Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Donanemab for Alzheimer Disease

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.

Official registry: https://clinicaltrials.gov/study/NCT07602582 · Eli Lilly and Company · enrollment listed as 550

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Donanemab, or Placebo. The registry lists allocation as randomized. The main purpose of this study is to determine if participants who previously took donanemab get clinical benefit when they receive annual doses.

They plan to enroll about 550 people at 62 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Donanemab, Placebo

Primary outcome (registry wording): Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB)

Who it is for (from inclusion criteria)

  • Ages 55 Years to any
  • 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

Public study contact (from the registry)

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

LillyTrials@Lilly.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

62 listed

+ 7 sites outside the US on the same record

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The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2.

NCT02649985 · Official ClinicalTrials.gov record · Brigham and Women's Hospital

FAQ about this NCT record

Is NCT07602582 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07602582?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07602582?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary