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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
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jul 28, 2026
Report code
NCT06996730-Jul 28, 2026
NCT ID
NCT06996730
Status
NOT_YET_RECRUITING
Phase
Phase 2/3
Sponsor
Banner Health
Executive brief
Investment-Ready Snapshot
This clinical trial, sponsored by Banner Health, investigates the efficacy and safety of donanemab and RG6289 in treating Autosomal-Dominant Alzheimer's Disease (ADAD) in PSEN1 E280A mutation carriers. The trial's dual approach—targeting both amyloid and tau—positions it strategically in the competitive landscape of Alzheimer's therapeutics, where combination therapies are gaining traction. The estimated enrollment of 240 participants and the involvement of notable collaborators, including the National Institute on Aging, enhance the study's credibility. The trial's outcomes could significantly influence market dynamics, particularly if positive results are achieved, potentially leading to a first-in-class combination therapy for ADAD.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT06996730
Indication
Autosomal Dominant Alzheimers Disease
Modality
small molecule
Target
Donanemab targets amyloid-beta plaques in the brain, while RG6289 is an oral small molecule that modulates tau pathology. The combination aims to address both amyloid and tau pathologies in Alzheimer's Disease.
Intervention
Donanemab, RG6289, Donanemab placebo, RG6289 placebo
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.