Not recruiting

Study on Donanemab, Florbetapir, and Flortaucipir for Patients with Early Alzheimer's Disease

Fast replyInvestigationalNo placebo

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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 treatment for Alzheimer's Disease, a condition that affects memory and thinking skills. The treatment being tested is called Donanemab, which is an antibody designed to target a protein known as amyloid beta, believed to play a role in Alzheimer's. The study will also involve the use of two imaging agents, Florbetapir and Flortaucipir, which are solutions injected into the body to help visualize certain brain changes associated with Alzheimer's.

The purpose of this study is to assess how Donanemab affects the progression of early symptomatic Alzheimer's Disease compared to a placebo. Participants will receive either the treatment or a placebo through an infusion, which is a method of delivering medication directly into the bloodstream. The study will monitor participants over a period to observe any changes in their condition.

Throughout the study, participants will undergo various assessments, including brain scans using Florbetapir and Flortaucipir, to evaluate the treatment's impact on Alzheimer's Disease. These scans help researchers see how the disease progresses and how the treatment might alter this progression. The study aims to provide valuable insights into the safety and effectiveness of Donanemab in managing early Alzheimer's symptoms.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
The trial begins with an initial assessment to confirm eligibility. This includes a review of memory function changes over at least six months and a Mini-Mental State Examination (MMSE) score between 20 and 28.
A positron emission tomography (PET) scan using 18F flortaucipir and 18F florbetapir is conducted to meet specific criteria. A study partner must provide written consent to participate.
Step 2
Treatment phase
Participants receive donanemab or a placebo through an infusion. The solution is administered as an injection. The frequency and duration of administration are determined by the study protocol.
Step 3
Monitoring and evaluation
Regular monitoring is conducted to assess the safety and tolerability of the treatment. This includes tracking any side effects and overall health status.
The primary goal is to evaluate changes from baseline using the Integrated Alzheimer's Disease Rating Scale (iADRS).
Step 4
Completion and follow-up
Upon completion of the treatment phase, a final evaluation is conducted to assess the efficacy of donanemab compared to the placebo.
Participants may be asked to attend follow-up visits to monitor long-term effects and gather additional data.

Who can join the trial?

5 criteria

Participants must have a gradual and progressive change in memory function that has been noticed by themselves or someone close to them for at least 6 months.
Participants need to have a Mini-Mental State Examination (MMSE) score between 20 and 28. This is a test that helps measure memory and thinking abilities.
Participants must meet specific criteria on a brain scan called 18F flortaucipir PET scan, which is used to look at certain brain changes. This does not apply to a specific group focused on safety.
Participants must meet specific criteria on another brain scan called 18F florbetapir PET scan, which also looks at brain changes.
Participants need to have a study partner who agrees to join the study and provide written consent. This person will help provide information about the participant's condition.

Who cannot join the trial?

8 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.
Participants who are not in the early stages of Alzheimer's Disease are excluded. Early stages mean the initial phase when symptoms are just beginning to appear.
People who are not within the specified age range for the study cannot join. The age range is a specific group of ages that the study is focusing on.
Individuals who are not able to provide consent or understand the study requirements are excluded. Consent means agreeing to participate after understanding what the study involves.
Participants who have other medical conditions that might interfere with the study are not allowed. This means if you have another illness that could affect the study results, you cannot join.
People who are taking medications that could interfere with the study drug are excluded. This means if you are on certain medicines that might affect how the study drug works, you cannot participate.
Individuals who have participated in another clinical trial recently are not eligible. This is to ensure that previous study treatments do not affect the current study.
Pregnant or breastfeeding women cannot participate. This is to protect the health of the mother and baby.

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Verified sites

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

Verified
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk, Poland
Responsive
Diamond Clinic Sp. z o.o.
Cracow, Poland
Not recruiting
Responsive
Futuremeds Sp. z o.o.
Wroclaw, Poland

Trial locations

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Investigated drugs

Donanemab is a medication being studied for its potential to slow down the progression of early symptomatic Alzheimer's Disease. It is designed to target and remove certain proteins in the brain that are thought to contribute to the symptoms and progression of Alzheimer's Disease. The trial aims to evaluate the safety, tolerability, and effectiveness of this medication in patients who are in the early stages of the disease.

What is already known about the treatment

Donanemab – Donanemab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its potential use in treating early symptomatic Alzheimer's disease. The main therapeutic indication for donanemab is to slow the progression of Alzheimer's disease symptoms. At the molecular level, donanemab works by targeting and removing amyloid-beta plaques in the brain, which are believed to contribute to the cognitive decline seen in Alzheimer's patients. It is classified as a monoclonal antibody, a type of medication designed to specifically target and bind to certain proteins in the body.

Investigated diseases

Alzheimer Disease – Alzheimer's disease is a progressive neurological disorder that leads to the degeneration of brain cells, causing memory loss and cognitive decline. It typically begins with mild memory lapses and confusion, which gradually worsen over time. As the disease advances, individuals may experience difficulties with language, disorientation, mood swings, and behavioral changes. Eventually, it can impair the ability to carry out daily activities and recognize familiar people and places. The progression of symptoms varies among individuals, but it generally follows a slow and steady decline.