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



Status:Recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:55 - 90
Updated:12/21/2018
Start Date:November 7, 2018
End Date:September 1, 2020
Contact:Arash Salardini, MD
Email:arash.salardini@yale.edu
Phone:203-785-4085

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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.

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.

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:

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)
We found this trial at
1
site
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Phone: 203-785-4085
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New Haven, CT
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