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TRAILBLAZER-ALZ 2

Phase II trials

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Study Information

Name of the study

A Study of Donanemab (LY3002813) in participants with early Alzheimer's disease

Study sponsor

Eli Lilly and Company

Disease

Early Alzheimer's disease

Phase

Phase II

Information about the drug that will be tested in the studies

Name of the drug

Donanemab

Administration

The drug will be administered via an intravenous infusion (an injection into the vein).

Is the drug already on the market for another medical condition?

No

Will all participants receive the same drug?

Participants will be selected by chance to receive one of the following options:

  • An intravenous infusion of Donanemab
  • An intravenous infusion of placebo (inactive substance identical in appearance to the drug being tested).

Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the safety, tolerability and efficacy of Donanemab in people with early symptomatic Alzheimer's disease.

How long will the treatment last? 

Around 1.5 year.

What will your involvement entail?

  • During the study, participants will have to undergo brain scan (MRI, PET) to see if they have amyloid pathology in their brain
  • Complete a memory test (MMSE) to assess cognitive function
  • Complete a test that will assess memory, orientation, judgment and problem solving, personal care and community affairs (this is a test called CDR)
  • Participants will also need to complete some other tests to evaluate their cognition, behaviour, function and quality of life, activities of daily living (e.g. ADAS-Cog, ADCS-iADL).

Further information on the procedures can be obtained from the study team. 

Who can participate in the study?

To take part in the study, participants must:

  • Be 60 to 85 years old
  • Have a gradual and progressive change in memory function for the past 6 months
  • Have a score between 20 and 28 points in the MMSE test (a test about your memory). This would suggest that the person has an impairment in their memory that is at a very mild stage
  • Have a study partner who has a sufficient contact with the participant, is willing to participate in study procedures throughout the study duration.

Who cannot participate in the study?

Exclusion criteria include:

  • Contraindication to PET imaging and MRI procedures
  • A current treatment with immunoglobulin G (IgG) therapy (people with immunodeficiency diseases involving poor IgG antibody (found in blood plasma) often benefit from a medical treatment called immunoglobulin G therapy.

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study. 

Where and when will the study be conducted?

European countries involved in the trial

  • Netherlands
  • Poland

Information for your doctor

EudraCT Number

2020-000077-25

Clinicaltrials.gov identifier

NCT04437511

Study contact information

Clinicaltrials.gov@lilly.com

Link to full text

https://clinicaltrials.gov/ct2/show/NCT04437511

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on February 2021.

The pharmaceutical company running this trial has reviewed this document.

This document has been reviewed by a member of the European Working Group of People with Dementia.

 

 
 

Last Updated: Friday 12 February 2021

 

 
 

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