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Study on Fasudil Hydrochloride for Memory Loss Prevention in Early Alzheimer's Disease Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Fasudil Hydrochloride on individuals with Alzheimer's disease, specifically in its early stages. Alzheimer's disease is a condition that affects memory and other important mental functions. The trial will use Fasudil Hydrochloride, which is a type of medication known as a Rho-kinase (ROCK) inhibitor and is thought to have protective effects on the brain. Participants in the study will receive either Fasudil Hydrochloride or a placebo, which is a capsule that looks like the medication but does not contain the active substance.

The purpose of the study is to assess whether Fasudil Hydrochloride can help prevent memory loss in people with early Alzheimer's disease. The study will last for 12 months, during which participants will take the medication in capsule form by mouth. Throughout the study, participants will undergo various assessments to monitor their memory, attention, and overall brain function. These assessments will help researchers understand the potential benefits of Fasudil Hydrochloride in slowing down the progression of Alzheimer's disease.

Participants will also have regular check-ups to ensure their safety, including physical and neurological examinations, as well as tests like ECG (a test that checks the heart's electrical activity) and blood tests. The study will also look at changes in certain markers in the body that are related to Alzheimer's disease. By the end of the study, researchers hope to gather valuable information on the effectiveness and safety of Fasudil Hydrochloride for treating early Alzheimer's disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, language fluency, and medical history related to early Alzheimer's disease.
A reliable study partner is required to assist with evaluations and provide input on rating scales.
Step 2
Initial assessments
Initial assessments include a review of medical history, a physical and neurological examination, and baseline tests such as MRI scans and blood tests.
A pregnancy test is required for female participants of childbearing potential.
Step 3
Medication administration
Participants receive either Fasudil Hydrochloride or a placebo in capsule form.
The dosage is 40 mg taken three times daily (tds) for a duration of 12 months.
Step 4
Ongoing evaluations
Regular evaluations are conducted to monitor memory, attention, and executive function using the FLAME battery.
Safety data is collected through vital signs, weight checks, and laboratory tests.
Step 5
Final assessments
At the end of the 12-month period, final assessments are conducted to evaluate changes in memory and other cognitive functions.
Additional tests may include PET scans and assessments of daily living activities.

Who can join the trial?

9 criteria

The patient must have early **Alzheimer's disease**. This includes Stage 3 **Mild Cognitive Impairment (MCI)** or Stage 4, which is mild Alzheimer's dementia.
There must be a significant change in a validated Alzheimer's disease **biomarker**. Biomarkers are substances in the body that can indicate a disease. This can be determined by a special brain scan called an **amyloid PET scan**, or by testing certain proteins in the **cerebrospinal fluid (CSF)** or blood.
The patient should have a **Clinical Dementia Rating (CDR)** Global rating of 0.5 or 1.0. This is a scale used to measure the severity of dementia. Additionally, the patient must have had an **MRI scan** in the past two years that shows no results inconsistent with Alzheimer's disease.
The patient must be able to give **informed consent**, meaning they understand the study and agree to participate, as judged by an experienced doctor.
The patient needs to have a reliable study partner who has regular contact with them. This partner should be able to provide meaningful input into the study's assessments.
The patient must be at least 50 years old.
The patient must be fluent in Norwegian and show evidence of adequate intellectual functioning before the onset of Alzheimer's disease.
The patient must be capable of participating in all scheduled evaluations and completing all required tests.
Female patients must either be unable to have children or have a negative pregnancy test within 14 days before starting the study. They must also agree to use effective birth control during the study.

Who cannot join the trial?

5 criteria

Individuals who do not have a diagnosis of Alzheimer's disease cannot participate. Alzheimer's disease is a condition that affects memory and other mental functions.
People who are not in the early stages of Alzheimer's disease are excluded. Early stages mean the beginning phase of the disease.
Participants must be within a specific age range, typically adults and older adults. Those outside this age range cannot join.
Both males and females can participate, but anyone who does not identify as either may not be eligible.
Individuals considered part of a vulnerable population, such as those unable to give consent, are not included.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Akershus University Hospital
Verified
Lorenskog, Norway
Helse Fonna HF
Verified
Haugesund, Norway
Universitetssykehuset Nord-Norge HF
Responsive
Tromsø, Norway

Trial locations

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Investigated drugs

Fasudil is a medication being studied for its potential to help prevent memory loss in people with early Alzheimer's disease. It is being tested to see if it can slow down the progression of memory problems associated with this condition.

Fasudil Hydrochloride

What is already known about the treatment

Fasudil – Fasudil is administered orally in tablet form and is currently being studied in clinical trials for its potential use in treating early Alzheimer's disease. It is not yet widely recognized in medical literature as a standard treatment for this condition. The main therapeutic indication for Fasudil is to prevent memory loss associated with early Alzheimer's disease. At the molecular level, Fasudil works by inhibiting a specific enzyme called Rho-kinase, which is believed to play a role in the progression of Alzheimer's disease. It is classified pharmacologically as a Rho-kinase inhibitor.

Investigated diseases

Alzheimer's disease – Alzheimer's disease is a progressive neurological disorder that leads to memory loss and cognitive decline. It primarily affects older adults and is characterized by the gradual deterioration of brain cells. As the disease progresses, individuals may experience confusion, difficulty with language, and impaired reasoning. In the later stages, it can lead to significant memory loss and the inability to perform everyday tasks. The progression of Alzheimer's disease varies among individuals, but it typically worsens over time. The exact cause is not fully understood, but it involves a combination of genetic, environmental, and lifestyle factors.