Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium

Running, not enrolling

Conditions studied: Cognitive Impairment, Dementia

In brief

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.

Key facts

Study ID: NCT06284213
Run by: Massachusetts General Hospital
People needed: 1892
Starts: 2021-09-29
Expected to finish: 2027-07-01
Last updated by the study team: 2025-01-29

Who can join

Age: 60 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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