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New treatment option for Down Syndrome
Official title GnRH Therapy on Cognition in Down Syndrome
ClinicalTrials.gov ID: NCT04390646
What this study is testing
What is GnRH, gonadorelin acetate?
GnRH, gonadorelin acetate is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for down syndrome.
Also referred to as Lutrelef.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 of death within this population.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 50
You may be able to join 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...
You likely can't join 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...
- Known pituitary adenoma and other hormone-dependent tumours
- Participation in another clinical study
- Intention to become a parent during the course of the study
See the full eligibility 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
- 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 study team makes the final eligibility decision.
Where it's taking place
- Lausanne, Canton of Vaud, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lausanne, Canton of Vaud, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.