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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03754608
Other study ID # 2000023733
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 7, 2018
Est. completion date August 31, 2020

Study information

Verified date April 2021
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date August 31, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 90 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
MRI 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.

Locations

Country Name City State
United States Yale University School of Medicine New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic Odds ratio for the MRI vascular cognitive impairment biomarker. This will be calculated from the sensitivity and specificity as compared to clinical diagnosis. 2 years
Secondary Correlation between the biomarker and cognition Assess whether the biomarker can predict the severity of the cognitive performance. 18 months.
See also
  Status Clinical Trial Phase
Completed NCT03847779 - Microcirculatory Vasomotor Changes in Type 2 Diabetes With Peripheral Neuropathy N/A