Identifying Potential Effects of Liraglutide on Degenerative Changes

What Was Tested

The trial (not phased) is built around Liraglutide.

It had two arms (groups): Drug (active comparator) and placebo (placebo comparator).

Non active intervention.

The registry classes the interventions as drug.

More on the Plan

DM-2 is a risk factor for both AD and vascular dementia.

The understanding of the underlying mechanism behind this linkage is so far very sparse.

In both diseases premature cell degeneration develops.

General metabolic risk factors such as hyperglycemia and hypercholesterolemia are evident in both diseases.

Who Took Part

The registry lists 34 actual participants took part.

It was open to people of any sex aged from 50 years up to 80 years.

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

Examples of who could join: Informed consent before study-related activity. Adult competent persons. Age ≥ 50 years and ≤ 80 years.

The full record lists 5 inclusion and 21 exclusion criteria; among the exclusions: diabetes mellitus; other clinically relevant abnormal biochemical value; current or former presence of one of the following diseases with clinical relevance:.

How the Study Was Run

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

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

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

It started in 2012-01 with completion listed for 2013-04.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: PIB PET scan (time frame: PIB PET-scan at baseline and after 26 weeks).

It also tracked 2 secondary outcomes, for example Neuro-psychological tests and FDG PET Scan.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 34 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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