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

Yale University

Status

Completed

Conditions

Small Vessel Disease of Diabetes Mellitus

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT03754608

2000023733

Details and patient eligibility

About

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.

Full 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.

Enrollment

63 patients

Sex

All

Ages

55 to 90 years old

Volunteers

Accepts Healthy Volunteers

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:

Presence of diabetes
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.
Objective memory scores within normal range for age (do not meet MCI Subjects criterion 2)
Age between 55 and 90 (inclusive)
English speakers

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.
Drink more than 5 alcoholic drinks per week or any heavy drinking days in the last 30 days
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)