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Early Detection and Prevention of Mild Cognitive Impairment Due to Cerebrovascular Disease

Active, not recruiting

This study will examine how vascular risk factors cause memory and thinking problems in older adults with mild cognitive impairment, and whether reducing vascular risk factors can prevent such problems. Participants will be randomly chosen to be followed naturally by researchers or to receive intensive education and assistance with vascular risk-factor control.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years N/A Both No
May 2013
June 2019
80

At least one of the following vascular risk factors or treatment for one of these conditions, determined by the study physicians to be responsible for mild memory and thinking problems:

  • poorly controlled hypertension (systolic blood pressure >130mmHg) or prior history of hypertension associated with congestive heart failure
  • poorly controlled cholesterol (LDL >70 mg/dL or triglycerides >150 mg/dL)
  • cardiomyopathy/congestive heart failure with an ejection fraction <40 percent
  • diabetes with fasting glucose >110 mg/dL or glycosylated hemoglobin(HgbA1c) >7.0 percent
  • homocysteine >12umol/L
  • history of stroke or transient ischemic attack
  • tobacco use
  • body mass index >30
  • Memory complaint (Montreal Cognitive Assessment score ≤26 )
  • Strategic caudate, thalamus, or subcortical white-matter lacunar infarcts or mild to moderate small-vessel ischemic changes sufficient to explain cognitive decline
  • English-speaking
  • Adequate vision and hearing, with or without assistive devices, to complete study procedures

  • Functional decline due to cognitive impairment, sufficient to meet clinical criteria for dementia
  • Other medical, noncardiovascular causes of cognitive decline, including but not limited to: thyroid dysfunction, vitamin B12 deficiency, renal failure with blood urea nitrogen >30 mg/dL, ammonia >50 mg/dL, other significant electrolyte abnormalities, extreme hypoglycemia (<70 mg/dL) or hyperglycemia (>300 mg/dL)
  • Evidence of comorbid, nonvascular neurologic disease found on clinical exam or on imaging (for example, parkinsonism, focal neurologic deficits, amyotrophic lateral sclerosis, focal brain lesions other than small lacunar infarcts
  • Motor, sensory, visual, or auditory deficits that would interfere with cognitive assessments or suggset other brain pathology

Vascular risk factors may account for up to 80% of the memory and thinking problems experienced by the aging population, by far in excess of that caused by Alzheimer's disease. By doing this study, we hope to learn how vascular risk factors cause memory and thinking changes in the elderly, and whether we can prevent memory and thinking changes by reducing these risk factors.

The study will enroll 80 participants with memory and thinking problems (mild cognitive impairment; MCI) and are at risk for stroke and further difficulties with memory and thinking that may eventually lead to disability and a diagnosis of dementia. Half of participants will receive intensive medical management and educational programming (Heart Health Intervention) for controlling stroke and vascular risks that may impact thinking and memory. The other half (the control group) will be monitored for risk of stroke and vascular disease every 6 months, with information provided to their primary care doctors. The study lasts 3 years. Visits include checking vital signs (blood pressure, heart rate, weight), regular blood testing at every 6 months to monitor vascular risks (blood sugar, cholesterol levels), yearly brain imaging with magnetic resonance imaging scans, and spinal fluid collection at enrollment and the end of the study to help researchers understand brain changes that cannot be measured in blood.

Name City State Zip Status Primary Contact
University of Kentucky
Lexington Kentucky 40504

University of Kentucky

Name Role Affiliation
Gregory A. Jicha, MD, PhD Principal Investigator University of Kentucky

Name Phone Email
Jacqueline A. Towner 859-323-3104 jacqueline.towner@uky.edu
Sarah D. Tarrant 859-323-1331 sarah.tarrant@uky.edu

NCT01924312

Early Detection and Prevention of Mild Cognitive Impairment Due to Cerebrovascular Disease