Early Detection and Prevention of Mild Cognitive Impairment Due to Cerebrovascular Disease
Early Detection and Prevention of Mild Cognitive Impairment Due to Cerebrovascular Disease
Vascular risk factors may account for up to 80% of the memory and thinking problems
 experienced by our aging population today, 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. Successful completion of project aims will allow an integrated
 understanding of mild cognitive impairment caused by vascular risks (MCI-CVD) with the
 potential for tremendous impact on one of the major healthcare crises facing the nation
 today.

 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. Each participant will be
 randomized into one of two groups (40 in each group) and followed over 36 months. One group
 will be followed to allow us to understand the natural history of memory and thinking
 impairment, while the other group will receive intensive education and assistance with
 vascular risk factor (CVD) control.
This is a randomized, controlled study of intensive medical management and educational
 programming (Heart Health Intervention) for controlling stroke and vascular risks that may
 impact your thinking and memory (MCI-CVD). This means that if you choose to enroll, it will
 be determined by chance ( pulling a number from a hat) whether you will receive the study
 intervention or standard-of-care treatment. One-half of all subjects will be enrolled in the
 intervention, while the other one half will not. You will have a 50:50 chance of receiving
 the intervention, like the flip of a coin. You will be in the study for 36 months if you
 enroll.

 Even if you do are not in the study group receiving medical management and educational
 programs, we will be monitoring your risks for stroke and vascular risks every 6 months and
 this information will be provided to your primary doctors, potentially resulting in an
 increased level of care as a result of your participation in this study.

 You must have an individual (spouse, friend, or relative), called a "study partner", who is
 willing to accompany you to all of the study visits or be available by telephone to
 communicate changes in your health status over the period of this study.

 The study visits include checking vital signs (blood pressure, heart rate weight), regular
 blood testing at 6 month intervals to monitor your vascular risks (blood sugar, cholesterol
 levels)as well as ensure your safety throughout the study, yearly brain imaging with MRI
 scans, and optional spinal fluid collection at enrollment and end of study to help us
 understand brain changes that cannot be measured in blood.
Inclusion Criteria:

 1. At least 1 of the following vascular risk factors or on treatment for 1 of these
 conditions determined by the study physicians to be responsible for the mild memory
 and thinking problems you experience:

 1. poorly controlled hypertension (systolic blood pressure>130mmHg) or prior history
 of hypertension associated with congestive heart failure (CHF)

 2. poorly controlled cholesterol (LDL > 70 mg/dL or triglycerides > 150 mg/dL)

 3. cardiomyopathy/congestive heart failure with an ejection fraction < 40%

 4. diabetes with fasting glucose > 110 mg/dL or glycosylated hemoglobin(HgbA1c) >
 7.0%

 5. homocysteine > 12umol/L

 6. history of stroke or transient ischemic attack (TIA)

 7. tobacco use > 30 pk/yr history

 8. BMI > 30

 2. Age > 55 years

 3. Memory complaint

 4. Montreal Cognitive Assessment (MoCA)score ≤ 26

 5. Either, presence of strategic (caudate, thalamus, subcortical white matter lacunar
 infarcts or mild to moderate small vessel ischemic changes (T2-positive) felt to be
 sufficient to explain the cognitive decline (in the clinical judgment of the examining
 physician)

 6. English-speaking

 Exclusion Criteria:

 1. Functional decline due to cognitive impairment, sufficient to meet clinical criteria
 for dementia

 2. Other medical, non-CVD causes of cognitive decline including but not limited to
 thyroid dysfunction, vitamin B12 deficiency, renal failure with blood urea nitrogen
 (BUN) > 30 mg/dL, ammonia > 50 mg/dL, other significant electrolyte abnormalities,
 extreme hypo (< 70 mg/dL) or hyper-glycemia (> 300mg/dL)…ect.

 3. Evidence for comorbid, non-vascular neurologic disease on clinical exam or on imaging
 (i.e. parkinsonism, focal neurologic deficits, amyotrophic lateral sclerosis(ALS),
 focal brain lesions other than small lacunar infarcts,…)

 4. Focal motor, sensory, visual or auditory deficits that would interfere with cognitive
 assessments or are suggestive of other brain pathology

 5. Vision and hearing with or without assistive devices sufficient to complete study
 protocol including cognitive test procedures