NCT04390646 · Phase 2 · RECRUITING
GnRH Therapy on Cognition in Down Syndrome
This trial tests whether gonadorelin, a lab-made version of the brain hormone GnRH, can improve thinking and sense of smell in people with Down syndrome, compared with a saltwater placebo. It is a Phase 2 trial, meaning researchers are testing whether it works and is safe, not yet proven or approved. The idea comes from earlier mouse studies.
You may qualify if
- 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
You're excluded if
- 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-02-12