Clinical trial: Validating Imaging Biomarkers of Small Vessel Disease in Diabetic Individuals Using Advanced MRI Techniques. (NCT03754608)

Eligibility criteria:
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)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
Subject must be at most 90 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Contradiction