Last updated: May 16, 2022
Sponsor: University of British Columbia
Overall Status: Active - Not Recruiting
Phase
N/A
Condition
Learning Disorders
Alzheimer's Disease
Dementia
Treatment
N/AClinical Study ID
NCT05002699
H17-01339
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participant is either a dementia specialist, or a patient of a consenting dementiaspecialist;
- Patient participant is age 40 and older;
- Patient participant has a diagnosis verified by a dementia specialist within 24 monthsof: subjective cognitive decline (Shaw et al., 2018), or mild cognitive impairment ordementia, according to DSM-IV (DSM-IV-TR, 2000) and/or National Institutes ofAging-Alzheimer's Association (Albert et al., 2011; McKhann et al., 2011) criteria;
- The etiologic cause of cognitive impairment is uncertain after a comprehensiveevaluation by a dementia specialist, including general medical and neurologicalexamination, mental status testing including standard measures of cognitiveimpairment, laboratory testing, and structural neuroimaging;
- Cognitive disorder is considered to be on the Alzheimer's continuum, including, butnot limited to, mild cognitive impairment with suspected Alzheimer's pathology thatdoes not reach the criteria for dementia;
- Dementia specialist deems that CSF Alzheimer's disease biomarkers are appropriate asper routine clinical care;
- Patient participant consents to a lumbar puncture for CSF analysis as part of clinicalcare.
Exclusion
Exclusion Criteria:
- Patient participant has normal cognition;
- Patient participant lumbar puncture requires imaging guidance;
- Knowledge of amyloid status, in the opinion of the treating dementia specialist, maycause significant psychological harm or otherwise negatively impact the patient orfamily;
- Amyloid status already known to patient or dementia specialist based on prior Aβpositron emission tomography (PET) imaging or previous CSF analysis;
- Aβ and tau CSF biomarkers ordered solely based on a family history of dementia,presence of apolipoprotein E4 genotype, or as a screening test for asymptomaticindividuals;
- Aβ and tau CSF biomarkers ordered for non-medical purposes (e.g., legal, employmentscreening, insurance coverage, patient or family member curiosity);
- Current (i.e., active) patient participation in an anti-amyloid or anti-tautherapeutic trial;
- Presence of other significant chronic brain disease in patient (e.g., malignanttumor);
- Patient had symptomatic stroke or transient ischemic attack within the previous 12months;
- Life expectancy of patient is less than 24 months based on medical co-morbidities;
- Lack of caregiver who can provide corroborative information if the patient participantlacks capacity to do so themselves.
Study Design
Total Participants: 120
Study Start date:
February 01, 2019
Estimated Completion Date:
March 31, 2023
Study Description
Connect with a study center
Northern Health
Prince George, British Columbia
CanadaSite Not Available
Providence Health Care
Vancouver, British Columbia
CanadaSite Not Available
Vancouver Coastal Health
Vancouver, British Columbia
CanadaSite Not Available
Island Health
Victoria, British Columbia
CanadaSite Not Available

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