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

Institut Jerome Lejeune200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

200

Conditions

Down Syndrome Alzheimer Disease

Interventions

Neuro-imaging, Lumbar puncturePROCEDURE

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

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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.

Locations (1)

Institut Jérôme Lejeune

Paris, France

RECRUITING

Outcomes

Primary Outcomes

Age of onset of Alzheimer's disease

age (year)

Time frame: 2 years

Gender that could influence the age of onset of the disease as determined by medical record review

Time frame: 2 years

Level of intellectual diasability that could influence the age of onset of the disease as determined by medical record review

Time frame: 2 years

Family history of Alzheimer's disease that could influence the age of onset of the disease as determined by medical record review

Time frame: 2 years

Cardio-vascular risk factors that could influence the age of onset of the disease as determined by medical record review

Time frame: 2 years

Down syndrome comorbidies that could influence the age of onset of the disease as determined by medical record review

Time frame: 2 years

Genetic's factor other than APP that could influence the age of onset of the disease as determined by medical record review

Time frame: 2 years

Head trauma that could influence the age of onset of the disease as determined by medical record review

Time frame: 2 years

Age of menopause that could influence the age of onset of the disease as determined by medical record review

Time frame: 2 years

Secondary Outcomes

Evaluation of neuropsychological evolution using Katz Index of Independence in Activities of Daily Living (Katz ADL) score

Central Contacts

Anne-Sophie REBILLAT, MD, PhD

CONTACT

+33 1 56 58 63 00 annesophie.rebillat@institutlejeune.org

Data from ClinicalTrials.gov

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