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Be Part of Research - Trial Details - A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease
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A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

Not Recruiting

Open to: ALL

Age: 50.0 - 90.0

London London Plymouth Southampton Sheffield Birmingham Guildford London

Medical Conditions

Early Alzheimer's Disease

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.


This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase. Extension Phase Part B will continue dosing with lecanemab in countries where lecanemab may not be commercially available.

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:

Mar 2019 Jun 2029

Publications

"Devanarayan V, Ye Y, Zhu L, Tian L, Kramer L, Irizarry M, Dhadda S. Predicted natural progression as an Alzheimer's prognostic covariate improves the precision of lecanemab efficacy assessments and clinical trial efficiency. Alzheimers Dement. 2025 Mar;21(3):e70045. doi: 10.1002/alz.70045."; "40042496"; "Devanarayan V, Charil A, Horie K, Doherty T, Llano DA, Andreozzi E, Sachdev P, Ye Y, Murali LK, Zhou J, Reyderman L, Hampel H, Kramer LD, Dhadda S, Irizarry MC; Alzheimer's Disease Neuroimaging Initiative (ADNI). Plasma pTau217 ratio predicts continuous regional brain tau accumulation in amyloid-positive early Alzheimer's disease. Alzheimers Dement. 2025 Feb;21(2):e14411. doi: 10.1002/alz.14411. Epub 2024 Nov 22."; "39575854"; "Devanarayan V, Doherty T, Charil A, Sachdev P, Ye Y, Murali LK, Llano DA, Zhou J, Reyderman L, Hampel H, Kramer LD, Dhadda S, Irizarry MC. Plasma pTau217 predicts continuous brain amyloid levels in preclinical and early Alzheimer's disease. Alzheimers Dement. 2024 Aug;20(8):5617-5628. doi: 10.1002/alz.14073. Epub 2024 Jun 28."; "38940656"; "Honig LS, Sabbagh MN, van Dyck CH, Sperling RA, Hersch S, Matta A, Giorgi L, Gee M, Kanekiyo M, Li D, Purcell D, Dhadda S, Irizarry M, Kramer L. Updated safety results from phase 3 lecanemab study in early Alzheimer's disease. Alzheimers Res Ther. 2024 May 10;16(1):105. doi: 10.1186/s13195-024-01441-8."; "38730496"; "Tahami Monfared AA, Ye W, Sardesai A, Folse H, Chavan A, Aruffo E, Zhang Q. A Path to Improved Alzheimer's Care: Simulating Long-Term Health Outcomes of Lecanemab in Early Alzheimer's Disease from the CLARITY AD Trial. Neurol Ther. 2023 Jun;12(3):863-881. doi: 10.1007/s40120-023-00473-w. Epub 2023 Apr 2."; "37009976"; "van Dyck CH, Swanson CJ, Aisen P, Bateman RJ, Chen C, Gee M, Kanekiyo M, Li D, Reyderman L, Cohen S, Froelich L, Katayama S, Sabbagh M, Vellas B, Watson D, Dhadda S, Irizarry M, Kramer LD, Iwatsubo T. Lecanemab in Early Alzheimer's Disease. N Engl J Med. 2023 Jan 5;388(1):9-21. doi: 10.1056/NEJMoa2212948. Epub 2022 Nov 29."; "36449413"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Administered as IV infusion.

Intervention Arm Group : Core Study: Lecanemab 10 mg/kg biweekly;Extension Phase B;Extension Phase: Lecanemab 10 mg/kg Intravenous Infusion Once Every 4 Weeks;Extension Phase: Lecanemab 10 mg/kg biweekly;

Intervention Type : DRUG
Intervention Description : Biweekly (once every 2 weeks) administered as intravenous infusion.

Intervention Arm Group : Core Study: Placebo;

Intervention Type : DRUG
Intervention Description : Administered weekly as a subcutaneous injection.

Intervention Arm Group : Extension Phase B;Extension Phase: Lecanemab Subcutaneous Injection Dose 1;Extension Phase: Lecanemab Subcutaneous Injection Dose 2;Extension Phase: Lecanemab Subcutaneous Injection Dose 3;Extension Phase: Lecanemab Subcutaneous Injection Dose 4;



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.

  • Charing Cross Hospital
    London
    W6 8RF
  • Re:Cognition Health Ltd
    London
    W1G 9JF
  • Re:Cognition Health
    Plymouth
    Devon
    PL6 8BT
  • Memory Assessment & Research Centre (MARC),
    Southampton
    Hampshire
    SO30 3JB
  • Sheffield Memory Service
    Sheffield
    South Yorkshire
    S5 7JT
  • Re:Cognition Health Ltd
    Birmingham
    B16 8LT
  • Re:Cognition Health Ltd
    Guildford
    GU2 7YD
  • St. Pancras Clinical Research
    London
    EC2Y 8 EA


The study is sponsored by Eisai Inc. and is in collaboration with Biogen.



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Read full details for Trial ID: NCT03887455
Last updated 10 October 2025

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