Cohort Study of Adult Patients With Down Syndrome at Risk of Developing Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Gender that could influence the age of onset of the disease as determined by medical record review
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Gender that could influence the age of onset of the disease as determined by medical record review
时间窗: 2 years
Cardio-vascular risk factors that could influence the age of onset of the disease as determined by medical record review
时间窗: 2 years
Age of menopause that could influence the age of onset of the disease as determined by medical record review
时间窗: 2 years
Head trauma that could influence the age of onset of the disease as determined by medical record review
时间窗: 2 years
Level of intellectual diasability that could influence the age of onset of the disease as determined by medical record review
时间窗: 2 years
Family history of Alzheimer's disease that could influence the age of onset of the disease as determined by medical record review
时间窗: 2 years
Age of onset of Alzheimer's disease
时间窗: 2 years
age (year)
Down syndrome comorbidies that could influence the age of onset of the disease as determined by medical record review
时间窗: 2 years
Genetic's factor other than APP that could influence the age of onset of the disease as determined by medical record review
时间窗: 2 years
次要结局
- Evaluation of neuropsychological evolution using Lawton-Brody Instrumental Activities of Daily Living scale ( IADL)(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(2 years)
- Evaluation of neuropsychological evolution using Leiter III assessment score(2 years)
- Identification of prodromal Alzheimer's disease markers using brain imaging(2 years)
- Evaluation of neuropsychological evolution using Cambridge Cognition Examination score(2 years)
- Identification of prodromal Alzheimer's disease markers using dosage (pg/mL) of biomarkers in cerebrospinal fluid(2 years)
- Evaluation of survival assessed by vital status(2 years)
- Evaluation of neuropsychological evolution using Katz Index of Independence in Activities of Daily Living (Katz ADL) score(2 years)
- Evaluation of neuropsychological evolution using Dementia Screening Questionnaire for Individuals with Intellectual Disabilities (DSQIID) score(2 years)
- Evaluation of neuropsychological evolution using Cued Recall test score(2 years)
- Evaluation of neuropsychological evolution using Cancellation task(2 years)
- Number of adverse event and serious adverse events related to trial procedures(2 years)