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

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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 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.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

11 criteria

  • 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 trial?

3 criteria

  • 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.
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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.

What is already known about the treatment

  • Phenserine

    This medication is administered orally and is currently being studied in clinical trials for its potential use in treating early or mild Alzheimer's disease. It is not yet widely recognized in medical literature as a standard treatment. The main therapeutic indication for phenserine is to address cognitive impairment associated with Alzheimer's disease. At the molecular level, phenserine works by inhibiting the enzyme acetylcholinesterase, which increases the levels of acetylcholine in the brain, potentially improving cognitive function. It is classified pharmacologically as an acetylcholinesterase inhibitor.

  • Donepezil

    This medication is also administered orally and is an established treatment for Alzheimer's disease, widely recognized in medical literature. It is primarily used to treat symptoms of mild to moderate Alzheimer's disease. Donepezil works by inhibiting the enzyme acetylcholinesterase, which leads to increased levels of acetylcholine in the brain, helping to improve or maintain cognitive function. It belongs to the pharmacological class of acetylcholinesterase inhibitors.

Investigated diseases

  • 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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-510282-10-00Estimated enrolment16 patientsSponsorHelse Stavanger HF

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