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CompletedNCT03754608Updated Apr 19, 2021

Validating Imaging Biomarkers of Small Vessel Disease in Diabetic Individuals Using Advanced MRI Techniques.

An observational study in Small Vessel Disease of Diabetes Mellitus, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 55 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-19.

Sponsored by Yale University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
63
Ages
55 Years to 90 Years
Sex
All
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Study summary

To develop a set of biomarkers for imaging of small vessel disease in diabetic individuals using advanced MRI techniques. With this the investigators want to document progression of disease both radiologically and clinically.

Read the detailed description

The investigators will use a paradigm developed at Yale University called Cognitive Predictive Modelling (CPM) which takes connectivity data and reduces it to two smaller network which predict higher and lower performance in a particular task for which these networks have been optimized. Vascular measures will complement this measure.

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Conditions studied

  • Small Vessel Disease of Diabetes Mellitus

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In context

Diabetic Angiopathies

28 studies on the registry are indexed under Diabetic Angiopathies; 6 are open to participants now.

This study's enrollment of 63 is below the median of 123 across 12 observational studies indexed under Diabetic Angiopathies.

Browse Diabetic Angiopathies studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Our study population are those with type 2 diabetes in mid-life and old age, who may or may not have cognitive deficits, whose cognitive deficits (when present) cannot be better explained by other factors. We exclude those who are unable to have MRI or cognitive testing due to a variety of reasons.

Inclusion criteria

A - Vascular cognitive impairment:

  1. Presence of diabetes
  2. The International Society of Vascular Behavioral and Cognitive Disorders (VASCOG) criteria for vascular cognitive impairment
  3. Age between 55 and 90 (inclusive)
  4. Score on the Montreal Cognitive Assessment (MOCA) 15 to 23
  5. Presence of a responsible caregiver who will accompany mild cognitive impaired (MCI) subjects to all procedures.
  6. Evidence of vascular disease
  7. The patient should have a capacity to consent.
  8. English speakers

B- Cognitively normal elderly Subjects:

  1. Presence of diabetes
  2. Absence of National Institute on Aging (NIA) - Alzheimer's Association core clinical criteria for probable Alzheimer's Disease (AD) and VASCOG criteria for vascular cognitive impairment.
  3. Objective memory scores within normal range for age (do not meet MCI Subjects criterion 2)
  4. Age between 55 and 90 (inclusive)
  5. English speakers

Exclusion criteria

Exclusion Criteria:

  1. Any significant neurologic disease (other than vascular cognitive disease and stroke), such as Parkinson's disease, brain tumor, seizure disorder, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits.
  2. Any significant systemic disease including hepatic failure, heart failure, renal failure, Chronic obstructive pulmonary disease (COPD), active infection and autoimmune disease.
  3. Any significant systemic illness or unstable medical condition, including: uncontrolled or insulin-dependent diabetes mellitus, uncorrected hypothyroidism or hyperthyroidism, or systemic cancer.
  4. Investigational agents are prohibited 4 weeks prior to entry and for the duration of the study. Previous treatment with an investigational small molecule with anti-amyloid properties or passive immunization against amyloid within 1 year of study entry. Previous treatment with an active immunization against amyloid.
  5. History of schizophrenia or other major psychiatric disorder (DSM IV criteria).
  6. History of alcohol or substance abuse or dependence (DSM IV criteria) within the past 2 years.
  7. Pregnancy, as determined by screening pregnancy tests for pre-menopausal females
  8. Impairment of visual or auditory acuity sufficient to interfere with study procedures.
  9. Education level \< 6 years.
  10. Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body. The presence of claustrophobia, precluding MRI.
  11. Drink more than 5 alcoholic drinks per week or any heavy drinking days in the last 30 days
  12. Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives [oral, implant, injection, patch, or ring], contraceptive sponge, double barrier [diaphragm or condom plus spermicide], or intrauterine device (IUD)
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
63 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Diabetics/No cognitive impairment

    These are individuals with diabetes who do not have vascular cognitive impairment as determined by VASCOG criteria.

    Diagnostic Test: MRI including cf-MRI, DTI, ASL and CVR.

  • Diabetics with vascular cognitive impairment

    These are individuals with diabetes who have vascular cognitive impairment as determined by VASCOG criteria.

    Diagnostic Test: MRI including cf-MRI, DTI, ASL and CVR.

Interventions

  • Diagnostic testMRI including cf-MRI, DTI, ASL and CVR.

    A paradigm developed at Yale University called Cognitive Predictive Modelling which takes connectivity data and reduces it to two smaller network which predict higher and lower performance in a particular task for which these networks have been optimized. This will be supplemented by MRI vascular measures.

    Also known as: Neuropsychological testing (Cantab), basic laboratory blood tests, small number of CSF

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What researchers measure

Primary outcomes

  1. Diagnostic Odds ratio for the MRI vascular cognitive impairment biomarker.

    This will be calculated from the sensitivity and specificity as compared to clinical diagnosis.

    Time frame: 2 years

Secondary outcomes

  1. Correlation between the biomarker and cognition

    Assess whether the biomarker can predict the severity of the cognitive performance.

    Time frame: 18 months.

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Study locations

1 site
  • Yale University School of Medicine
    New Haven, Connecticut 06510, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03754608
Lead sponsor
Yale University
Responsible party
Sponsor
First posted
Nov 27, 2018
Start date
Nov 7, 2018
Primary completion
Aug 31, 2020
Completion
Aug 31, 2020
Last update
Apr 19, 2021

Study contacts

Arash Salardini, MD
principal investigator · Yale University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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