Cognitive ImpairmentMarkVCIDNCT06284213
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
An observational study of Cognitive Impairment and Dementia, run by Massachusetts General Hospital at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Dementia
- How many people
- 1,892 participants
- Where
- 17 sitesUnited States
- Study dates
- 29 Sep 2021to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be selected from a variety of sources across the MarkVCID Consortium sites. These sources include, but are not limited to: * MarkVCID1 or other research studies * Alzheimer's Disease Research Center database * Patient registries such as Volunteer for Health * Community centers or organizations * Clinics: * Primary care * Neurology * Stroke Center * Outpatient Diabetes * Memory \& Aging
Who may be able to join
- 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:
Show all 21Show fewer
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of New Mexico
Albuquerque, New Mexico, 87131
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Johns Hopkins University
Baltimore, Maryland, 21287
Rush University Medical Center & Illinois Institute of Technology
Chicago, Illinois, 60612
University of Texas Southwestern
Dallas, Texas, 75390
University of Texas Health Science Center Houston
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Mayo Clinic Florida
Jacksonville, Florida, 32224
University of Kentucky
Lexington, Kentucky, 40536
University of Southern California
Los Angeles, California, 90033
University of California Los Angeles
Los Angeles, California, 90095
Mayo Clinic Rochester
Rochester, Minnesota, 55901
University of California Davis
Sacramento, California, 95817
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
University of California San Francisco
San Francisco, California, 94158
Washington University in St. Louis
St Louis, Missouri, 63110
Olive View - UCLA Medical Center
Sylmar, California, 91342
About this study
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.
Read the detailed description
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia (MarkVCID) is an NIH-funded multisite consortium dedicated to developing promising predictive, diagnostic, target engagement and progression candidate biomarkers of small vessel disease in VCID. MarkVCID is a collaborative consortium of nine North American research sites (consisting of 17 institutions nationwide), a Coordinating Center, External Advisory Committee, and NIH leadership.
MGH serves as the Consortium's Coordinating Center and is comprised of an administrative and data core providing participating research sites with a common support infrastructure that facilitates cross-site collaborations, oversees development of standard operating procedures and data collection methods and manages consortium-wide data.
In phase two of the MarkVCID study, research sites are charged with enrolling and following ≥200 diverse human subjects with cognitive complaints and/or early symptomatic stages of cognitive impairment and dementia potentially associated with cerebrovascular small vessel disease. Sites will share data with the Coordinating Center which will be used for validation studies of chosen consortium biomarkers. Throughout the duration of the study, sites will utilize harmonized procedures and data collection methods to engage in multi-site biomarker validation. Both Cores comply with regulations for the protection of human research subjects (including Good Clinical Practices (GCP), 21 Code of Federal Regulations (CFR)) and with the International Conference on Harmonization (ICH) Regulations E2A and E6.
- Conditions
- Cognitive Impairment, Dementia
- Being tested
- No interventions
- Keywords
- Biomarkers
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
This is an observational study with no interventions.
| Study group | Role | What they receive |
|---|---|---|
| Normal Cognition (NC) with at least 1 vascular risk factor | 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 Receives: Other: No interventions | |
| Subjective Cognitive Decline (SCD) | 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). Receives: Other: No interventions | |
| Mild Cognitive Impairment (MCI) | 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). Receives: Other: No interventions | |
| Mild Dementia | 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 Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVD progression as measured by decline in global cognition
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).
Measured: The cognitive battery is implemented, and global cognition calculated, at Baseline and Years 1, 2 and 3 post-baseline.
Secondary outcomes (1)
SVD progression as measured by decline in executive function
The measure of executive function is the Uniform Data Set (v3.0) executive function composite score (UDS3-EF) developed by Staffaroni et al (2021). The UDS3-EF is calculated from the following tests: Category Fluency - Animals; Verbal Fluency - Phonemic Tests (words beginning with F); Number Span Test (Backward); and Trail Making Tests A and B.
Measured: The cognitive battery is implemented, and executive function calculated, at Baseline and Years 1, 2 and 3 post-baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start29 Sep 2021
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,892 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Johns Hopkins University, University of New Mexico, University of Southern California, University of Kentucky, Rush University Medical Center, University of Maryland, Baltimore, University of California, San Francisco, University of California, Los Angeles, University of California, Davis, University of Texas, The University of Texas Health Science Center at San Antonio, The University of Texas Health Science Center, Houston, Mayo Clinic, University of Mississippi Medical Center, Washington University School of Medicine, Olive View-UCLA Education & Research Institute
- Responsible party
- Principal investigator, Steven M. Greenberg, MD,PhD, Massachusetts General Hospital
- Investigators
- Steven M. Greenberg, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284213
- Sponsor's protocol ID
- 5U24NS100591
- Acronym
- MarkVCID
- Status last verified
- Jan 2025
- First submitted
- 16 Feb 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: MarkVCID research openly shares both within and outside the MarkVCID Consortium to the greatest extent practical. As per the MarkVCID Consortium's Charter, MarkVCID investigators are granted broad access to MarkVCID data, samples, analytic tools, and other resources with relevant permissions in place. MarkVCID data and samples may also be shared with external collaborators in compliance with the Consortium's external data sharing policies outlined in the MarkVCID Data Use Agreement. The process for requesting data and biosamples is described below.
Publications
Besser L, Kukull W, Knopman DS, Chui H, Galasko D, Weintraub S, Jicha G, Carlsson C, Burns J, Quinn J, Sweet RA, Rascovsky K, Teylan M, Beekly D, Thomas G, Bollenbeck M, Monsell S, Mock C, Zhou XH, Thomas N, Robichaud E, Dean M, Hubbard J, Jacka M, Schwabe-Fry K, Wu J, Phelps C, Morris JC; Neuropsychology Work Group, Directors, and Clinical Core leaders of the National Institute on Aging-funded US Alzheimer's Disease Centers. Version 3 of the National Alzheimer's Coordinating Center's Uniform Data Set. Alzheimer Dis Assoc Disord. 2018 Oct-Dec;32(4):351-358. doi: 10.1097/WAD.0000000000000279.
PubMed 30376508Staffaroni AM, Asken BM, Casaletto KB, Fonseca C, You M, Rosen HJ, Boxer AL, Elahi FM, Kornak J, Mungas D, Kramer JH. Development and validation of the Uniform Data Set (v3.0) executive function composite score (UDS3-EF). Alzheimers Dement. 2021 Apr;17(4):574-583. doi: 10.1002/alz.12214. Epub 2020 Nov 20.
PubMed 33215852Kern KC, Vohra M, Thirion ML, Wang DJJ, Wilcock DM, Thompson JF, Rosenberg GA, Sagare A, Moghekar A, Lu H, Lee T, Elahi FM, Satizabal CL, Tracy R, Seshadri S, Schwab K, Helmer K, Singh H, Kivisakk P, Greenberg SM, Vossel K, Kramer JH, Maillard P, DeCarli CS, Hinman JD. White matter free water mediates the associations between placental growth factor, white matter hyperintensities, and cognitive status. Alzheimers Dement. 2025 Feb;21(2):e14408. doi: 10.1002/alz.14408. Epub 2024 Dec 18.
PubMed 39692213
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
- ClinicalTrials.gov ID
- NCT06284213
- Acronym / sponsor ID
- MarkVCID / 5U24NS100591
- Conditions
- Cognitive Impairment, Dementia
- Keywords
- Biomarkers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,892 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Duke University, Johns Hopkins University, University of New Mexico, University of Southern California, University of Kentucky, Rush University Medical Center, University of Maryland, Baltimore, University of California, San Francisco, University of California, Los Angeles, University of California, Davis, University of Texas, The University of Texas Health Science Center at San Antonio, The University of Texas Health Science Center, Houston, Mayo Clinic, University of Mississippi Medical Center, Washington University School of Medicine, Olive View-UCLA Education & Research Institute
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia (MarkVCID) is an NIH-funded multisite consortium dedicated to developing promising predictive, diagnostic, target engagement and progression candidate biomarkers of small vessel disease in VCID. MarkVCID is a collaborative consortium of nine North American research sites (consisting of 17 institutions nationwide), a Coordinating Center, External Advisory Committee, and NIH leadership.
MGH serves as the Consortium's Coordinating Center and is comprised of an administrative and data core providing participating research sites with a common support infrastructure that facilitates cross-site collaborations, oversees development of standard operating procedures and data collection methods and manages consortium-wide data.
In phase two of the MarkVCID study, research sites are charged with enrolling and following ≥200 diverse human subjects with cognitive complaints and/or early symptomatic stages of cognitive impairment and dementia potentially associated with cerebrovascular small vessel disease. Sites will share data with the Coordinating Center which will be used for validation studies of chosen consortium biomarkers. Throughout the duration of the study, sites will utilize harmonized procedures and data collection methods to engage in multi-site biomarker validation. Both Cores comply with regulations for the protection of human research subjects (including Good Clinical Practices (GCP), 21 Code of Federal Regulations (CFR)) and with the International Conference on Harmonization (ICH) Regulations E2A and E6.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Cognition (NC) with at least 1 vascular risk factor | – | Other: No interventionsNC 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 |
| Subjective Cognitive Decline (SCD) | – | Other: No interventionsSubjective 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). |
| Mild Cognitive Impairment (MCI) | – | Other: No interventionsMild 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). |
| Mild Dementia | – | Other: No interventionsMild 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 |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be selected from a variety of sources across the MarkVCID Consortium sites. These sources include, but are not limited to: * MarkVCID1 or other research studies * Alzheimer's Disease Research Center database * Patient registries such as Volunteer for Health * Community centers or organizations * Clinics: * Primary care * Neurology * Stroke Center * Outpatient Diabetes * Memory \& Aging
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (23 listed)
- 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:
- Medical and Psychiatric Conditions: Exclude those with medical and psychiatric conditions that would confound the course or interfere with test performance:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionsThis is an observational study with no interventions. | Other | Mild Cognitive Impairment (MCI), Mild Dementia, Normal Cognition (NC) with at least 1 vascular risk factor, Subjective Cognitive Decline (SCD) |
Primary outcome
SVD progression as measured by decline in global cognition
Time frame: 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).
1 secondary outcome
SVD progression as measured by decline in executive function
Time frame: The cognitive battery is implemented, and executive function calculated, at Baseline and Years 1, 2 and 3 post-baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Background: PubMed 30376508Besser L, Kukull W, Knopman DS, Chui H, Galasko D, Weintraub S, Jicha G, Carlsson C, Burns J, Quinn J, Sweet RA, Rascovsky K, Teylan M, Beekly D, Thomas G, Bollenbeck M, Monsell S, Mock C, Zhou XH, Thomas N, Robichaud E, Dean M, Hubbard J, Jacka M, Schwabe-Fry K, Wu J, Phelps C, Morris JC; Neuropsychology Work Group, Directors, and Clinical Core leaders of the National Institute on Aging-funded US Alzheimer's Disease Centers. Version 3 of the National Alzheimer's Coordinating Center's Uniform Data Set. Alzheimer Dis Assoc Disord. 2018 Oct-Dec;32(4):351-358. doi: 10.1097/WAD.0000000000000279.
- Background: PubMed 33215852Staffaroni AM, Asken BM, Casaletto KB, Fonseca C, You M, Rosen HJ, Boxer AL, Elahi FM, Kornak J, Mungas D, Kramer JH. Development and validation of the Uniform Data Set (v3.0) executive function composite score (UDS3-EF). Alzheimers Dement. 2021 Apr;17(4):574-583. doi: 10.1002/alz.12214. Epub 2020 Nov 20.
- Derived from this study: PubMed 39692213Kern KC, Vohra M, Thirion ML, Wang DJJ, Wilcock DM, Thompson JF, Rosenberg GA, Sagare A, Moghekar A, Lu H, Lee T, Elahi FM, Satizabal CL, Tracy R, Seshadri S, Schwab K, Helmer K, Singh H, Kivisakk P, Greenberg SM, Vossel K, Kramer JH, Maillard P, DeCarli CS, Hinman JD. White matter free water mediates the associations between placental growth factor, white matter hyperintensities, and cognitive status. Alzheimers Dement. 2025 Feb;21(2):e14408. doi: 10.1002/alz.14408. Epub 2024 Dec 18.
- Individual participant dataSharing planned: Yes. MarkVCID research openly shares both within and outside the MarkVCID Consortium to the greatest extent practical. As per the MarkVCID Consortium's Charter, MarkVCID investigators are granted broad access to MarkVCID data, samples, analytic tools, and other resources with relevant permissions in place. MarkVCID data and samples may also be shared with external collaborators in compliance with the Consortium's external data sharing policies outlined in the MarkVCID Data Use Agreement. The process for requesting data and biosamples is described below.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven M. Greenberg, MD, PhD principal investigator
Massachusetts General Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment and Dementia, run by Massachusetts General Hospital at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVD progression as measured by decline in global cognition (time frame: The cognitive battery is implemented, and global cognition calculated, at Baseline and Years 1, 2 and 3 post-baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06284213, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.