Recruiting

A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

I5T-MC-AACH - ClinicalTrials.gov - NCT04640077

The main goals of this study are to further determine whether the study drug donanemab is safe and effective in participants with Alzheimer’s disease and to validate video scale assessments.
How long will I be in the trial?
The study will last about 124 weeks and may include up to 20 visits.
Email
Recruiting

A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

I5T-MC-AACH - ClinicalTrials.gov - NCT04640077

The main goals of this study are to further determine whether the study drug donanemab is safe and effective in participants with Alzheimer’s disease and to validate video scale assessments.
How long will I be in the trial?
The study will last about 124 weeks and may include up to 20 visits.
Email

Key Requirements

Age :

60-90

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

60-90

Sex

All

Participants must

Participants must have gradual and progressive change in memory function reported by participants or informants for ≥ 6 months

Participants must have have MMSE score of 20 to 28 (inclusive) at baseline

Participants must have 18F flortaucipir PET scan (central read) criteria

Participants must have met 18F florbetapir PET scan (central read) criteria

Participants must have a study partner who will provide written informed consent to participate

Participants must NOT

Participants must not have contraindication to MRI or PET scans

Participants must not receive current treatment with immunoglobin G (IgG) therapy

Trial Summary

Conditions the trial is for

Early Symptoms of Alzheimer's Disease

What the trial is testing?

Donanemab

Could I receive a Placebo?

no

Enrollment Goal

100

Trial Dates

November 2020 - March 2023

Trial Phase

2

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

60-90

Sex

All

Participants must

Participants must have gradual and progressive change in memory function reported by participants or informants for ≥ 6 months

Participants must have have MMSE score of 20 to 28 (inclusive) at baseline

Participants must have 18F flortaucipir PET scan (central read) criteria

Participants must have met 18F florbetapir PET scan (central read) criteria

Participants must have a study partner who will provide written informed consent to participate

Participants must NOT

Participants must not have contraindication to MRI or PET scans

Participants must not receive current treatment with immunoglobin G (IgG) therapy

Trial Summary

Conditions the trial is for

Early Symptoms of Alzheimer's Disease

What the trial is testing?

Donanemab

Could I receive a Placebo?

no

Enrollment Goal

100

Trial Dates

November 2020 - March 2023

Trial Phase

2

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Trial Locations

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Early Symptoms of Alzheimer's Disease Resources

Memory, Alzheimer’s Disease, and Research Studies

Memory, Alzheimer’s Disease, and Research Studies

With the help of research study participants, we are learning about aging, memory, and potential new approaches to fighting Alzheimer’s disease.
Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?