Biomarkers for Dementia

(MarkVCID Trial)

Not currently recruiting at 17 trial locations

Overseen By Carissa Tuozzo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: Anti-diabetics, Anti-hypertensives

Must not be taking: Anti-amyloid immunotherapy

Disqualifiers: Parkinson's, Schizophrenia, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify biomarkers (biological indicators) that signal brain changes related to thinking and memory issues, such as Alzheimer's disease. The focus is on conditions affecting blood vessels in the brain, which can lead to cognitive decline and dementia. Researchers will measure participants' biomarkers to understand how these changes might predict or relate to memory loss. Suitable candidates have a history of diabetes, high blood pressure, or specific MRI findings and are experiencing memory or cognitive changes.

As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage findings.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover how vascular factors contribute to cognitive impairment and dementia. Unlike current treatments that primarily focus on managing symptoms of cognitive decline, this study zeroes in on identifying biomarkers that could help predict and understand the progression of conditions like mild cognitive impairment and dementia. By examining the link between vascular health and cognitive function, this research could pave the way for preventative strategies and more targeted treatments in the future.

Who Is on the Research Team?

Steven M. Greenberg, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

I can safely undergo an MRI scan.

My blood sugar level has been 200 mg/dL or higher.

I am between 60 and 90 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline cognitive assessments and biomarker measurements are conducted

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for changes in cognitive function and biomarker levels

3 years

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

Group I: Subjective Cognitive Decline (SCD) Experimental Treatment 1 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 factor Experimental Treatment 1 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 Dementia Experimental Treatment 1 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 Treatment 1 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).

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Olive View-UCLA Education & Research Institute

Collaborator

Trials

34

Recruited

880,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+