GnRH therapy to improve cognition in individuals with Down syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of GnRH therapy on cognitive decline and olfactory disorders in adults with Down syndrome. The study aims to evaluate whether pulsatile administration of GnRH can enhance cognitive function and olfactory abilities in this population, who are at increased risk for early-onset Alzheimer's disease. Participants will receive either GnRH or a placebo, and their cognitive and olfactory functions will be assessed throughout the trial. The study targets individuals diagnosed with trisomy 21 who can provide verbal consent and follow study procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of trisomy 21
* Verbal expression (ability to follow the procedures of the study)
* Consent to a non-hormonal contraception during the whole duration of the study For women: intra-uterine device with copper, a prior tubal ligation or condoms for the partner For men: condoms or vasectomy

Exclusion Criteria:

* Acute illness (clinical or biochemical findings suggesting acute illness/hospitalization)
* 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
* Participation in another clinical study
* Intention to become a parent during the course of the study
* Females: ovarian cysts, non-hypothalamic anovulation (i.e. polycystic ovary syndrome), pregnancy or lactation
* Males: hematocrit \> 54%
* Contraindications for MRI (e.g. pacemaker, metal clips,etc)
* Participant or his/her legal representative do not want to be informed in case of incidental findings

Where it's running

• Centre Hospitalier Universitaire Vaudois (CHUV)
  Lausanne, Canton of Vaud, Switzerland Recruiting

Study contacts

• Principal investigator: Nelly Pitteloud, MD — Endocrinology, Metabolism, Diabetology (CHUV)
• Study coordinator: Pulse-UP study
• Email: pulseup@chuv.ch
• Phone: +41 21 314 06 25

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.