Safety and Efficacy of Liraglutide in Parkinson's Disease

What Was Tested

This registered phase 2 trial tested Liraglutide for parkinson's disease.

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

Placebo will be self-administered subcutaneously once daily according to the same schedule.

The registry classes the interventions as drug.

More on the Plan

Liraglutide has been approved by the Food and Drug Administration (FDA) to treat adults with Type 2 Diabetes (T2D) and to treat obesity, but it is considered investigational in this study, as it has not been approved for use in patients with PD.

Indeed, impaired insulin signaling in the brain can cause or exacerbate many brain pathologies and behavioral abnormalities seen in PD.

Eligible participants will be followed for up to 14 months and will be expected to complete 9 in-person visits and 2 telephone visits.

The study will measure liraglutide effects on motor (assessed by changes in the MDS-UPDRS part III) and non-motor symptoms of PD (assessed by the NMSS and MDRS-2) after 52 weeks of treatment.

Who Took Part

63 actual participants took part.

It was open to people of any sex aged from 25 years up to 85 years.

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

Examples of who could join: Responsive to levodopa or dopaminergic treatment. Male or female between 25 and 85 years of age at time of enrollment. Male patients with female partners who have child bearing potential must agree to use adequate contraception throughout the duration of the trial period. Capacity to give informed consent. Ability to self-administer, or to arrange a care partner to administer trial drug, to comply with trial protocol, and to attend necessary clinic visits off medication.

The full record lists 7 inclusion and 24 exclusion criteria; among the exclusions: active treatment with anticholinergic medications (e.g., trihexyphenidyl, tricyclic antidepressants); concurrent dementia defined by a score lower than 120 on the madrs-2 and/or inability to complete scale per neuropsychologist discretion; concurrent severe depression defined by a score greater than 29 on the beck depression inventory.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Liraglutide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the parkinson's disease participants and researchers unaware of who received Liraglutide.

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

It started in 2017-04-03 with completion listed for 2022-08-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in the Non-Motor Symptoms Scale (NMSS) Total Score From Baseline to the End of the Double-Blind Maintenance Period (time frame: From Baseline (Week 0) to the End of Maintenance Period (up to Week 54)). Change in the Mattis Dementia Rating Scale (DRS-2) From Baseline to the End of Double-Blind Maintenance Period (time frame: From Baseline (Week 0) to the end of Maintenance Period (up to 54 weeks)).

It also tracked 3 secondary outcomes, for example Change in the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Index From Baseline to the End of Maintenance Period.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 63 people with parkinson's disease.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, Parkinson's disease research.