ELAD study
Research type
Research Study
Full title
Evaluating the effects of the novel GLP-1 analogue, liraglutide, in patients with Alzheimer’s disease (ELAD study)
IRAS ID
109089
Contact name
Paul Edison
Contact email
Sponsor organisation
Imperial College London
Eudract number
2013-000962-13
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
WHO, U1111-1131-9252
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
This is a 12-month, multicentre randomised double-blind placebo-controlled Phase IIb study in patients with mild Alzheimer’s dementia (AD). We aim to recruit patients with mild Alzheimer’s dementia as defined by the National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA) Criteria for Probable Alzheimer’s Dementia or meeting Dubois criteria for early AD, with Mini Mental State Evaluation score of at least 22 out of a maximum of 30 and a CDR Global score of 0.5 or 1 using the University of Washington on-line algorithm.
Patients will be randomised on a 1:1 ratio to receive liraglutide (1.8 mg daily by subcutaneous injection) or identical matching placebo. Liraglutide is marketed for use in patients with type 2 diabetes to reduce hyperglycaemia by increasing insulin secretion, but its specific mechanism of action does not cause hypoglycaemia in non-diabetic subjects. Since type 2 diabetes is a risk factor for AD, this study aims to investigate whether liraglutide has any effect on the glucose metabolism in the brains of patients with mild AD. This will be studied using [18F]FDG-PET imaging at baseline and after 12 months to determine whether there is any difference between liraglutide-treated subjects and those receiving placebo. Subjects will also have brain scans using MRI at baseline and after 12 months of treatment.
REC name
London - Riverside Research Ethics Committee
REC reference
13/LO/0699
Date of REC Opinion
6 Sep 2013
REC opinion
Further Information Favourable Opinion