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

Yale University1 site in 1 country63 target enrollmentNovember 7, 2018

ConditionsSmall Vessel Disease of Diabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Small Vessel Disease of Diabetes Mellitus
Sponsor: Yale University
Enrollment: 63
Locations: 1
Primary Endpoint: Diagnostic Odds ratio for the MRI vascular cognitive impairment biomarker.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

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.

Registry

clinicaltrials.gov

Start Date

November 7, 2018

End Date

August 31, 2020

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Yale University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A - Vascular cognitive impairment:
•Presence of diabetes
•The International Society of Vascular Behavioral and Cognitive Disorders (VASCOG) criteria for vascular cognitive impairment
•Age between 55 and 90 (inclusive)
•Score on the Montreal Cognitive Assessment (MOCA) 15 to 23
•Presence of a responsible caregiver who will accompany mild cognitive impaired (MCI) subjects to all procedures.
•Evidence of vascular disease
•The patient should have a capacity to consent.
•English speakers
•B- Cognitively normal elderly Subjects:

Exclusion Criteria

•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.
•Any significant systemic disease including hepatic failure, heart failure, renal failure, Chronic obstructive pulmonary disease (COPD), active infection and autoimmune disease.
•Any significant systemic illness or unstable medical condition, including: uncontrolled or insulin-dependent diabetes mellitus, uncorrected hypothyroidism or hyperthyroidism, or systemic cancer.
•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.
•History of schizophrenia or other major psychiatric disorder (DSM IV criteria).
•History of alcohol or substance abuse or dependence (DSM IV criteria) within the past 2 years.
•Pregnancy, as determined by screening pregnancy tests for pre-menopausal females
•Impairment of visual or auditory acuity sufficient to interfere with study procedures.
•Education level \< 6 years.
•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.