Viewing Study NCT04390646



Ignite Creation Date: 2024-05-06 @ 2:42 PM
Last Modification Date: 2024-10-26 @ 1:35 PM
Study NCT ID: NCT04390646
Status: RECRUITING
Last Update Posted: 2024-02-12
First Post: 2020-05-05

Brief Title: GnRH Therapy on Cognition in Down Syndrome
Sponsor: Nelly Pitteloud
Organization: Centre Hospitalier Universitaire Vaudois

Study Overview

Official Title: Effect of Pulsatile GnRH Therapy on Cognition in Down Syndrome Randomized Placebo Control Study
Status: RECRUITING
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Alzheimers disease AD is the most common cause of death within this population DS individuals already show AD neuropathology by the age of 30 while it becomes clinically recognized in their late forties DS subjects also exhibit olfaction defects in adulthood

To date there is no treatment available for the cognitive or olfactory defects in DS The development of an effective treatment targeting cognitive dysfunction in DS adolescentsadults would be warranted

GnRH a decapeptide secreted by hypothalamic neurons is the pilot light of reproduction in all mammals Pulsatile GnRH acts on the gonadotrophs via the GnRH receptor GNRHR in the pituitary gland to stimulate LH and FSH which themselves will act on the gonads to produce gametes and steroids However GNRHR are also expressed in cerebral cortex hippocampus amygdala habenula olfactory structures and adrenal gland suggesting that GnRH may have a role beyond reproduction

Recently GnRH has been shown to be involved in the process of ageing and lifespan control Notably in murine models GnRH acts as an anti-ageing factor independent of sex hormones While ageing is characterized by hypothalamic inflammation and diminished neurogenesis particularly in the hypothalamus and the hippocampus GnRH was able to promote adult neurogenesis

The regulation of GnRH secretion is complex and involves hormonal neuronal input and environmental factors

Prévot et al recently explored cognition within the Ts65Dn model and showed an age-dependent loss of the ability to recognize new objects Also these mice exhibit defects in olfaction Given the role of GnRH in anti-aging mice model pulsatile GnRH or continuous GnRH infusion leading to desensitization of the GNRHR were given to the Ts65Dn mice for two weeks Amazingly pulsatile but not continuous GnRH therapy was able to recover cognitive and olfaction defects
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2020-00270 OTHER Swissethics None
700779 OTHER None None