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A Single- and Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Intravenous Doses of LY3002813 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease

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Trial Profile

A Single- and Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Intravenous Doses of LY3002813 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Oct 2024

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At a glance

  • Drugs Donanemab (Primary)
  • Indications Alzheimer's disease
  • Focus Pharmacodynamics
  • Sponsors Eli Lilly and Company; Eli Lilly and Company (India) Pvt. Ltd

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.
  • 03 Sep 2019 Status changed from active, no longer recruiting to completed.

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