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Be Part of Research - Trial Details - AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid
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AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid

Not Recruiting

Open to: ALL

Age: 55.0 - 80.0

London Bristol Glasgow London

Medical Conditions

Alzheimer Disease
Amyloidosis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). This study will also evaluate the long-term safety and tolerability of lecanemab in participants enrolled in the Extension Phase.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jul 2020 Dec 2028

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : IV infusion.

Intervention Arm Group : A3 Trial: Lecanemab 10 mg/kg (Extension Phase);A3 Trial: Lecanemab 5 mg/kg + 10 mg/kg (Core Study);A45 Trial: Lecanemab 10 mg/kg (Extension Phase);A45 Trial: Lecanemab 5 mg/kg + 10 mg/kg (Core Study);

Intervention Type : DRUG
Intervention Description : IV infusion.

Intervention Arm Group : A3 Trial: Placebo (Core Study);A45 Trial: Placebo (Core Study);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • St Pancras Clinical Research
    London
    EC2Y 8EA
  • Bristol Brain Centre
    Bristol
    BS10 5NB
  • Glasgow Memory Clinic
    Glasgow
    ML1 4UF
  • Imperial Memory Unit
    London
    W6 8RF


The study is sponsored by Eisai Inc. and is in collaboration with Alzheimer's Clinical Trials Consortium; Biogen; National Institute on Aging (NIA).



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Read full details for Trial ID: NCT04468659
Last updated 31 December 2024

This page is to help you find out about a research study and if you may be able to take part

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