BioMIND (Biomarkers for the Molecular Identification of Neurodegenerative Dementia) - Improving Access to Alzheimer's Disease Diagnostics: A Pragmatic System Level Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Time from Referral to Diagnosis with biomarkers
研究概览
简要总结
The BioMIND (Biomarkers for the Molecular Identification of Neurodegenerative Dementia) pilot study was launched at Parkwood Hospital in response to national calls for implementation of biomarker diagnostics in Canada. It evaluated the feasibility, impact, and equity of introducing blood biomarker testing, lumbar punctures, and amyloid Positron Emission Tomography (PET) scans into clinical pathways. The study found that the Biomarker-First pathway significantly reduced the time from referral to diagnosis (195 versus 533 days - a difference of 318 days), demonstrating the value in implementing clinical biomarkers to bypass bottlenecks created by the need for specialist assessments. Building on these findings, the next phase of BioMIND is aimed at reducing wait times for biomarker diagnostics for patients with symptoms suggestive of mild cognitive impairment (MCI) and early AD.
The aim is to understand these wait times to biomarker testing using a nurse-led triage support tool. Group A participants will be pre-screened using this tool that includes the eligibility criteria for the study. This will help understand, out of everybody coming to the Aging Brain and Memory Clinic (ABMC) who've indicated interest in research, which people would be eligible to receive AD biomarkers if they were clinically available. Comparison of Group A's time to diagnosis with Group B and C's, who would have had a specialist appointment within 18 months and were referred to research to receive AD biomarkers through this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual with MCI or early dementia (if not yet diagnosed, individuals with amnestic changes in memory as shown on MoCA)
- •MoCA score must be 10 to 28 inclusive
- •Age 50 to 90 years inclusive
排除标准
- •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).
- •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.
- •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
- •Pregnant women and breastfeeding mothers.
- •Individuals who are unable to complete assessments in the English language.
- •Individuals who cannot provide consent
研究组 & 干预措施
Group A
Biomarker First - Participants who have not yet completed assessment at Parkwood Institute in the Aging Brain and Memory Clinic for memory concerns
Group B
Biomarker Second from Aging Brain and Memory Clinic - Participants who have completed assessment at Parkwood Institute in the Aging Brain and Memory Clinic for memory concerns and have been referred after their specialist visit to the study
Group C
Biomarker Second from Regional Partners - Participants who have completed assessment for memory concerns from a clinician outside of the Aging Brain and Memory Concern and have referred directly to the study
结局指标
主要结局
Time from Referral to Diagnosis with biomarkers
时间窗: Group A - under 250 days. Group B and C - under 365 days
Will be measured by number of days between referral and disclosure of results
次要结局
- Develop a targeted decision support tool for the early identification of patients with MCI or early AD in Group A with diagnostic accuracy of 80% or higher(throughout study until completion, approximately 2 years)
- evaluate the impact of biomarker results on participants(survey given before results and within 1 month after results are received)
- understand the regional impact of biomarker testing(at time of referral)
研究者
Jaspreet Bhangu
Geriatrician
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's