Informations générales (source: ClinicalTrials.gov)
Cohort Study of Adult Patients With Down Syndrome at Risk of Developing Alzheimer's Disease
Interventional
N/A
Institut Jerome Lejeune (Voir sur ClinicalTrials)
avril 2019
mars 2023
08 février 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CDS DE L INSTITUT PASTEUR | Anne-Sophie REBILLAT, MD, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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.