BioMIND (Biomarkers for the Molecular Identification of Neurodegenerative Dementia) - Improving Access to Alzheimer's Disease Diagnostics: A Pragmatic System Level Intervention

Обзор

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.

Первичные конечные точки

• Time from Referral to Diagnosis with biomarkers [Срок оценки: Group A - under 250 days. Group B and C - under 365 days]

Вторичные конечные точки (3)

• 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 [Срок оценки: throughout study until completion, approximately 2 years]
• evaluate the impact of biomarker results on participants [Срок оценки: survey given before results and within 1 month after results are received]
• understand the regional impact of biomarker testing [Срок оценки: at time of referral]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07422038 · BioMIND 2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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