NCT03754608已完成不适用
Validating Imaging Biomarkers of Small Vessel Disease in Diabetic Individuals Using Advanced MRI Techniques.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Diagnostic Odds ratio for the MRI vascular cognitive impairment biomarker.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Diagnostic Odds ratio for the MRI vascular cognitive impairment biomarker.
时间窗: 2 years
This will be calculated from the sensitivity and specificity as compared to clinical diagnosis.
次要结局
- Correlation between the biomarker and cognition(18 months.)
研究者
研究点 (1)
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