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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06168955
Other study ID # 2023-A01502-43
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2024
Est. completion date December 2025

Study information

Verified date January 2024
Source Central Hospital, Nancy, France
Contact Mathilde Renaud
Phone 0380425485
Email cppest1@chlcdijon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Alzheimer's disease (AD) is the leading cause of dementia in France. It is a multifactorial pathology, combining genetic and environmental risk factors. Homocysteine, a sulfur-containing amino acid belonging to the methionine-monocarbon cycle, has frequently been found at high levels in neurodegenerative diseases, and in AD in particular. It has been shown on human brain sections that the interaction of homocysteine with tau and MAP1, two key AD proteins, was significantly higher in AD patients than in controls, and corresponded to an N-homocysteinylation type interaction. This is a prospective study, the main objective of which is to compare MAP1 N-homocysteinylation levels in fibroblasts from individuals with AD versus disease-free cell lines.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - age > 18 years - Age of onset of AD < 75 years - Person with AD with positive CSF biomarkers - Person who has previously benefited from an analysis of AD genetic characteristics (APP, PSEN1, PSEN2, TREM2, ABCA7, SORL1 genes and ApoE status) and an analysis of monocarbon metabolism genes in the case of biochemical abnormalities by clinical exome, targeted panel or complete exome, and for whom the data set is already available. Exclusion Criteria: - Pregnant, parturient or breast-feeding women - Minor (not emancipated) - Person of legal age (subject to a legal protection measure) - Adult unable to give consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
skin biopsy
skin biopsy for cell culture and N-homocysteinylation study

Locations

Country Name City State
France Centre Hospitalier Régional Universitaire de Nancy Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary MAP1 homocysteinylation level Baseline
Secondary Homocysteinylation level of tau protein baseline
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