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

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What is this study about?

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.

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.

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.

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).

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Diamond Clinic Sp. z o.o. Cracow Poland
Futuremeds Sp. z o.o. Wroclaw Poland
Galen Clinic Lublin Poland
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy Poznan Poland

Other Sites

Site Name City Country Status
Brain Research Center Amsterdam B.V. Amsterdam The Netherlands
Centrum Medyczne Neuromed Sp. z o.o. Bydgoszcz Poland
Brain Research Center Zwolle B.V. Zwolle The Netherlands
Centrum Medyczne Senior Sopot Poland
Euromedis Sp. z o.o. Szczecin Poland
Klimed MK Sp. z o.o. Bialystok Poland
A-Shine s.r.o. Plzen Czechia
Brain Research Center Den Bosch B.V. s-Hertogenbosch The Netherlands
Neuroprotect Sp. z o.o. Warsaw Poland
NZOZ Wrocławskie Centrum Alzheimerowskie Wroclaw Poland
Ccifmap Bqjco Kwfawgvhrsx Pnueapoc Siu z owpc Gdansk Poland
Oelzcao Bdskatee Nrvhxex Dwyfjubaftp Cazswi Olzwdkorgwv Iil Kpxcdkb Hjukcfj Kefhbawfi Ginqgrxuuajt Oeshlii Asduhrvtvtyrru Siu z oacm Scinawa Poland
Pfvwfamin Csaqrmy Popgmjlbqkwbwmu Bialystok Poland
Nozhsolaas Sac Zklexv St Siemianowice Slaskie Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
19.06.2020
Poland Poland
Not recruiting
19.06.2020
The Netherlands The Netherlands
Not recruiting
19.06.2020

Trial locations

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.

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.

Trial ID:
2023-507303-55-00
Protocol code:
I5T-MC-AACI
NCT ID:
NCT04437511
Trial Phase:
Therapeutic exploratory (Phase II)

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