NCT03901261

Cohort Study of Adult Patients With Down Syndrome at Risk of Developing Alzheimer's Disease (TriAL21)

Cohort Study of Adult Patients With Down Syndrome at Risk of Developing Alzheimer's Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Institut Jerome Lejeune · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

TriAL21 study is an interventional, open, one arm, prospective, national and single center study. A total of 200 patients with Down syndrome, aged 35 years and over, without diagnosis of Alzheimer's disease will be enrolled into the study. Participating centre is Institut Jérôme Lejeune; outpatient's clinic dedicated to treating patients with cognitive deficiencies of genetic origin including patients with Down syndrome.

Detailed description

The aim of the study is to describe and follow a cohort of patients with Down syndrome without diagnosis of Alzheimer's disease at inclusion, in order to identify factors influencing the age of onset of the disease. The total study duration will be approximately 4 years. * Inclusion period : 2 years * Follow-up period per patient : 2 years Patients will be then followed during 10 years for routine medical follow-up. In case of Alzheimer's disease onset during this period, all data regarding diagnosis of AD will be collected for the study. Data about dementia evolution and mortality in case of AD diagnosis during the study will also be collected during this follow-up period.

Conditions

• Down Syndrome
• Alzheimer Disease

Interventions

Type	Name	Description
PROCEDURE	Neuro-imaging, Lumbar puncture	Optional Lumbar Puncture will be performed at inclusion visit Optional Neuro-Imaging (MRI (Magnetic Resonance Imaging) will be performed within 3 months after inclusion visit

Timeline

• Start date: 2019-04-26
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2019-04-03
• Last updated: 2023-02-08

Locations

1 site across 1 country: France