Biomarkers in a Candian Memory Clinic

Официальное название

Biomarkers as Part of Diagnostic Workup for Alzheimer's Disease: A Feasibility Study in a Canadian Memory Clinic

Обзор

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.

Первичные конечные точки

• Determine the feasibility of integrating a CSF biomarker into diagnostic decision making for AD. [Срок оценки: through study completion, approximately 1 year]

Вторичные конечные точки (2)

• Evaluate the clinical utility of CSF and PET biomarkers in the diagnostic algorithm. [Срок оценки: through study completion, approximately one year]
• Evaluate the impact of biomarker results on participants [Срок оценки: through study completion, approximately one year]

Критерии участия

Критерии включения

• Individual with MCI (if not yet diagnosed, individuals with amnestic changes in memory as shown on MoCA)
• MoCA score must be 18 to 28 inclusive
• Age 55 to 80 years inclusive
• Has a study partner that is willing to participate as a source of information and has approximately weekly contact with the subject (contact can be in-person, via telephone or electronic communication). The study partner must have sufficient contact such that the investigator feels the study partner can provide meaningful information about the subject's daily function.
• Group A - must have a clinical memory assessment appointment scheduled at Parkwood Institute within 18 months of baseline
• Group B - must have had a clinical memory assessment appointment at Parkwood Institute within 18 months of baseline

Критерии исключения

• 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

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 1 центр

• Parkwood Institute — London

Идентификаторы

NCT: NCT06843109 · BioMIND

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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