The Comprehensive Assessment of Neurodegeneration and Dementia Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,573
- 试验地点
- 29
- 主要终点
- Montreal Cognitive Assessment (MoCA) score
研究概览
简要总结
This is a longitudinal observational study recruiting individuals between the ages of 50 and 90 with different types of dementia as well as a comparison group without cognitive deficits. Participants are/will be recruited at sites across Canada and will undergo assessments, neuroimaging, and biological sample collection.
详细描述
This is a longitudinal observational study that started in Phase I with the recruitment of 1173 participants between the ages of 50 and 90 years with Subjective Cognitive Impairment, Mild Cognitive Impairment, Mild Cognitive Impairment with subcortical vascular lesions, Alzheimer's Disease, Mixed dementia, Lewy Body Dementia, Parkinson's Disease Dementia, Parkinson's Disease with Mild Cognitive Impairment and Frontotemporal Dementia as well as healthy elderly subjects without cognitive complaints or deficits. These participants were enrolled in 30 different centres across Canada.
All subjects involved in the study underwent rigorous evaluations at baseline, including clinical assessment, neuropsychological assessment, genomics and neuroimaging. Biological samples from blood, saliva, urine, fecal matter, buccal cells and cerebrospinal fluid were collected, stored, and analyzed.
Longitudinal follow-up determining if there has been any change in their diagnosis was carried out annually and longitudinal re-evaluation was carried out at two times: Time 2 and Time 3.
In Time 3, 400 participants across the non-dementia cohorts (Cognitively Unimpaired, Subjective Cognitive Impairment, Mild Cognitive Impairment, Mild Cognitive Impairment with a Vascular Component, Parkinson's Disease with no Cognitive Impairment, Parkinson's Disease with Mild Cognitive Impairment) with up to 12 years of education will be recruited.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has subjective or objective cognitive impairment
- •Written informed consent must be obtained and documented (from the patient or, where jurisdictions allow it, from a caregiver/family member)
- •Sufficient proficiency in English or French to undertake self report and neuropsychological testing
- •Geographic accessibility to the study site
- •Must have a study partner who can participate as required in the protocol (provide corroborative information)
- •Up to 12 years of education
- •Fits into one of the following groups: Cognitively Unimpaired, Subjective Cognitive Impairment, Mild Cognitive Impairment, Vascular Mild Cognitive Impairment, Parkinson's Disease, Parkinson's Disease with Mild Cognitive Impairment
排除标准
- •The presence of other significant known chronic brain disease such as: moderate to severe chronic static leukoencephalopathy (including previous traumatic injury), multiple sclerosis, a serious developmental handicap, malignant tumors, Parkinson's disease (other than for the Parkinson's cohort), and other rarer brain illnesses
- •Ongoing alcohol or drug abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures
- •Symptomatic stroke within the previous year
- •Unable to undergo MRI scan due to medical contraindications or inability to tolerate the procedure
结局指标
主要结局
Montreal Cognitive Assessment (MoCA) score
时间窗: 2 years
change in MoCA total score. The MoCA is a test of global cognition scored out of 30 with a higher score indicating better performance. The minimum score is 0 and the maximum score is 30.
次要结局
未报告次要终点
研究者
Howard Chertkow
Principal Investigator
Baycrest