Start: May 2013
End: June 30, 2019
What Is This Study About?
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.
Do I Qualify To Participate in This Study?
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
- Adequate vision and hearing, with or without assistive devices, to complete study procedures
Must NOT have:
- 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
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: University of Kentucky
Source: ClinicalTrials.gov ID: NCT01924312