A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants with Early Cognitive Decline, at Least One Core Clinical Feature of Dementia with Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-Pathology
Investigating the Safety and Efficacy of an Investigational Medication in Early Alzheimer's Disease
Jared Brosch, MD
Primary Investigator
Brief description of study
TRAILBLAZER-ALZ 2 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of N3pG antibody (donanemab) in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) with the presence of brain amyloid and tau pathology.The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease.
Detailed description of study
Following the double-blind 76-week main study period, a double-blind 78-week long-term extension period is added to further evaluate donanemab efficacy and safety over time. Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab.
Trial participants who were dosed with donanemab in the main study will be enrolled to a 3-year follow up addendum. No study drug will be administered during this follow up. Participants from the addendum safety cohort are not eligible for the extension period.
Participants previously dosed with donanemab in the main study will be monitored to track re-accumulation of amyloid plaque for 3 years.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Alzheimer Disease
-
Age: 60 years - 85 years
-
Gender: All
Inclusion Criteria:
- Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months
- MMSE score of 20 to 28 (inclusive) at baseline
- Meet 18F flortaucipir PET scan (central read) criteria - does not apply to safety cohort
- Meet 18F florbetapir PET scan (central read) criteria
- Have a study partner who will provide written informed consent to participate
Exclusion Criteria:
- Contraindication to MRI or PET scans
- Current treatment with immunoglobulin G (IgG) therapy
The purpose of this study is to investigate the safety and efficacy of an investigational medication in people with early Alzheimer's disease, which is a condition affecting memory and cognitive function. Alzheimer's disease is characterized by the presence of amyloid plaques and tau tangles in the brain, which can lead to symptoms like memory loss and confusion.
Participants will undergo various procedures, including brain scans to detect amyloid and tau pathology. The study involves a double-blind period where some participants receive the investigational medication while others receive a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. Following this, there is an extension period where all participants may receive the investigational medication to further evaluate its effects.
- Who can participate: Adults with a gradual and progressive change in memory function for at least 6 months, and an MMSE score between 20 and 28, may qualify. Participants need to meet specific brain scan criteria and have a study partner who consents to participate.
- Study details: Participants will take part in a double-blind study where they may receive the investigational medication or a placebo. Brain scans will be used to monitor changes, and participants must meet specific brain scan criteria. They may continue in an extension period where they receive the investigational medication.
Interested in the study?
This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.
Please choose between Voice or SMS based delivery of verification code
or