GnRH Therapy on Cognition in Down Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2024
• Main ID: NCT04390646
• Date of registration: 05/05/2020
• Prospective Registration: Yes
• Primary sponsor: Nelly Pitteloud
• Public title: GnRH Therapy on Cognition in Down Syndrome
• Scientific title: Effect of Pulsatile GnRH Therapy on Cognition in Down Syndrome: Randomized Placebo Control Study
• Date of first enrolment: August 27, 2020
• Target sample size: 56
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04390646
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

Switzerland

Contacts

• Name: Pulse-UP Study

• Name: Pulse-UP study

• Name: Nelly Pitteloud, MD
• Affiliation: Endocrinology, Metabolism, Diabetology (CHUV)

Key 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



Age minimum: 16 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Olfaction Disorders

Cognitive Decline

Alzheimer Disease, Early Onset

Down Syndrome

Intervention(s)

Drug: GnRH, gonadorelin acetate

Drug: 0.9% NaCl

Primary Outcome(s)

Cognition [Time Frame: Baseline to end of treatment (Week 24)]

Secondary Outcome(s)

Corsi block tapping task [Time Frame: baseline to end of treatment (Week 24)]

Health-related quality of life SF-12 [Time Frame: baseline to end of treatment (Week 24)]

Dimensional change card sorting task (DCCS) [Time Frame: baseline to end of treatment (Week 24)]

High density lipoprotein (HDL)-cholesterol [Time Frame: baseline to end of treatment (Week 24)]

Insulinemia [Time Frame: baseline to end of treatment (Week 24)]

Total cholesterol [Time Frame: baseline to end of treatment (Week 24)]

Low density lipoprotein (LDL)-cholesterol [Time Frame: baseline to end of treatment (Week 24)]

Triglycerides [Time Frame: baseline to end of treatment (Week 24)]

Adaptive behavior (Vineland II) - caregiver questionnaire [Time Frame: baseline to end of treatment (Week 24)]

Litmus non-word-repetition test [Time Frame: baseline to end of treatment (Week 24)]

Paired Associated Learning (PAL, part of the CANTAB battery) [Time Frame: baseline to end of treatment (Week 24)]

Token test [Time Frame: baseline to end of treatment (Week 24)]

Glycemia [Time Frame: baseline to end of treatment (Week 24)]

Secondary ID(s)

2020-00270

700779

Pulse-UP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors