Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation
A Randomized, Double-Blind, Placebo-Controlled, Phase 4 Dose-Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Donanemab in Adults With Down Syndrome
Sponsor: Michael Rafii, MD, PhD + National Institute on Aging (NIA), Eli Lilly and Company
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Change from baseline on brain amyloid levels
Time frame: 12 months
Secondary Endpoints
Change from baseline to 12 months in the Modified Cued Recall Test (mCRT)
Change from baseline in whole brain volume
Change from baseline in brain hippocampal volume
Eligibility Criteria
Inclusion Criteria: 1. Documentation of the participant's informed consent to study procedures 2. Ages 35-50 years (inclusive). 3. Plasma Phosphorylated tau (pTau) 217 levels at screening consistent with amyloid PET eligibility. 4. Diagnosis of Down syndrome (including trisomy 21, mosaic trisomy 21, Robertsonian translocation trisomy 21, or partial trisomy 21) as confirmed by medical record review or Karyotype genetic testing. 5. Intelligence quotient (IQ) equal to or greater than 40 based on Kaufman Brief Intelligence Test, Second Edition. 6. Participants must be in good general health as evidenced by medical history with no diagnosis of dementia. 7. Elevated brain amyloid (\>18 centiloids) at screening. 8. Stable dose of permitted medications as described protocol for 4 weeks prior to screening. 9. In the opinion of the site PI, has a study partner able and willing to provide accurate information (including clinical symptoms and medical history) about the participant and participate…
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