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.
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.
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 - October 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 - October 2023
Trial Phase
2
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