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Clinical Trials in Mexico / NCT06284213
Active, not recruiting Observational

Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium

NCT06284213 · tracked via the Priya Life Science Mexico tracker
Phase
Observational
Started
2021-09-29
Last updated
2025-01-29

Condition(s) studied

Cognitive ImpairmentDementia

Investigational drug(s) / intervention(s)

No interventions

No interventions: This is an observational study with no interventions.

Study summary

Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia (MarkVCID) is an NIH-funded consortium dedicated to finding biomarkers involved in age-related thinking and memory problems. Alzheimer's disease and other dementias leave signatures on brain scans or in the blood called biomarkers. The MarkVCID study will measure a panel of candidate biomarkers in 1800 participants and watch them closely to see what they tell us about changes in brain function and risk of memory loss.

Age-related problems in thinking and memory represent some of the greatest risks to public health in the US and globally. Diseases that affect small blood vessels in the brain have been shown to be major contributors to these changes. However, research and patient care can be held back by limited biomarkers that identify who should be treated.

The MarkVCID Consortium includes 17 US medical centers, a Coordinating Center, an External Advisory Committee, and NIH leadership. Data and biospecimens collected as part of this research study will be stored in a research database and biorepositories, so that researchers can use this information to study brain function.

Eligibility

Sex
ALL
Min age
60 Years
Max age
90 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Age ≥ 60 and ≤ 90 years * Diagnosis of normal cognition with at least one criterion for vascular risk\*, subjective cognitive decline (preliminary diagnosis based on self-report question or eCog-12), mild cognitive impairment, or mild dementia based on standard research criteria * Fluent in English or Spanish * No contraindications to MRI including CVR * No confounding neurologic, psychiatric, or medical disease \*Participants with normal cognition must meet at least one criterion (diabetes, OR hypertension plus, OR MRI factors) for vascular risk prior to enrollment: * Diabetes (at least one of the following): * Fasting (8-hour fast, usually overnight) blood sugar ≥126 mg/dL (≥7 mmol/L, or ≥1260 mg/L) * Random or Post-prandial blood sugar ≥200 mg/dL (≥11.11 mmol/L, or ≥2000 mg/L) * HbA1C ≥6.5% (or ≥47.5412 mmol/mol) * Treatment with an anti-diabetic medicine * Hypertension plus (at least two of the following): * Use of anti-hypertensive medications for lowering blood pressure for ≥ 10 years * Current use of two or more anti-hypertensive medications for lowering blood pressure * One measured blood pressure in a research or clinical setting in the last 2 years with SBP ≥140 or DBP ≥90 * A second measured blood pressure in a research or clinical setting on a different date in the last 2 years with SBP ≥140 or DBP ≥90 * Evidence of likely HTN end-organ damage (e.g., LVH, albuminuria, eGFR\<60, CHF) * MRI factors (at least one of the following): * Peri-Ventricular Fazekas Extent Grade or Deep Fazekas Extent Grade ≥ 2 * 1 or more microbleeds * 1 or more lacunar infarcts Exclusion Criteria: * Neurologic Disease: Based on the available data and investigator's impression, exclude those with confounding neurologic disease that would interfere with test performance or with biomarker analysis: * Frontotemporal lobar degeneration (FTLD) * Lewy body dementia (LBD) * Parkinson's disease * Multi system atrophy * Traumatic brain injury (TBI)-related cognitive impairment * TBI that interferes with MRI biomarker analyses (e.g., large volume traumatic lesion) * Non-small vessel strokes that interfere with test performance (e.g., post-stroke cognitive impairment or aphasia) * Non-small vessel strokes that interfere with MRI biomarker analysis (e.g., large volume strokes) * CADASIL (Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy) * Individuals known to be receiving, or planning to receive, anti-amyloid immunotherapy\* * Other neurologic conditions that interfere with test performance or biomarker analysis * Individuals prescribed anti-amyloid immunotherapy after MarkVCID enrollment should be kept in the study. * Medical and Psychiatric Conditions: Exclude those with medical and psychiatric conditions that would confound the course or interfere with test performance: * Schizophrenia or other active/severe psychotic disorders * Medical or psychiatric conditions likely to interfere with participation or retention (e.g., metastatic or malignant CNS cancer, active/severe depression or anxiety, HIV- Associated Neurocognitive Disorder) * Contraindications to MRI procedures, such as: * Claustrophobia * Cardiac pacemaker * Intracranial clips/metal implants * Contraindications to CVR: * COPD or other respiratory condition requiring oxygen therapy * Asthma or other respiratory condition requiring current use of medications such as inhalers

Primary outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
University of Southern California Los Angeles California
University of California Los Angeles Los Angeles California
University of California Davis Sacramento California
University of California San Francisco San Francisco California
Olive View - UCLA Medical Center Sylmar California
Mayo Clinic Florida Jacksonville Florida
Rush University Medical Center & Illinois Institute of Technology Chicago Illinois
University of Kentucky Lexington Kentucky
University of Maryland, Baltimore Baltimore Maryland
Johns Hopkins University Baltimore Maryland
Mayo Clinic Rochester Rochester Minnesota
University of Mississippi Medical Center Jackson Mississippi
Washington University in St. Louis St Louis Missouri
University of New Mexico Albuquerque New Mexico
University of Texas Southwestern Dallas Texas
University of Texas Health Science Center Houston Houston Texas
University of Texas Health Science Center San Antonio San Antonio Texas

More Massachusetts General Hospital trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06284213 on ClinicalTrials.gov ↗ ← All trials in Mexico