Cerebrovascular DiseaseMCI/CVDNCT01924312
Early Detection and Prevention of Mild Cognitive Impairment Due to Cerebrovascular Disease
A study testing Heart Health Intervention in people with Cerebrovascular Disease and Mild Cognitive Impairment, run by Gregory Jicha, 323-5550 at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Cerebrovascular Disease, Mild Cognitive Impairment
- What is being tested?
- Heart Health Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cerebrovascular Disease, Mild Cognitive Impairment
- Being tested
- Heart Health Intervention
- Keywords
- stroke, dementia, hypertension, diabetes, hyperlipidemia, smoking, obesity
- Medical subject headings
- Cerebrovascular Disorders, Cognitive Dysfunction, Stroke, Dementia, Hypertension, Diabetes Mellitus, Hyperlipidemias, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Health InterventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Heart Health Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 36 months
Secondary outcomes (2)
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
Measured: 36 months
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startMay 2013
- Primary completion30 Jun 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gregory Jicha, 323-5550
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gregory Jicha, 323-5550, University of Kentucky
- Investigators
- Gregory A. Jicha, MD, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924312
- Sponsor's protocol ID
- R01NR141892
- Other IDs
- 12-0837-F2L
- Acronym
- MCI/CVD
- Status last verified
- Oct 2019
- First submitted
- 2 Jul 2013
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Prevention of Mild Cognitive Impairment Due to Cerebrovascular Disease
- ClinicalTrials.gov ID
- NCT01924312
- Acronym / sponsor ID
- MCI/CVD / R01NR141892
- Conditions
- Cerebrovascular Disease, Mild Cognitive Impairment
- Keywords
- stroke, dementia, hypertension, diabetes, hyperlipidemia, smoking, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Gregory Jicha, 323-5550University, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 16 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention | Placebo comparator | Behavioral: Heart Health InterventionA 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. |
| Treatment Group | Experimental | Behavioral: Heart Health InterventionA 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart Health InterventionA 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). | Behavioural | No Intervention, Treatment Group |
Primary outcome
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.
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
2 secondary outcomes
Montreal Cognitive Assessment (MOCA)
Time frame: 36 months
Total brain volume
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory A. Jicha, MD, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Health Intervention in people with Cerebrovascular Disease and Mild Cognitive Impairment, run by Gregory Jicha, 323-5550 at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
California Verbal Learning Test- Delayed Recall (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.