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 22 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 identical matching placebo.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- The incidence and severity of treatment emergent adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]The incidence and severity of treatment emergent adverse events or clinically important changes in safety assessments over 12 months.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Daily administration of 1.8 mg liraglutide by subcutaneous injection
Other Name: Victoza
Placebo Comparator: Placebo
Daily administration of matched placebo by subcutaneous injection
Please refer to this study by its ClinicalTrials.gov identifier: NCT01843075
|Contact: Paul Edison, MBBS PhD FRCPI||+44 (0) firstname.lastname@example.org|
|Contact: Vicky Tsipouri, PhDemail@example.com|
|Imperial College, Hammersmith Hospital||Recruiting|
|London, United Kingdom, W12 0NN|
|Contact: Vicky Tsipouri, PhD firstname.lastname@example.org|
|Principal Investigator: Paul Edison, PhD FRCP(I)|
|Principal Investigator:||Paul Edison, MBBS, PhD, FRCPI||Imperial College London|