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

February 7, 2023 updated by: Institut Jerome Lejeune

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

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.

Study Overview

Status

Recruiting

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75015
        • Recruiting
        • Institut Jérôme Lejeune

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Down syndrome patients
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age of onset of Alzheimer's disease
Time Frame: 2 years
age (year)
2 years
Gender that could influence the age of onset of the disease as determined by medical record review
Time Frame: 2 years
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
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
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
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
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
2 years
Head trauma that could influence the age of onset of the disease as determined by medical record review
Time Frame: 2 years
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of neuropsychological evolution using Katz Index of Independence in Activities of Daily Living (Katz ADL) score
Time Frame: 2 years
Questionnaire about Activities of Daily Living such as bathing, toileting, continence, dressing, transferring and feeding Scoring : Independence: 1 point - Partial dependence 0.5 point - Full dependence: 0 point
2 years
Evaluation of neuropsychological evolution using Lawton-Brody Instrumental Activities of Daily Living scale ( IADL)
Time Frame: 2 years
Questionnaire about strumental Activities of Daily Living such as ability to use telephone, responsibility for taking medication, travels independently on public transportation, ability to handle finances Scoring : 0 or 1
2 years
Evaluation of neuropsychological evolution using Dementia Screening Questionnaire for Individuals with Intellectual Disabilities (DSQIID) score
Time Frame: 2 years
Dementia Screening for Individuals with Intellectual Disabilities Questionnary is a autonomy and psychobeahavioral questionnaire to gather information from carers of people with Down's syndrome about the symptoms of dementia
2 years
Evaluation of neuropsychological evolution using Cambridge Examination for Mental Disorders of Older People with Down's Syndrome and Others with Intellectual Disabilities score
Time Frame: 2 years
Camdex-Ds. Based on an informant interview to aid the diagnosis of dementia in people with DS according to the DSM-IV et ICD criteria for dementia.
2 years
Evaluation of neuropsychological evolution using Cambridge Cognition Examination score
Time Frame: 2 years
It is part of the CAMDEX-DS. Section 2 involves the direct assessment of patient. It contains seven different subscales and has 46 items. it gives a total score of 108. Decline between assessment at Time 1 and assessment at time 2 in association with CAMDEX confirm or evoque the AD diagnosis.
2 years
Evaluation of neuropsychological evolution using Cued Recall test score
Time Frame: 2 years
It is a memory task. It consists in 12 items accompanied by a unique category cue, presented four a time in three trials. It generates two measures respectively for learning phase and delayed recall: a free recall score/12 and a total score/36 (FRS plus items recalled with cue) for the learnig phase. A free recall (FRS/12) and a total score (FRS plus items recalled with cue /12) for the delayed recall. Number of intrusions will be also recorded.
2 years
Evaluation of neuropsychological evolution using Cancellation task
Time Frame: 2 years
Measure of task accuracy (total number of correct responses, range score 0-16) and total time performance (in seconds) were included in the analyses.
2 years
Evaluation of neuropsychological evolution using Leiter III assessment score
Time Frame: 2 years
It is a nonverbal measure of intelligence & cognitive abilities. It includes four subtests whose raw scores are converted to normalised scaled scores (mean [M] = 10, standard deviation [SD] = 3). It gives an IQ standard score (M = 100; SD = 15).
2 years
Identification of prodromal Alzheimer's disease markers using brain imaging
Time Frame: 2 years
Whole brain volumetry calculation, hippocampus volume calculation, white matter lesions volumetry calculation
2 years
Identification of prodromal Alzheimer's disease markers using dosage (pg/mL) of biomarkers in cerebrospinal fluid
Time Frame: 2 years
1-40 beta-amyloid, 1-42 beta-amyloid, tau, phosphorylated tau
2 years
Number of adverse event and serious adverse events related to trial procedures
Time Frame: 2 years
Adverse events graded 3-4-5 according to CTCAE v5.0
2 years
Evaluation of survival assessed by vital status
Time Frame: 2 years
Date and cause of death
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 26, 2019

Primary Completion (ANTICIPATED)

March 31, 2023

Study Completion (ANTICIPATED)

March 31, 2023

Study Registration Dates

First Submitted

February 4, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (ACTUAL)

April 3, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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