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

Institut Jerome Lejeune

Status

Enrolling

Conditions

Alzheimer Disease

Down Syndrome

Treatments

Procedure: Neuro-imaging, Lumbar puncture

Study type

Interventional

Funder types

Other

Identifiers

NCT03901261

TriAL21

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female 35 years old and over ;
Clinical diagnosis of Down syndrome ;
Patient attending the geriatric outpatient clinic
Patient without diagnosis of Alzheimer's disease;
Patient covered by social welfare;
Patient himself or legal guardian/representative willing and consenting to participate to the study by giving written informed consent;
Patients must have a parent, or / and other reliable caregiver who agrees to accompany him/her to all visits, provide information about the patient as required by the protocol. The parent or caregiver must be a constant and reliable informant with sufficient contact with the patient to have detailed knowledge of the patient's adaptive functioning in order to be able to complete the assessments accurately.

Exclusion criteria

Patient presenting a contraindication to MRI in particular carrier of metal implants such as pacemakers;
Patient presenting a serious, severe or unstable pathology (left to the investigator's discretion) whose nature may interfere with the evaluation parameters;
Patient without Alzheimer's disease diagnosis but with severe dementia;
Participation in other clinical trials in the last 3 months prior to the study;
Pregnant woman.