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RecruitingPhase 2 / PHASE3

GnRH Therapy on Cognition in Down Syndrome

Effect of Pulsatile GnRH Therapy on Cognition in Down Syndrome: Randomized Placebo Control Study

Lead sponsor

Nelly Pitteloud

Asset

GnRH, gonadorelin acetate

Listed sites

1

Recruiting sites

1

Enrollment

56

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Age 16-50•MRI contraindications excluded

Primary endpoint

•Montreal Cognitive Assessment (MoCA)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Secondary ID2020-00270Swissethics
Secondary ID700779Swissmedic
NCT IDNCT04390646
Org study IDPulse-UP

Timeline

Milestones

Study first posted2020-05-15actual
Study start2020-08-27actual
Last update posted2024-02-12actual
Primary completion2028-12estimated (month precision)
Study completion2028-12estimated (month precision)

Assets

Drug assets

GnRH, gonadorelin acetate

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age16 Years
Maximum age50 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
10
Global cognition
1
Memory
1
Function / daily living
1
Caregiver / quality of life
1

Global cognition

1 endpoint
Primary/protocol endpoint

Cognition

Time frame:Baseline to end of treatment (Week 24)

Montreal Cognitive Assessment (MoCA)

descriptive

Memory

1 endpoint
Secondary/protocol endpoint

Corsi block tapping task

Time frame:baseline to end of treatment (Week 24)

change from baseline, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

Adaptive behavior (Vineland II) - caregiver questionnaire

Time frame:baseline to end of treatment (Week 24)

change from baseline, improvement

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

Health-related quality of life SF-12

Time frame:baseline to end of treatment (Week 24)

descriptive

Other (unclassified)

10 endpoints
Secondary/protocol endpoint/low confidence

Dimensional change card sorting task (DCCS)

Time frame:baseline to end of treatment (Week 24)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Paired Associated Learning (PAL, part of the CANTAB battery)

Time frame:baseline to end of treatment (Week 24)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Token test

Time frame:baseline to end of treatment (Week 24)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Litmus non-word-repetition test

Time frame:baseline to end of treatment (Week 24)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Glycemia

Time frame:baseline to end of treatment (Week 24)

concentration, descriptive

Secondary/protocol endpoint/low confidence

Insulinemia

Time frame:baseline to end of treatment (Week 24)

concentration, descriptive

Secondary/protocol endpoint/low confidence

Total cholesterol

Time frame:baseline to end of treatment (Week 24)

descriptive

Secondary/protocol endpoint/low confidence

High density lipoprotein (HDL)-cholesterol

Time frame:baseline to end of treatment (Week 24)

descriptive

Secondary/protocol endpoint/low confidence

Low density lipoprotein (LDL)-cholesterol

Time frame:baseline to end of treatment (Week 24)

descriptive

Secondary/protocol endpoint/low confidence

Triglycerides

Time frame:baseline to end of treatment (Week 24)

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.