GnRH replacement rescues cognition in Down syndrome.
Maria Manfredi-Lozano, Valerie Leysen, Michela Adamo...
https://pubmed.ncbi.nlm.nih.gov/36048943Actively Recruiting
Phase 2
Phase 3
Age: 16Years - 50Years
All Genders
ID04390646
Effect of Pulsatile GnRH Therapy on Cognition in Down Syndrome: Randomized Placebo-Controlled Study
Led by Nelly Pitteloud · Updated on 2024-02-12
56
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Down syndrome (DS) is the most common chromosomal disorder, with many adults living to age 65. Early Alzheimer's disease (AD) is the leading cause of death in this group. Individuals with DS show AD-related brain changes by age 30 and develop clinical symptoms in their late 40s. They also experience problems with their sense of smell. Currently, no treatments address these cognitive or olfactory difficulties in DS. Researchers are studying a treatment using pulsatile gonadotropin-releasing hormone (GnRH), a natural hormone involved in reproduction and brain functions. This study compares pulsatile GnRH therapy delivered through a subcutaneous pump with a placebo pump over 24 weeks. The treatment is given to people aged 16 to 50 with DS to assess effects on cognition and smell. Participants will undergo cognitive and behavioral assessments, blood tests for metabolic measures, and brain imaging. Researchers will measure changes in cognition from baseline to the end of treatment at week 24. Secondary tests include memory, language, and quality of life evaluations. Safety and health markers will also be monitored. The study includes random assignment to treatment or placebo and uses triple masking to ensure unbiased results.
CONDITIONS
Brief Title
GnRH Therapy on Cognition in Down Syndrome
Who Can Participate
Age: 16Years - 50Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of trisomy 21
- Ability to communicate verbally and follow study procedures
- Consent to use non-hormonal contraception throughout the study (specific methods required for women and men)
You will not qualify if you...
- Acute illness or hospitalization
- Chronic alcohol or drug abuse, anabolic steroid abuse, or use of psychotropic drugs as reported by caregivers
- Use of medications that affect hormones such as spironolactone, ketoconazole, anticoagulants, corticosteroids, ACTH hormone, antidepressants, antipsychotics, or anticonvulsants
- Known pituitary adenoma or other hormone-dependent tumors
- Participation in another clinical study
- Intention to become a parent during the study
- Females with ovarian cysts, non-hypothalamic anovulation, pregnancy, or breastfeeding
- Males with hematocrit over 54%
- Contraindications to MRI such as pacemaker or metal clips
- Participant or legal representative does not want to be informed of incidental findings
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 24 weeks
Participants receive pulsatile GnRH or placebo therapy administered by a subcutaneous pump to evaluate effects on cognition and other health measures.
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
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Research Team
P
Pulse-UP study
T
Tommaso Todisco, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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