Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

X
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

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Donanemab (Primary) ; LY 3202626 (Primary)
  • Indications Alzheimer's disease
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Acronyms TRAILBLAZER-ALZ
  • 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.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top