Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 1, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Down Syndrome (DS)Down Syndrome (Trisomy 21)Alzheimer DiseaseAmyloid Beta Protein
Interventions
DRUG

Donanemab

Donanemab will be administered as an IV infusion every 4 weeks using an up-titration regimen that will allow participants to reach a target dose of 1400 mg within 24 weeks.

DRUG

Placebo

The control product (placebo) will be supplied in vials containing 350 mg/20 mL of donanemab Placebo for donanemab is supplied to the clinical site to match the active study intervention and contains only inactive ingredients. Normal sterile saline solution (0.9% sodium chloride) will be used for dilution.

All Listed Sponsors
collaborator

National Institute on Aging (NIA)

NIH

collaborator

Eli Lilly and Company

INDUSTRY

collaborator

Alzheimer's Clinical Trials Consortium

OTHER

collaborator

Alzheimer's Therapeutic Research Institute

OTHER

lead

Michael Rafii, MD, PhD

OTHER