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

NCT01924312 | Completed DMC

• 2 other identifiers: R01NR14189212-0837-F2L
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Disease; Mild Cognitive Impairment

Keywords

stroke, dementia, hypertension, diabetes, hyperlipidemia, smoking, obesity

Outcome Measures

Primary Outcomes (2)

• California Verbal Learning Test- Delayed Recall

  Memory test for a word list after 30 minutes delay will be compared between baseline and end of study visit.

  36 months

• Brain T2 hyperintensity volume on MRI

  Magnetic resonance brain imaging will be performed at enrollment and annually to end of study. Change in volumetric measurement of T2 signal hyperintensities(amount of vascular injury)will be determined for the intervention compared to the placebo group

  36 months

Secondary Outcomes (2)

• Montreal Cognitive Assessment (MOCA)

  36 months

• Total brain volume

  36 months

Study Arms (2)

No Intervention

PLACEBO COMPARATOR

A placebo cohort of 40 subjects with MCI related to vascular risk factors (MCI-CVD) will be followed longitudinally with cognitive, imaging, blood and optional spinal fluid biomarkers providing insight into the natural disease course of MCI-CVD. This natural history group will serve as the control group for the treatment arm described below.

Behavioral: Heart Health Intervention

Treatment Group

EXPERIMENTAL

A cohort of 40 subjects with MCI-CVD will be treated with a nursing-based educational program (Heart Health Intervention) including aggressive symptom monitoring and treatment of vascular risks in a 6 visit intervention block over 12 weeks after baseline and thereafter for every 6 months for the study duration of 3 years. These subjects will be followed identically to the subjects in the natural history arm described in the control group above with cognitive testing, imaging, blood, and optional spinal fluid testing.

Behavioral: Heart Health Intervention

Interventions

Heart Health Intervention BEHAVIORAL

A specialty CVD Risk Clinic will focus on education and individualized treatment programs to modify vascular risks in each subject using the methods developed, tested and shown to successfully reduce multiple CVD risk factors in the HeartHealth Program (HRSA grant, 1D1ARH1606, phase I and 2).

No Intervention; Treatment Group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Gregory Jicha, 323-5550: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40504, United States

Location

MeSH Terms

Conditions

Cerebrovascular Disorders; Cognitive Dysfunction; Stroke; Dementia; Hypertension; Diabetes Mellitus; Hyperlipidemias; Smoking; Obesity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Dyslipidemias; Lipid Metabolism Disorders; Behavior; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregory A. Jicha, MD, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Gregory A. Jicha, MD, PhD

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: August 16, 2013
• Study Start: May 1, 2013
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2019
• Last Updated: October 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)