Clinical trial NCT03901261: Cohort Study of Adult Patients With Down Syndrome at Risk of Developing Alzheimer's Disease (TriAL21)
Official title: Cohort Study of Adult Patients With Down Syndrome at Risk of Developing Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Down Syndrome
Alzheimer Disease
Keywords: Down Syndrome
Alzheimer Disease
Marker
Neuropsychological
Prodromal
Risk factors
Lead sponsor: Institut Jerome Lejeune
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 200
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional prospective monocentric, national open study with single arm
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Age of onset of Alzheimer's disease
timeFrame: 2 years
measure: Gender that could influence the age of onset of the disease as determined by medical record review
timeFrame: 2 years
measure: Level of intellectual diasability that could influence the age of onset of the disease as determined by medical record review
timeFrame: 2 years
measure: Family history of Alzheimer's disease that could influence the age of onset of the disease as determined by medical record review
timeFrame: 2 years
measure: Cardio-vascular risk factors that could influence the age of onset of the disease as determined by medical record review
timeFrame: 2 years
measure: Down syndrome comorbidies that could influence the age of onset of the disease as determined by medical record review
timeFrame: 2 years
measure: Genetic's factor other than APP that could influence the age of onset of the disease as determined by medical record review
timeFrame: 2 years
measure: Head trauma that could influence the age of onset of the disease as determined by medical record review
timeFrame: 2 years
measure: Age of menopause that could influence the age of onset of the disease as determined by medical record review
timeFrame: 2 years
Secondary outcomes:
measure: Evaluation of neuropsychological evolution using Katz Index of Independence in Activities of Daily Living (Katz ADL) score
timeFrame: 2 years
measure: Evaluation of neuropsychological evolution using Lawton-Brody Instrumental Activities of Daily Living scale ( IADL)
timeFrame: 2 years
measure: Evaluation of neuropsychological evolution using Dementia Screening Questionnaire for Individuals with Intellectual Disabilities (DSQIID) score
timeFrame: 2 years
measure: Evaluation of neuropsychological evolution using Cambridge Examination for Mental Disorders of Older People with Down's Syndrome and Others with Intellectual Disabilities score
timeFrame: 2 years
measure: Evaluation of neuropsychological evolution using Cambridge Cognition Examination score
timeFrame: 2 years
measure: Evaluation of neuropsychological evolution using Cued Recall test score
timeFrame: 2 years
measure: Evaluation of neuropsychological evolution using Cancellation task
timeFrame: 2 years
measure: Evaluation of neuropsychological evolution using Leiter III assessment score
timeFrame: 2 years
measure: Identification of prodromal Alzheimer's disease markers using brain imaging
timeFrame: 2 years
measure: Identification of prodromal Alzheimer's disease markers using dosage (pg/mL) of biomarkers in cerebrospinal fluid
timeFrame: 2 years
measure: Number of adverse event and serious adverse events related to trial procedures
timeFrame: 2 years
measure: Evaluation of survival assessed by vital status
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Jérôme Lejeune
Study officials:
References:
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