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Assessment of Safety, Tolerability and Efficacy of LY3002813 in Early Symptomatic Alzheimer's Disease

Trial Profile

Assessment of Safety, Tolerability and Efficacy of LY3002813 in Early Symptomatic Alzheimer's Disease

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 24 Jul 2024

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At a glance

  • Drugs Donanemab (Primary) ; LY 3202626 (Primary)
  • Indications Alzheimer's disease
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Sponsors Eli Lilly and Company
  • Most Recent Events

    • 20 Jul 2023 Results (n=46) assessing the longer-term effect of donanemab on brain amyloid deposition by evaluating the amyloid re-accumulation observed in trial participants who reached clearance and were no longer receiving donanemab infusions, and compare it with amyloid accumulation for untreated amyloid-negative participants from NCT02624778, NCT03367403 and NCT04640077 studies, presented at the Alzheimer's Association International Conference 2023.
    • 18 Feb 2023 Results assessing to characterize the population pharmacokinetics of donanemab, the relationship between donanemab exposure and amyloid plaque reduction (response), and the relationship between donanemab exposure and amyloid-related imaging abnormalities with edema or effusions (ARIA-E) from NCT03367403 and NCT02624778 studies, published in the Clinical Pharmacology and Therapeutics.
    • 20 Jan 2023 According to an Eli Lilly and Company media release, the FDA has issued a complete response letter, meaning it has not granted accelerated approval for amyloid-clearing antibody donanemab. The FDA decision was due to the limited number of patients who stayed on the drug for at least 12 months, which is the timeframe the agency wants to see to assess the drug's safety. The company's plans are to file phase 3 clinical trial data later this year for a traditional, or full, FDA approval.
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