Status:
RECRUITING
GnRH Therapy on Cognition in Down Syndrome
Lead Sponsor:
Nelly Pitteloud
Conditions:
Down Syndrome
Cognitive Decline
Eligibility:
All Genders
16-50 years
Phase:
PHASE2
PHASE3
Brief Summary
Down syndrome (DS) is the most common chromosomal disorder; with the increasing life expectancy, about 80% of DS adults reach age 65 years old. Early Alzheimer's disease (AD) is the most common cause ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04390646
Start Date
August 27 2020
End Date
December 1 2028
Last Update
February 12 2024
Active Locations (1)
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1
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011