RecruitingPhase 2 / Phase 3interventionalRules rewrite

Phase 2 / Phase 3: testing Donanemab for Autosomal Dominant Alzheimers Disease

The study will be conducted in 2 blinded parts (Part 1 and Part 2). In Part 1, study participants who are mutation carriers will receive active donanemab and non-mutation carriers will receive dummy treatment (placebo)-donanemab for up to 18 months (76 weeks), with a minimum treatment period of 9 months.

Official registry: https://clinicaltrials.gov/study/NCT06996730 · Banner Health · enrollment listed as 240

What this phase means

Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.

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, RG6289, or Donanemab placebo. The registry lists allocation as randomized. The study will be conducted in 2 blinded parts (Part 1 and Part 2).

They plan to enroll about 240 people at Medellín. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Double-Blind, Placebo-Controlled, Double-Dummy Study of Donanemab and RG6289 in PSEN1 E280A Mutation Carriers, and in Non-Randomized, Placebo-Treated Non-Carriers From the Same Kindred, to Evaluate the Efficacy and Safety of Donanemab, RG6289, or the Combination of Donanemab and RG6289, in the Treatment of Autosomal-Dominant Alzheimer's Disease

Interventions: Donanemab, RG6289, Donanemab placebo, RG6289 placebo

Primary outcome (registry wording): Part 1: Change in amyloid load as measured by centiloid (CL) [F18]Florbetapir-PET as biomarker endpoint

Who it is for (from inclusion criteria)

Ages 25 Years to 65 Years
Membership in PSEN1 E280A mutation carrier kindred
Agrees to conditions of, and is willing to undergo, genetic testing (e.g., APOE, PSEN1 E280A, and other genetic testing allowed by local regulatory requirements)
Males and females aged 25-65 inclusive
Must meet one of the following criteria:
a. Determined to be cognitively normal as defined by an MMSE of ≥24 for participants with less than 9 years of education or MMSE of ≥26 for participants with 9 or more years of education. b. Or determined to have MCI with amnestic presentation as defined by:
Meets the 2011 National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable AD, and
Has a CDR-GS of 0.5 or 1, with the memory box score ≥0.5

Who the registry excludes

Significant medical, psychiatric, or other neurological condition or disorder documented by history, physical, neurological, laboratory examinations that would place the participant at undue risk in the Investigator's judgment or impact the interpretation of how well it works
History of severe, clinically significant (persistent neurological deficit or structural brain damage) CNS trauma (e.g., cerebral contusion)
Women who are pregnant or intend to become pregnant during the conduct of this study
Women who are nursing infants or intend to nurse infants during the conduct of this study
Known (or prior) hypersensitivity to donanemab, RG6289, or any excipients of RG6289
History of or active inflammatory bowel disease (e.g., Crohn disease or ulcerative colitis)
Medical history of malignancy in the past 5 years, with the following exceptions:

Public study contact (from the registry)

David Gordon, M.S.

(602) 839 - 6020

David.Gordon@bannerhealth.com

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

Sites listed on ClinicalTrials.gov

1 listed

Neurosciences Group of Antioquia, University of Antioquia — Medellín, Antioquia, Colombia (recruiting)

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FAQ about this NCT record

Is NCT06996730 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 NCT06996730?

Phase 2 / 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 NCT06996730?

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