Alzheimer Disease study: Donanemab
Official title A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).
ClinicalTrials.gov ID: NCT07602582
What this study is testing
What is Donanemab?
Donanemab is an investigational intravenous medicine being studied for Alzheimer disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether yearly doses of donanemab help people who have already taken it. It looks at how the drug works over time.
- Who it's for
- You may be able to join if you have Alzheimer’s disease and have already taken donanemab in a previous study.
- What's involved
- You will receive a yearly dose of donanemab and have 6 visits over the study. Each visit checks your health and records any changes.
- Time commitment
- The study lasts up to 2.5 years and includes 6 visits, about one every 4-5 months.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- Have completed study AACM Addendum 7.
- Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive...
- Are individuals assigned female at birth who are not of childbearing potential, or are individuals assigned male at birth.
- Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in...
You likely can't join if
- Current serious or unstable illnesses that, in the investigator's opinion, could interfere with participation in this study.
- Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic)...
- Have any intracranial abnormality or lesion, including but not limited to macrohemorrhage, inflammation, or structural findings that, in the opinion...
- Contraindication to florbetapir F 18 PET.
- Have had history of amyloid-targeting therapy treatment outside donanemab trials.
- Have participated, within the last 30 days, in a clinical trial involving a study intervention judged not to be scientifically or medically...
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Huntington Beach, California, United States
- Irvine, California, United States
- Long Beach, California, United States
- Riverside, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Santa Ana, California, United States
- Santa Rosa, California, United States
- Walnut Creek, California, United States
- Aventura, Florida, United States
- Bradenton, Florida, United States
- Clermont, Florida, United States
- Daytona Beach, Florida, United States
- Greenacres City, Florida, United States
- Jacksonville, Florida, United States
- Lady Lake, Florida, United States
- Maitland, Florida, United States
- Merritt Island, Florida, United States
- Miami, Florida, United States
+ 36 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Huntington Beach, California, United States; Irvine, California, United States; Long Beach, California, United States; Riverside, California, United States; Sacramento, California, United States and 50 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.