Comprehensive Assessment of Neurodegeneration and Dementia
NCT03402919
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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)
- 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
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| Descriptive Information | |||||||||||||
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| Brief Title | Comprehensive Assessment of Neurodegeneration and Dementia | ||||||||||||
| Official Title | The Comprehensive Assessment of Neurodegeneration and Dementia Study | ||||||||||||
| Brief Summary | 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 | 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. | ||||||||||||
| Study Type | Observational | ||||||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||||||||||
| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Retention: Samples With DNA Description: Blood, Saliva, Urine, Feces, Cerebrospinal Fluid | ||||||||||||
| Sampling Method | Non-Probability Sample | ||||||||||||
| Study Population | 2300 English and/or French-speaking participants recruited from across Canada in the following groups:
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| Condition | Dementia | ||||||||||||
| Intervention | Not Provided | ||||||||||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||||||
| Recruitment Information | |||||||||||||
| Recruitment Status | Recruiting | ||||||||||||
| Estimated Enrollment | 2300 | ||||||||||||
| Original Estimated Enrollment | Same as current | ||||||||||||
| Estimated Study Completion Date | September 2023 | ||||||||||||
| Estimated Primary Completion Date | September 2023 (Final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 50 Years to 90 Years (Adult, Older Adult) | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts |
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| Listed Location Countries | Canada | ||||||||||||
| Removed Location Countries | |||||||||||||
| Administrative Information | |||||||||||||
| NCT Number | NCT03402919 | ||||||||||||
| Other Study ID Numbers | CCNA 2015 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | McGill University | ||||||||||||
| Study Sponsor | McGill University | ||||||||||||
| Collaborators |
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| Investigators |
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| PRS Account | McGill University | ||||||||||||
| Verification Date | September 2019 | ||||||||||||