Study on the Effects of Phenserine and Donepezil in Patients with Early or Mild Alzheimer’s Disease

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What is this study about?

This clinical trial is focused on studying the effects of two medications, Phenserine and Donepezil, in people with early or mild Alzheimer’s disease. Alzheimer’s disease is a condition that affects memory and thinking skills. The study aims to compare how these medications affect certain biological markers related to cell health in the brain.

Participants in the study will receive either Phenserine or Donepezil over a period of several weeks. Phenserine is taken in capsule form, while Donepezil is available as film-coated tablets. The study will monitor changes in specific markers in the body that are linked to Alzheimer’s disease, as well as the safety and tolerability of the medications. Participants will be observed for any side effects and changes in their health during the study.

The study will also assess how well participants adhere to the treatment schedule and any changes in their cognitive abilities, such as memory and attention, using various tests. The goal is to better understand the potential benefits and risks of these medications in treating early or mild Alzheimer’s disease.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a diagnosis of Alzheimer’s disease based on specific criteria.

An MRI scan from the past two years is reviewed to ensure there are no findings inconsistent with Alzheimer’s disease.

2 medication washout period

Participants who have recently been treated with certain medications, such as memantine or acetylcholinesterase inhibitors, must undergo a washout period of at least 4 weeks before starting the study.

3 baseline evaluations

Baseline evaluations are conducted, including cognitive assessments and biomarker analysis from cerebrospinal fluid and blood samples.

The Montreal Cognitive Assessment (MoCA) is administered to evaluate cognitive function.

4 medication administration

Participants are randomly assigned to receive either donepezil or phenserine.

Donepezil is administered orally in the form of film-coated tablets, available in 5 mg or 10 mg doses.

Phenserine is administered orally in the form of capsules. The specific dosage and frequency are determined based on the study protocol.

5 treatment period

The treatment period lasts for 8 weeks. During this time, participants continue to take their assigned medication as directed.

Regular assessments are conducted to monitor safety, tolerability, and changes in cognitive function and biomarkers.

6 follow-up evaluations

At the end of the treatment period, follow-up evaluations are conducted. These include cognitive assessments and biomarker analysis to assess the effects of the medication.

The Montreal Cognitive Assessment (MoCA) is administered again to evaluate any changes in cognitive function.

7 study completion

Upon completion of the study, participants are provided with information about their participation and any relevant findings related to their health.

Who Can Join the Study?

Have a diagnosis of Alzheimer’s Disease (AD) based on the most recent guidelines.
Be able to participate in all scheduled evaluations and complete all required tests.
Females who can have children and males must agree to use highly effective birth control methods from the time they sign the consent form until at least 30 days after the last dose of the study medication.
Show a significant change in a validated AD amyloid or tau biomarker. This can be determined by a special brain scan called an amyloid PET scan or by specific tests on spinal fluid or blood.
Have Mild Cognitive Impairment (MCI) or mild dementia, as determined by a specific rating scale.
Have had an MRI scan in the past two years that shows no findings inconsistent with AD.
If recently participated in other clinical trials or treated with certain medications like memantine or acetylcholinesterase inhibitors (e.g., Donepezil, Rivastigmine, Galantamine), must have a break of at least 4 weeks before starting the study.
Be able to give informed consent, as judged by an experienced clinician.
Have someone who is in regular contact, either by phone or in person, who can act as a reliable study partner and provide meaningful input into rating scales.
Be at least 50 years old.
Be fluent in Norwegian and have evidence of adequate intellectual functioning before the onset of symptoms.

Who Cannot Join the Study?

Individuals with any condition other than Mild Cognitive Impairment or Alzheimer’s disease.
Individuals who are not within the specified age range for the study.
Individuals who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Universitetssykehuset Nord-Norge HF	Tromsø	Norway
St. Olavs Hospital HF	Trondheim	Norway
Helse Stavanger HF	Stavanger	Norway
Hihsq Frbbr Hq	Haugesund	Norway
Ajajtehr Uiwiclrulz Hyelapul	Lorenskog	Norway

Trial status

Country	Status	Recruitment Start
Norway	Not recruiting	01.01.2025

Trial locations

Investigated drugs:

Phenserine is a medication being studied for its potential effects on Alzheimer’s disease. It is being tested to see how it impacts certain biomarkers related to cell death in the brain. This could help in understanding how the disease progresses and whether phenserine can slow down or alter this process.

Donepezil is a medication commonly used to treat symptoms of Alzheimer’s disease. It works by increasing the levels of a certain natural substance in the brain, which may help improve memory, awareness, and the ability to function. In this study, donepezil is being used as a comparison to see how phenserine performs against a well-known treatment.

Mild Cognitive Impairment – This condition involves noticeable problems with memory, language, thinking, or judgment that are greater than typical age-related changes but not severe enough to interfere significantly with daily life. Individuals with mild cognitive impairment may experience forgetfulness, difficulty in finding words, or trouble with complex tasks. The condition can remain stable for years, but in some cases, it may progress to more severe cognitive disorders. It is often considered an intermediate stage between normal cognitive aging and more serious conditions like dementia.

Alzheimer’s Disease – Alzheimer’s disease is a progressive neurological disorder that leads to memory loss and cognitive decline. It typically starts with mild memory problems and confusion, gradually worsening over time. As the disease advances, individuals may experience significant memory loss, disorientation, and difficulty with language and reasoning. The progression of Alzheimer’s disease can vary, but it generally leads to a decline in the ability to perform everyday activities.

Trial ID:

2023-510282-10-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Effects of Phenserine and Donepezil in Patients with Early or Mild Alzheimer’s Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?