Efficacy and Safety of E2609 in Subjects with Alzheimer’s Disease

• Research type

  Research Study

• Full title

  A Placebo-Controlled, Double-Blind, Parallel-Group, 24-Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects with Early Alzheimer’s Disease

• IRAS ID

  220303

• Contact name

  Ashley Baldwin

• Contact email

  ashley.baldwin@5bp.nhs.uk

• Sponsor organisation

  Eisai Ltd

• Eudract number

  2016-003928-23

• Clinicaltrials.gov Identifier

  109308, IND

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  This is a Placebo-Controlled, Double-Blind, Parallel-Group study designed to study to Evaluate the Efficacy and Safety of study drug Elenbecestat E2609 in Subjects with Early Alzheimer’s Disease.

  The purpose of this research is to find out if Elenbecestat (E2609) has a benefit on a person’s thinking and memory and the ability to independently perform daily tasks. The studies will aim to assess this by also finding out if Elenbecestat (E2609) is safe and well tolerated in people with Early Alzheimer’s disease.

  The study period for an individual subject is 29 months; this includes a 2 month screening period, 24 months of
  treatment, and 3 months of post-treatment follow-up in the core study period.
  There will also be two optional biomarker sub studies available for patients to consent to if they wish. The biomarker sub studies will evaluate the effects of study treatment on the underlying pathophysiology of Alzheimer’s Disease using two methods.

  The first method is an amyloid Positron Emission Tomography scan (PET) scan. The PET scan can show how body tissues and brain are working, as well as what they look like.

  The second method used for the biomarker sub study is a Cerebral Spinal Fluid (CSF) Test. The test is conducted to look at the fluid that surrounds the brain and spinal cord.

  Should patients decide to not consent to the either of the sub studies, it will not affect their participation in the Main/core study.

  It is expected that approximately, 1330 subjects will be randomised into the study in approximately 350 sites, globally.There are approximately 25 sites planned for the UK.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  17/WM/0146

• Date of REC Opinion

  11 Aug 2017

• REC opinion

  Further Information Favourable Opinion