Cognitive Dysfunction and Glucagon-like Peptide-1 Agonists

What Was Tested

This registered phase 3 trial tested Liraglutide.

Cognitive deficits are a core feature across disparate brain disorders, being highly prevalent and pervasive.

Impairments in executive function are one of the most consistent findings in clinical and meta-analytical studies and were reported to be a principal mediator of psychosocial impairment and disability.

Cognitive dysfunction is thought to be underlied by abnormalities in distributed brain circuits, at the cellular and molecular levels.

It had two arms (groups): Insulin Resistance (active comparator) and Non-Insulin Resistance (active comparator).

The registry classes the interventions as biological.

More on the Plan

The researchers propose to explore the effects of GLP-1 agonism on brain structure and function.

The researchers are currently not in a position to sufficiently homogenize subgroups of adults with mood disorder on the basis of any single or combinatorial biomarkers.

It is also unlikely that alterations in GLP-1 receptor function, and the proposed model herein, is sufficiently explanatory to all sub-populations of adults with mood disorders.

Instead, the researchers propose that adults with mood disorders, who have co-existing metabolic disorders (e.g. type 2 diabetes mellitus), would be more likely to have a brain illness that is influenced by (i.e. cause, consequence or both) alterations in cellular bioenergetics.

Who Took Part

21 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: Informed consent before study-related activity. Individuals between the ages of 18 and 45 who meet DSM-5 criteria for bipolar disorders or depressive disorders. Below-average (i.e. 1 standard deviation below norm) performance in the TMTB.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: diagnosis of possible or probable ad, mci, or any other dementia; actively suicidal or evaluated as being a suicide risk (operationalized as a score of ≥3 on hamd-17 suicide item and/or by clinical assessment); substance use disorder within 3 months before screening or a positive baseline toxicology screen.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Being open-label, the Liraglutide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2015-05 with completion listed for 2016-04.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Executive function (time frame: 4 weeks).

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Liraglutide in 21 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.