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)
SVD progression as measured by decline in global cognition — The cognitive battery is implemented, and global cognition calculated, at Baseline and Years 1, 2 and 3 post-baseline. Global cognition scores will be calculated at each study timepoint as an average of age- and education-specific z-scores, based on tests scores from the MarkVCID2 cognitive battery (MoCA, Neuropsychological Testing Battery, Clinical Dementia Rating), which is based on Version 3 of the National Alzheimer's Coordinating Center's (NACC) Uniform Data Set (UDS) (Besser 2018).
Trial sites (17)
Facility
City
Region
Status
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.