Recruiting PHASE3 Alzheimer Disease

New treatment option for Alzheimer Disease

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 medicine, given as an infusion into a vein, being studied as a potential treatment 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
The main purpose of this study is to determine if participants who previously took donanemab get clinical benefit when they receive annual doses. For each participant, the study will last up to 2.5 years and will include 6 visits.
  • 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's taking place

  • 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
  • Greenacres City, Florida, United States
  • Jacksonville, Florida, United States
  • Maitland, Florida, United States
  • Merritt Island, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Mt. Dora, Florida, United States
  • New Port Richey, Florida, United States

+ 35 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 - 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?

Study sites include 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 49 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.