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Normal Cognition (NC) with at least 1 vascular risk factor for Dementia (MarkVCID Trial)

N/A

Recruiting

Led By Steven M. Greenberg, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the cognitive battery is implemented, and global cognition calculated, at baseline and years 1, 2 and 3 post-baseline.

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Dementia
Cognitive Impairment

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the cognitive battery is implemented, and global cognition calculated, at baseline and years 1, 2 and 3 post-baseline.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the cognitive battery is implemented, and global cognition calculated, at baseline and years 1, 2 and 3 post-baseline.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the cognitive battery is implemented, and global cognition calculated, at baseline and years 1, 2 and 3 post-baseline. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

SVD progression as measured by decline in global cognition

Secondary study objectives

SVD progression as measured by decline in executive function

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Subjective Cognitive Decline (SCD)Experimental Treatment1 Intervention

Subjective cognitive decline is defined as: 1. Cognitive concerns based on a Short eCog-12 score ≥ 3 (based on administration to participant), AND 2. Normal cognition (neuropsychological testing within normal range).

Group II: Normal Cognition (NC) with at least 1 vascular risk factorExperimental Treatment1 Intervention

NC is defined as: 1. No diagnosis of SCD, MCI, or dementia; AND 2. CDR: Sum of Boxes = 0 AND neuropsychological testing in normal range. Participants must have at least 1 of the following criteria prior to enrollment: Diabetes (at least 1): * Fasting (8-hour) blood sugar ≥126 mg/dL * Random or Post-prandial blood sugar ≥200 mg/dL * HbA1C ≥6.5% * Treatment with anti-diabetic medicine Hypertension plus (at least 2): * Use of anti-hypertensive medications for lowering blood pressure for ≥10 years * Current use of 2 or more anti-hypertensive meds for lowering blood pressure * Blood pressure in a research or clinical setting in the last 2 years with SBP ≥140 or DBP ≥90 * Second blood pressure reading in a research or clinical setting in the last 2 years (different date) with SBP ≥140 or DBP ≥90 * Evidence of likely HTN end organ damage MRI factors (at least 1): * Peri-Ventricular Fazekas Extent Grade or Deep Fazekas Extent Grade ≥2 * ≥1 microbleeds * ≥1 lacunar infarcts

Group III: Mild DementiaExperimental Treatment1 Intervention

Mild dementia is defined as: 1. The subject has cognitive or behavioral (neuropsychiatric) symptoms that meet all of the following criteria: 1. Interfere with ability to function as before at work or at usual activities? 2. Represent a decline from previous levels of functioning? 3. Are not explained by delirium or major psychiatric disorder? AND 2. Impairment in one\* or more of the following domains. 1. Impaired ability to acquire and remember new information. 2. Impaired reasoning and handling of complex tasks, poor judgment. 3. Impaired visuospatial abilities. 4. Impaired language functions. 5. Changes in personality, behavior, or comportment \* In the event of single-domain impairment (e.g., language in PPA, behavior in bvFTD, posterior cortical atrophy), the subject must not fulfill criteria for MCI. AND 3. CDR: Global Score = 0.5 or 1

Group IV: Mild Cognitive Impairment (MCI)Experimental Treatment1 Intervention

Mild cognitive impairment is defined as: 1. There is a cognitive concern, i.e., the subject, the co-participant, or a clinician is concerned about a change in cognition compared to the subject's previous level. 2. There is impairment in one or more cognitive domains (memory, language, executive function, attention, and visuospatial skills) that is greater than would be expected for the patient's age and educational background. 3. There is largely preserved independence in functional abilities (no change from prior level of functioning or requires only extra effort and minimal aids or assistance). 4. There is no evidence of dementia (cognitive changes are mild and there is no evidence of a significant impairment in social or occupational functioning).

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