Clinical trial NCT01924312: Early Detection and Prevention of Mild Cognitive Impairment Due to Cerebrovascular Disease
Official title: Early Detection and Prevention of Mild Cognitive Impairment Due to Cerebrovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Disease
Mild Cognitive Impairment
Keywords: stroke, dementia, hypertension, diabetes, hyperlipidemia, smoking, obesity
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2013-08-16
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: California Verbal Learning Test- Delayed Recall
timeFrame: 36 months
measure: Brain T2 hyperintensity volume on MRI
timeFrame: 36 months
Secondary outcomes:
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: 36 months
measure: Total brain volume
timeFrame: 36 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Gregory A. Jicha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: