Study E2814-G000-103

• Research type

  Research Study

• Full title

  An Open-Label Phase 1b/2 Study to Assess Safety and Target Engagement of E2814 in Subjects with Mild to Moderate Cognitive Impairment due to Dominantly Inherited Alzheimer’s Disease

• IRAS ID

  296530

• Contact name

  Catherine Mummery

• Contact email

  cath.mummery@nhs.net

• Sponsor organisation

  Eisai Ltd.

• Eudract number

  2020-005728-12

• Clinicaltrials.gov Identifier

  NCT04971733

• Duration of Study in the UK

  years, 33 months, days

• Research summary

  Research Summary:

  This study is an Open-Label (a clinical trial in which doctors and participants know which drug is being administered) Phase 1b/2 Study to Assess Safety (symptoms and medical problems participants may experience - known as side effects) and Target Engagement (how well the study drug interacts with tau protein) of E2814 in Subjects with Mild to Moderate Cognitive Impairment (capacity for judgment and reasoning) due to Dominantly Inherited Alzheimer’s Disease.

  E2814 is an investigational study drug. The study drug will be administered by slow injection of a substance through the vein (intravenous infusion).

  Eisai is testing the study drug (E2814) for treating Alzheimer’s Disease, a disease that damages brain cells. Accumulation of protein deposits (plaques) of a substance called Tau Neurofibrillary tangles (NFTs) in the brain cells may cause this disease. These plaques are formed when a protein called tau starts to behave abnormally within brain cells. E2814 is a novel immunoglobulin monoclonal antibody (mAb) that binds to tau protein to inhibit further tau aggregation and accelerate its clearance.

  There has been one other study of E2814 in about 32 healthy subjects to date.

  Approximately 8 subjects will take part in this study in about 3 research centres in United Kingdom and United States.

  The duration of the study will be up 31 months to complete.
  Study will consist of 2 phases – A Screening Phase and a Treatment Phase (consisting of 3 periods: 1b, 2, and follow up):
  1. Screening Period: approximately 8 weeks
  2. Treatment Phase: approximately 120 weeks
  2.1. Phase 1b Treatment Period: 12 weeks
  2.2. Phase 2 Treatment Period: 96 weeks
  2.3. Post-Treatment Follow-up Period: 12 weeks

  Summary of results:

  A copy of the Lay summary of results will be made available on https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Feisaiclinicaltrials.com%252F.%2FNBTI%2FUoi9AQ%2FAQ%2F1eb520e4-b0ae-467d-a1c4-1bd68ffc471b%2F2%2FPpTkMz807M&data=05%7C02%7Cleedseast.rec%40hra.nhs.uk%7Ce4129e06dd3f47104a9708dd9a15590d%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638836138660188135%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Yh3d%2FQL2HN%2FxqtJ1KbNn9rOEIRDHxKbKptL7tixYq5A%3D&reserved=0

  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT04971733%253Fterm%253DE2814-G000-103%2526rank%253D1%2FNBTI%2FUoi9AQ%2FAQ%2F1eb520e4-b0ae-467d-a1c4-1bd68ffc471b%2F1%2FKnPDuQpaK0&data=05%7C02%7Cleedseast.rec%40hra.nhs.uk%7Ce4129e06dd3f47104a9708dd9a15590d%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638836138660206229%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=a%2FR3N%2FisflbJc%2FN3u2TLxINv7u5zhNZS8ggz%2B0QggtU%3D&reserved=0

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  21/YH/0103

• Date of REC Opinion

  7 Jun 2021

• REC opinion

  Further Information Favourable Opinion