Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Parkwood Hospital, London, Ontario | OTHER |
Not provided
Not provided
Not provided
Not provided
This is a prospective, observational, case control study in a real-world cohort of patients referred by a primary care physician to a tertiary memory clinic for cognitive concerns. This study's main objective is to determine the effect of using standardized criteria (based on eligibility for disease modifying treatment (DMT)) to triage patients towards biological staging of disease with biomarker testing.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Participants who have not yet completed assessment at Parkwood Institute for memory concerns | ||
| Group B | Participants who have completed assessment at Parkwood Institute for memory concerns. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Determine the feasibility of integrating a CSF biomarker into diagnostic decision making for AD. | Analysis of resources needed to conduct testing including personnel required, time requirements, space, and resources/equipment | through study completion, approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the clinical utility of CSF and PET biomarkers in the diagnostic algorithm. | Measured by investigator pre and post biomarker questionnaire indicating clinical suspicion, confidence of clinical suspicion, tests to be ordered, and management plan. | through study completion, approximately one year |
| Evaluate the impact of biomarker results on participants |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the correlation between the plasma biomarker results and CSF results and amyloid PET results | Measured by the percent agreement between plasma biomarker and CSF results and amyloid PET results | through study completion, approximately one year |
Inclusion Criteria:
Exclusion Criteria:
1) Participants who fulfill diagnostic criteria for MCI or dementia/mild or major neurocognitive disorder suspected to be due to any etiology other than AD (eg, MCI/dementia due to frontotemporal lobar degeneration, diffuse Lewy body disease, Parkinson's disease, cerebrovascular disease, normal pressure hydrocephalus, head injury, drug or alcohol abuse/dependence, anoxic brain injury, etc).
2) Presence of any neurological, psychiatric, or medical conditions associated with a long-term risk of significant cognitive impairment or dementia including, but not limited to, pre-manifest Huntington's disease, multiple sclerosis, Parkinson's disease, Down's syndrome, active alcohol/drug abuse or major psychiatric disorders including, but not limited to, schizophrenia, schizoaffective disorder, or bipolar affective disorder or current episode of major depressive disorder.
3) Current or history within the past 2 years of psychiatric diagnosis or symptoms (eg, hallucinations, major depression, or delusions) that, in the opinion of the investigator, could interfere with study procedures 4) History of epilepsy, fits, or unexplained blackouts other than vasovagal syncope within 10 years before screening.
5) Malignant neoplasms within 3 years (except for basal cell or squamous cell carcinoma in situ of the skin) 6) Women of child bearing potential and breastfeeding mothers 7) Individuals who require sedation to complete PET scan. 8) Individuals who are unable to complete assessments in the English language. 9) Individuals who cannot provide consent
Not provided
Not provided
Up to 100 participants will be included from referrals to the Aging Brain and Memory Clinic or Cognitive Neurology. Study investigators will use the CSF and PET scan results to complete the respective surveys. This is a convenience sample so there is not a statistical difference in the number of samples selected as part of this study.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkwood Institute | London | Ontario | N6C0A7 | Canada |
Individual Participant Data will only be available to local site. All study results and conclusions from the study will be shared
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Serum and plasma will be retained for future research related to biomarkers in Alzheimer's Disease
Determined by Participant Pre and Post Biomarker Questionnaire |
| through study completion, approximately one year |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |