Status:
COMPLETED
Elucidating Age-related Comorbidity Patterns in Down Syndrome (DS)
Lead Sponsor:
King's College London
Collaborating Sponsors:
Fondation Jérôme Lejeune
Parc de Salut Mar
Conditions:
Down Syndrome
Eligibility:
All Genders
12-45 years
Brief Summary
This study is a non-drug, multicenter, prospective cohort study. It will be conducted in 300 volunteers from 12 to 45 years of age (inclusive) with a diagnosis of Down syndrome from 3 countries (Franc...
Detailed Description
The study will be conducted in n= 300 volunteers with DS from 3 countries (France, Spain, UK); equal numbers in 3 age groups (12 - 18 years; 19 - 34 years; 35 - 45 years). The total number of voluntee...
Eligibility Criteria
Inclusion
- Males and females aged 12 to 45 years
- With established genetic diagnosis of Down syndrome (full trisomy 21; based on karyotype results - not exclusion if not available but will need to confirm karyotype if not done previously)
- Availability of parent/caregiver to accompany the subject to clinical visits and to be willing to give written informed consent, when necessary
Exclusion
- Confirmed mosaic trisomy 21, partial trisomy 21, or translocation
- Comorbid conditions - Participation is allowed as long as the condition(s) are considered stable and it do not interfere with the participation of the study
- Subjects with evidence of dementia or meeting clinical diagnoses for dementia
- Participation in a medication treatment trial in the last 3 months prior to the study
Key Trial Info
Start Date :
June 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT05310552
Start Date
June 10 2021
End Date
June 30 2025
Last Update
July 9 2025
Active Locations (3)
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1
Institute Jérôme Lejeune
Paris, France, 75015
2
Institut Hospital del Mar d'Investigacions Mèdiques
Barcelona, Spain, 08003
3
King's College London
London, United Kingdom, SE5 8AB