (mild cognitive impairment of mild Alzheimer’s disease dementia)
• Have evidence of abnormal accumulation of amyloid or tau in the brain (determined either through CSF examination (lumbar puncture) or with the use of an amyloid PET scan)
• Have a score of 0.5 or 1 in the Clinical Dementia Rating Global Score (CDR)
• Have results of an MRI scan within the past two years that has no findings inconsistent with Alzheimer’s disease
• Have a study partner who has a sufficient contact with the participant, is willing to participate in study procedures throughout the study duration
• Fluent in Norwegian.

Who cannot participate in the study?

People cannot take part in the study if they have or have experienced:

• A disease or condition that may interfere with the safety, tolerability and/or study assessments (e.g., depression, mental disorder)
• Significant brain injuries or disease such as stroke, cortical infarction, etc..
• A history of severe bleeding of the digestive tract, lungs, nose or skin
• Severe kidney impairment or moderate to severe liver impairment
• Currently poorly controlled diabetes
• Clinically significant hypotension
• If the person is taking approved symptomatic medication for dementia (i.e. cholinesterase inhibitors or memantine) or anti-depressive drugs, the dosing regimen must have been stable for at least three months prior before 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.

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.

Information for your doctor

EudraCT Number

2023-506514-44-00

Clinicaltrials.gov identifier

NCT06362707

Study contact information

Dag Aarsland, +4797575804    daarsland@gmail.com

Nicolas Castellanos Perilla, +4741279857     mailto:nicolascastellanos1107@gmail.com

Link to full text

https://clinicaltrials.gov/study/NCT06362707 

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on July 2024.

This document has been reviewed by the pharmaceutical company running this trial.

This document has been reviewed by a member of the European Dementia Carers Working Group.