Evaluating Liraglutide in Alzheimer's Disease

What Was Tested

The trial (phase 2) is built around Liraglutide.

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.

It had two arms (groups): Liraglutide (experimental) and Placebo (placebo comparator).

Daily administration of matched placebo by subcutaneous injection.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 204 actual participants took part.

It was open to people of any sex aged from 50 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Capable of giving and capacity to give informed consent. Age from 50 years. Rosen Modified Hachinski Ischemic score ≤4. On stable medication for 2 months before the screening visit; on or off cholinesterase inhibitors. Fluency in English and evidence of adequate premorbid intellectual functioning.

The full record lists 9 inclusion and 17 exclusion criteria; among the exclusions: patients on treatment for diabetes mellitus; MRI/CT showing unambiguous aetiological evidence of cerebrovascular disease with regard to their dementia or vascular dementia fulfilling NINCDS-AIREN criteria; history of epilepsy, where seizures or treatment could have contributed to cognitive impairment.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2014-01 with completion listed for 2019-12.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The change in cerebral glucose metabolic rate (time frame: 12 months).

It also tracked 5 secondary outcomes, for example The change in z-scores for the ADAS Exec, MRI changes, microglial activation, and CSF markers, The incidence and severity of treatment emergent adverse events, The change in microglial activation, The change in tau deposition and The change in cortical amyloid.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 204 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.