Evaluating Liraglutide in Alzheimer's Disease (ELAD)
This is a 12-month, multicentre randomised double-blind placebo-controlled Phase IIb study in patients with mild Alzheimer's dementia (AD). The investigators 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 20 out of a maximum of 30 and a CDR Global score of 0.5 or 1.
Patients will be randomised on a 1:1 ratio to receive liraglutide or matching placebo.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
|Official Title:||Evaluating the Effects of the Novel GLP-1 Analogue, Liraglutide, in Patients With Mild Alzheimer's Disease (ELAD Study)|
- The change in cerebral glucose metabolic rate [ Time Frame: 12 months ]The change in cerebral glucose metabolic rate from baseline to follow up (12 months) in the treatment group compared with the placebo group.
- The change in z-scores for the ADAS Exec, MRI changes, microglial activation, and CSF markers [ Time Frame: 12 months ]
- The incidence and severity of treatment emergent adverse events [ Time Frame: 12 months ]The incidence and severity of treatment emergent adverse events or clinically important changes in safety assessments over 12 months.
- The change in microglial activation [ Time Frame: 12 months ]To establish whether there is a reduction in microglial activation in subjects with mild AD following daily subcutaneous injection of liraglutide for 1 year using TSPO PET scanning compared with subjects receiving placebo injections in a subgroup of patients
- The change in tau deposition [ Time Frame: 12 months ]The change in the hippocampal, entorhinal and other cortical changes in tau deposition in treatment group compared to the placebo group in a subgroup of subjects.
- The change in cortical amyloid [ Time Frame: 12 months ]Changes in levels of cortical amyloid load in treatment group compared to the placebo group in a subgroup of subjects.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||March 2019|
|Estimated Primary Completion Date:||March 2019 (Final data collection date for primary outcome measure)|
Daily administration of 1.8 mg liraglutide by subcutaneous injection
Daily subcutaneous injection
Other Name: Victoza
Placebo Comparator: Placebo
Daily administration of matched placebo by subcutaneous injection
Daily subcutaneous injection
Please refer to this study by its ClinicalTrials.gov identifier: NCT01843075
|Contact: Paul Edison, PhD FRCPI||+44 (0) firstname.lastname@example.org|
|Contact: Victoria Scott, BSc||+44 (0) email@example.com|
|Imperial College, Hammersmith Hospital||Recruiting|
|London, United Kingdom, W12 0NN|
|Contact: Victoria Scott, BSc +44 (0) 283833704 firstname.lastname@example.org|
|Principal Investigator: Paul Edison, PhD FRCP(I)|
|Principal Investigator:||Paul Edison, PhD FRCPI||Imperial College London|