GnRH therapy to improve cognition in individuals with Down syndrome
Effect of Pulsatile GnRH Therapy on Cognition in Down Syndrome: Randomized Placebo Control Study
This study is testing if a new hormone treatment can help improve thinking skills and smell in adults with Down syndrome who are at risk for early Alzheimer's disease.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 16 Years to 50 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Vaudois Academic / other |
| Locations | 1 site (Lausanne, Canton of Vaud) |
| Trial ID | NCT04390646 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with Down syndrome who are able to communicate and consent to participate.
Not a fit: Patients with acute illnesses, chronic substance abuse issues, or those taking certain hormonal medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel treatment option to improve cognitive and olfactory functions in adults with Down syndrome.
How similar studies have performed: While there is limited research on GnRH therapy specifically for Down syndrome, similar approaches targeting cognitive decline in other populations have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lausanne, Canton of Vaud
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.