This is a 12-month, multicentre randomised double-blind placebo-controlled Phase IIb study in patients with mild Alzheimer's dementia (AD). Patients will be randomised on a 1:1 ratio to receive liraglutide or matching placebo.
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. .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
204
Daily subcutaneous injection
Daily subcutaneous injection
Imperial College, Hammersmith Hospital
London, United Kingdom
The change in cerebral glucose metabolic rate
The change in cerebral glucose metabolic rate from baseline to follow up (12 months) in the treatment group compared with the placebo group.
Time frame: 12 months
The change in z-scores for the ADAS Exec, MRI changes, microglial activation, and CSF markers
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
The incidence and severity of treatment emergent adverse events or clinically important changes in safety assessments over 12 months.
Time frame: 12 months
The change in microglial activation
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
Time frame: 12 months
The change in tau deposition
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.
Time frame: 12 months
The change in cortical amyloid
Changes in levels of cortical amyloid load in treatment group compared to the placebo group in a subgroup of subjects.
Time frame: 12 months
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