Comprehensive Assessment of Neurodegeneration and Dementia (COMPASS-ND)

McGill University

Status: Enrolling

Conditions: Mixed Dementia; Lewy Body Disease(LBD); Mild Cognitive Impairment (MCI); Cognitively Unimpaired; Subjective Cognitive Impairment; Subjective Cognitive Decline (SCD); Frontotemporal Dementia (FTD); Alzheimer Disease (AD); Parkinson's Disease (PD); Dementia

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03402919

CCNA 2015

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,573 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: Accepts Healthy Volunteers

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)
• 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

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 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

Trial design

1,573 participants in 8 patient groups

Normal healthy elderly

Description:

participants with no subjective or objective cognitive deficits or decline.

Subjective Cognitive Decline

Description:

Participants with a complaint of subjective cognitive impairment, but no objective evidence of such.

Mild Cognitive Impairment (MCI)

Description:

Participants with objective evidence of cognitive impairment, but it does not impact on daily function.

Vascular MCI

Description:

Participants meeting criteria of MCI who also show signs of cerebrovascular disease on imaging but have no history of stroke.

Alzheimer's Disease

Description:

Participants with dementia of the Alzheimer's type according to the National Institute of Aging-Alzheimer's Association criteria

Dementia of Mixed Etiology

Description:

Participants with dementia and evidence of more than one etiology.

Lewy Body/Parkinson's spectrum

Description:

Participants with Parkinson's disease who show mild or moderate cognitive impairment and/or dementia.

Frontotemporal dementia (FTD) spectrum

Description:

Participants with behavioral variant FTD, primary progressive aphasia, progressive supranuclear palsy, or corticobasal syndrome