Skip to main content
OpenTrials
Completed

NCT Number: NCT03754608

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MRI including cf-MRI, DTI, ASL and CVR.

Diagnostic Test

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.

Other names: Neuropsychological testing (Cantab), basic laboratory blood tests, small number of CSF

Primary outcomes

  1. Diagnostic Odds ratio for the MRI vascular cognitive impairment biomarker.

    Time frame: 2 years

    This will be calculated from the sensitivity and specificity as compared to clinical diagnosis.

Secondary outcomes

  1. Correlation between the biomarker and cognition

    Time frame: 18 months.

    Assess whether the biomarker can predict the severity of the cognitive performance.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 27, 2018
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.