RightFit
RecruitingPhase 3

A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).

An Annual Dosing Study of Donanemab in Participants Who Completed Donanemab Study AACM

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 6 visits

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "For each participant, the study will last up to 2.5 years and will include 6 visits."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * 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 abilities. * 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 clinical studies. Exclusion Criteria: * 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) implants/cardiac pacemaker. * Have any intracranial abnormality or lesion, including but not limited to macrohemorrhage, inflammation, or structural findings that, in the opinion of the investigator, may pose an unacceptable safety risk to the participant. Screening MRI finding of amyloid-related imaging abnormalities with edema (ARIA-E) may be monitored for resolution. * 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 compatible with this study.

Study sites (52)

AZ

CA

FL

GA

IA

ID

IL

IN

LA

MA

MI

MO

NC

NJ

  • The Cognitive and Research Center of New Jersey · Springfield, NJ 07081Raminder Parihar · Principal investigatorMore trials in Springfield

NV

OH

TX

WA