Early Detection and Prevention of Mild Cognitive Impairment Due to Cerebrovascular Disease
Completed · Not applicable
Conditions studied: Cerebrovascular Disease, Mild Cognitive Impairment
In brief
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.
Key facts
- Study ID
- NCT01924312
- Run by
- Gregory Jicha, 323-5550
- People needed
- 80
- Starts
- 2013-05-01
- Expected to finish
- 2019-06-30
- Last updated by the study team
- 2019-10-09
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- poorly controlled hypertension (systolic blood pressure>130mmHg) or prior history of hypertension associated with congestive heart failure (CHF)
- poorly controlled cholesterol (LDL > 70 mg/dL or triglycerides > 150 mg/dL)
- cardiomyopathy/congestive heart failure with an ejection fraction < 40%
- diabetes with fasting glucose > 110 mg/dL or glycosylated hemoglobin(HgbA1c) > 7.0%
- homocysteine > 12umol/L
- history of stroke or transient ischemic attack (TIA)
- tobacco use > 30 pk/yr history
- BMI > 30
- Age > 55 years
- Memory complaint
- Montreal Cognitive Assessment (MoCA)score ≤ 26
- 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)
- English-speaking
You may not qualify if…
- Functional decline due to cognitive impairment, sufficient to meet clinical criteria for dementia
- 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.
- 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,…)
- Focal motor, sensory, visual or auditory deficits that would interfere with cognitive assessments or are suggestive of other brain pathology
- Vision and hearing with or without assistive devices sufficient to complete study protocol including cognitive test procedures
Where it is running
- University of Kentucky — Lexington, Kentucky, United States
Full record on ClinicalTrials.gov
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