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

Primary Purpose

Cerebrovascular Disease, Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heart Health Intervention
Sponsored by
Gregory Jicha, 323-5550
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Disease focused on measuring stroke, dementia, hypertension, diabetes, hyperlipidemia, smoking, obesity

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

No Intervention

Treatment Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Montreal Cognitive Assessment (MOCA)
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
Total brain volume
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.

Full Information

First Posted
July 2, 2013
Last Updated
October 6, 2019
Sponsor
Gregory Jicha, 323-5550
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1. Study Identification

Unique Protocol Identification Number
NCT01924312
Brief Title
Early Detection and Prevention of Mild Cognitive Impairment Due to Cerebrovascular Disease
Acronym
MCI/CVD
Official Title
Early Detection and Prevention of Mild Cognitive Impairment Due to Cerebrovascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gregory Jicha, 323-5550

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disease, Mild Cognitive Impairment
Keywords
stroke, dementia, hypertension, diabetes, hyperlipidemia, smoking, obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Intervention
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Heart Health Intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
California Verbal Learning Test- Delayed Recall
Description
Memory test for a word list after 30 minutes delay will be compared between baseline and end of study visit.
Time Frame
36 months
Title
Brain T2 hyperintensity volume on MRI
Description
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
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MOCA)
Description
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
Time Frame
36 months
Title
Total brain volume
Description
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.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory A. Jicha, MD, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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