GnRH Therapy on Cognition in Down Syndrome

What Was Tested

The trial (phase 2, phase 3) is built around Gonadorelin.

DS individuals already show AD neuropathology by the age of 30, while it becomes clinically recognized in their late forties.

It had two arms (groups): Pulsatile GnRH pump treatment (active comparator) and Pulsatile placebo pump treatment (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 56 planned participants were the target.

It was open to people of any sex aged from 16 years up to 50 years.

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

Examples of who could join: Diagnosis of trisomy 21. Verbal expression (ability to follow the procedures of the study).

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: chronic alcohol abuse, illicit drug use, anabolic steroid abuse, psychotropic drugs reported by caregivers; taking medication that modifies hormones: spironolactone, ketoconazole, anticoagulants, corticosteroids, acth hormone, psychotropics, including antidepressants, antipsychotics and anticonvulsants; known pituitary adenoma and other hormone-dependent tumours.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

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

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

Neither the participants nor the staff measuring them knew who was on Gonadorelin, so expectations could not easily colour the readings.

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

It started in 2020-08-27 with completion listed for 2028-12.

It ran at 1 site in Switzerland.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Cognition (time frame: Baseline to end of treatment (Week 24)).

It also tracked 13 secondary outcomes, for example Dimensional change card sorting task (DCCS), Paired Associated Learning (PAL, part of the CANTAB battery), Token test, Corsi block tapping task, Litmus non-word-repetition test and Health-related quality of life SF-12.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Gonadorelin in 56 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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