Comprehensive Assessment of Neurodegeneration and Dementia

Study Overview
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Brief Summary
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This is a 5-year observational study recruiting sixteen hundred and fifty individuals between the ages of 50 and 90 with different types of dementia as well as a comparison group of six hundred and fifty aged matched individuals without cognitive deficits. Participants will be recruited at sites across Canada and will undergo assessments and provide biological samples at baseline and two years after baseline.

Detailed Description
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This is a 5-year observational study. Sixteen-hundred and fifty (1650) subjects, between the ages of 50 and 90,years old, 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 650 healthy elderly subjects without cognitive complaints or deficits, will be enrolled into this study from up to 30 centres across Canada. All subjects involved in the study will undergo 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 will be collected, stored, and analyzed. Basic follow-up determining if there has been any change in their diagnosis will be carried out annually and longitudinal re-evaluation will be carried out after two years.

Official Title
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The Comprehensive Assessment of Neurodegeneration and Dementia Study

Conditions
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Dementia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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/Lewy Body Dementia 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 MoCA < 13 Unable to undergo MRI scan due to medical contraindications or inability to tolerate the procedure

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal healthy elderly<br>participants with no subjective or objective cognitive deficits or decline. | |
| Subjective Cognitive Decline<br>Participants with a complaint of subjective cognitive impairment, but no objective evidence of such. | |
| Mild Cognitive Impairment (MCI)<br>Participants with objective evidence of cognitive impairment, but it does not impact on daily function. | |
| Vascular MCI<br>Participants meeting criteria of MCI who also show signs of cerebrovascular disease on imaging but have no history of stroke. | |
| Alzheimer's Disease<br>Participants with dementia of the Alzheimer's type according to the National Institute of Aging-Alzheimer's Association criteria | |
| Dementia of Mixed Etiology<br>Participants with dementia and evidence of more than one etiology. | |
| Lewy Body/Parkinson's spectrum<br>Participants with Parkinson's disease who show mild or moderate cognitive impairment and/or dementia. | |
| Frontotemporal dementia (FTD) spectrum<br>Participants with behavioral variant FTD, primary progressive aphasia, progressive supranuclear palsy, or corticobasal syndrome | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment (MoCA) score | 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. | 2 years |