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Early Detection and Prevention of Mild Cognitive Impairment Due to Cerebrovascular Disease (MCI/CVD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01924312
Recruitment Status : Completed
First Posted : August 16, 2013
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Gregory Jicha, 323-5550, University of Kentucky

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cerebrovascular Disease Mild Cognitive Impairment Behavioral: Heart Health Intervention Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Detection and Prevention of Mild Cognitive Impairment Due to Cerebrovascular Disease
Actual Study Start Date : May 2013
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2019
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: No Intervention
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
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).
Experimental: Treatment Group
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
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).


Outcome Measures
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Primary Outcome Measures :
  1. California Verbal Learning Test- Delayed Recall [ Time Frame: 36 months ]
    Memory test for a word list after 30 minutes delay will be compared between baseline and end of study visit.

  2. Brain T2 hyperintensity volume on MRI [ Time Frame: 36 months ]
    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


Secondary Outcome Measures :
  1. Montreal Cognitive Assessment (MOCA) [ Time Frame: 36 months ]
    The MOCA is a brief cognitive screen that will be compared between baseline and end of study for the interventional group compared to the placebo group

  2. Total brain volume [ Time Frame: 36 months ]
    Magnetic resonance imaging of the brain at baseline and end of study will be compared to determine rate of atrophy between the intervention and placebo group.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924312


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40504
Sponsors and Collaborators
Gregory Jicha, 323-5550
Investigators
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Principal Investigator: Gregory A. Jicha, MD, PhD University of Kentucky
More Information
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Responsible Party: Gregory Jicha, 323-5550, Gregory A. Jicha, MD, PhD, University of Kentucky
ClinicalTrials.gov Identifier: NCT01924312    
Other Study ID Numbers: R01NR141892
12-0837-F2L ( Other Identifier: Univeristy of Kentucky )
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gregory Jicha, 323-5550, University of Kentucky:
stroke, dementia, hypertension, diabetes, hyperlipidemia, smoking, obesity
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases