Aerobic Exercise Training in Mild Cognitive Impairment Study (AETMCI)
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Balance training
Sponsored by
About this trial
This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Exercise
Eligibility Criteria
Inclusion Criteria:
- Age 55-80 years old, Male or Female
- Control Subjects: absence of cognitive complaints and normal performance in Uniform Data Set (UDS) neuropsychological tests.
- For patients: Diagnosis of amnestic MCI (single and multiple domains) by Petersen's criteria (as modified for ADNI-GO study).
- Stable medical condition for > 6 months
- Sable medications for >2 months (use of cholinesterase inhibitors, or prior use of multivitamins is allowed)
- Caregiver/informant available to accompany patient for scheduled visits in case the patient develops cognitive impairment that interferes with independent study participation.
- Fluency of patient and caregiver in English
- Ability to return to clinic for additional visits over a 12 month period.
- ≥ 10 years of education or enough work history to exclude mental retardation.
- Adequate visual and auditory acuity to allow neuropsychological testing.
- Screening laboratory tests and ECG without significant abnormalities that might interfere with the study.
- Physical ability to undergo endurance exercise training.
Exclusion Criteria:
- Diagnosis of Alzheimer's Disease or other type of dementia.
- Participant enrolled in any other investigational drug study within 2 months or longer, depending on the investigational drug half-life.
- Modified Hachinski Score ≥ 4.
- Subject has history in the past 2 years of epileptic seizures, or DSM-IV criteria of any major psychiatric disorders.
- Past history or MRI evidence of brain damage including significant trauma, stroke, hydrocephalus, mental retardation or serious neurological disorder.
- Carotid stent or sever stenosis.
- Significant history of active alcoholism or drug abuse.
- History of myocardial infarction within the previous year. Unstable cardiac, renal, lung, liver or other severe chronic diseases.
- Uncontrolled hypertension (Systolic Blood Pressure (SBP) ≥160, Diastolic Blood Pressure (DBP) ≥100)or hypotension (SBP <100 mmHg).
- Currently diagnosed and being treated for Diabetes Mellitus (DM).
- Obesity with Body Mass Index (BMI) ≥ 35.
- History of familial early onset (<55 years old) dementia
- Pacemaker or other medical device of metal that precludes performing MRI.
- Subjects who have been engaged in moderate intensity aerobic exercise training for > 30 minutes, 3 times per week over the past 2 years.
- History of a clinical diagnosis of B12 deficiency or hypothyroidism. (stable treatment for at least 3 months is allowed).
- Chronic inflammatory diseases including, lupus, rheumatoid arthritis and polymyalgia rheumatica.
Prohibited Medications:
- narcotics
- anti-Parkinsonian medications
- anti-convulsants for treatment of seizure disorder
drugs that can influence psychometric test results.
- Subjects on a statins or non-steroidal anti-inflammatory drug (NSAID) are eligible but must be on a stable dose for at least 2 months.
Sites / Locations
- UT Southwestern ADC/Institute for Exercise and Environmental Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Exercise
Control group
Arm Description
Outcomes
Primary Outcome Measures
Cognitive function
A comprehensive battery of neuropsychological tests focused on memory and executive function will be used to assess effects of exercise on cognitive function.
Secondary Outcome Measures
Cerebrovascular function
Transcranial Doppler and perfusion magnetic resonance imaging (MRI) will be used to measure cerebrovascular function/brain perfusion before and after exercise training.
Brain tissue volume and white matter integrity
Magnetic resonance imaging (MRI) will be used to measure changes in brain volume and white matter integrity before and after exercise training.
Full Information
NCT ID
NCT01146717
First Posted
June 16, 2010
Last Updated
February 5, 2020
Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT01146717
Brief Title
Aerobic Exercise Training in Mild Cognitive Impairment Study
Acronym
AETMCI
Official Title
Mild Cognitive Impairment:Cerebrovascular Dysfunction and Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is being done to find out whether regulation of brain blood flow is altered in patents with mild cognitive impairment (those who have memory problems but otherwise healthy) when compared with healthy elderly individuals. In addition, this study will determine whether exercise training improves brain blood flow, brain structure, and brain function in patients with mild cognitive impairment (MCI).
This is a research study because at present the investigators know little about brain blood flow regulation in patients with mild cognitive impairment. The investigators also know little about whether exercise training improves brain blood flow, brain structure, and brain function in patients with mild cognitive impairment.
Detailed Description
We plan to study 70 patients with amnestic MCI and 30 healthy older adults with similar age, sex, and educational level in this research at the University of Texas Southwestern(UTSW) Medical Center Dallas and Texas Health Presbyterian Hospital Dallas - Institute for Exercise an Environmental Medicine (IEEM).
To help decide if you qualify to be in this study, the researchers may ask you questions about your health, including medications you take and any surgical procedures you have had. You may also have to fill out certain forms or have the following exams, tests or procedures. The screening process usually takes 2-3 hours.
You will be required to come for 7-9 visits including the initial screening for eligibility to participate in this study. The experiments will measure your brain perfusion, vascular function and exercise capacity.
For the healthy controls, the expected length of this study will be about 2-3 months including all the test visits. Your participation in this study will end following completion of your testing.
For those with Mild Cognitive Impairment, the expected length of this study will be about 18 months including all the test visits and exercise training. Your participation in this study will end following completion of your repeat testing after one-year exercise training or control intervention. On occasion, training may be delayed due to injury, illness or personal matters. If this is the case, your enrollment in the study may last longer than one year as we attempt to complete the training and testing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, Exercise
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Patients with mild cognitive impairment will undergo moderate intensity endurance exercise training for one year.
Intervention Type
Behavioral
Intervention Name(s)
Balance training
Intervention Description
A group of patients with mild cognitive impairment will perform flexibility and balance training for one year as a control group.
Primary Outcome Measure Information:
Title
Cognitive function
Description
A comprehensive battery of neuropsychological tests focused on memory and executive function will be used to assess effects of exercise on cognitive function.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Cerebrovascular function
Description
Transcranial Doppler and perfusion magnetic resonance imaging (MRI) will be used to measure cerebrovascular function/brain perfusion before and after exercise training.
Time Frame
One year
Title
Brain tissue volume and white matter integrity
Description
Magnetic resonance imaging (MRI) will be used to measure changes in brain volume and white matter integrity before and after exercise training.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 55-80 years old, Male or Female
Control Subjects: absence of cognitive complaints and normal performance in Uniform Data Set (UDS) neuropsychological tests.
For patients: Diagnosis of amnestic MCI (single and multiple domains) by Petersen's criteria (as modified for ADNI-GO study).
Stable medical condition for > 6 months
Sable medications for >2 months (use of cholinesterase inhibitors, or prior use of multivitamins is allowed)
Caregiver/informant available to accompany patient for scheduled visits in case the patient develops cognitive impairment that interferes with independent study participation.
Fluency of patient and caregiver in English
Ability to return to clinic for additional visits over a 12 month period.
≥ 10 years of education or enough work history to exclude mental retardation.
Adequate visual and auditory acuity to allow neuropsychological testing.
Screening laboratory tests and ECG without significant abnormalities that might interfere with the study.
Physical ability to undergo endurance exercise training.
Exclusion Criteria:
Diagnosis of Alzheimer's Disease or other type of dementia.
Participant enrolled in any other investigational drug study within 2 months or longer, depending on the investigational drug half-life.
Modified Hachinski Score ≥ 4.
Subject has history in the past 2 years of epileptic seizures, or DSM-IV criteria of any major psychiatric disorders.
Past history or MRI evidence of brain damage including significant trauma, stroke, hydrocephalus, mental retardation or serious neurological disorder.
Carotid stent or sever stenosis.
Significant history of active alcoholism or drug abuse.
History of myocardial infarction within the previous year. Unstable cardiac, renal, lung, liver or other severe chronic diseases.
Uncontrolled hypertension (Systolic Blood Pressure (SBP) ≥160, Diastolic Blood Pressure (DBP) ≥100)or hypotension (SBP <100 mmHg).
Currently diagnosed and being treated for Diabetes Mellitus (DM).
Obesity with Body Mass Index (BMI) ≥ 35.
History of familial early onset (<55 years old) dementia
Pacemaker or other medical device of metal that precludes performing MRI.
Subjects who have been engaged in moderate intensity aerobic exercise training for > 30 minutes, 3 times per week over the past 2 years.
History of a clinical diagnosis of B12 deficiency or hypothyroidism. (stable treatment for at least 3 months is allowed).
Chronic inflammatory diseases including, lupus, rheumatoid arthritis and polymyalgia rheumatica.
Prohibited Medications:
narcotics
anti-Parkinsonian medications
anti-convulsants for treatment of seizure disorder
drugs that can influence psychometric test results.
Subjects on a statins or non-steroidal anti-inflammatory drug (NSAID) are eligible but must be on a stable dose for at least 2 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rong Zhang, PhD
Organizational Affiliation
UTSW
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern ADC/Institute for Exercise and Environmental Medicine
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32083583
Citation
Pasha EP, Rutjes E, Tomoto T, Tarumi T, Stowe A, Claassen JAHR, Munro Cullum C, Zhu DC, Zhang R. Carotid Stiffness is Associated with Brain Amyloid-beta Burden in Amnestic Mild Cognitive Impairment. J Alzheimers Dis. 2020;74(3):925-935. doi: 10.3233/JAD-191073.
Results Reference
derived
PubMed Identifier
28750671
Citation
Stowe AM, Ireland SJ, Ortega SB, Chen D, Huebinger RM, Tarumi T, Harris TS, Cullum CM, Rosenberg R, Monson NL, Zhang R. Adaptive lymphocyte profiles correlate to brain Abeta burden in patients with mild cognitive impairment. J Neuroinflammation. 2017 Jul 27;14(1):149. doi: 10.1186/s12974-017-0910-x.
Results Reference
derived
Links:
URL
http://ieemphd.com/
Description
Related Info
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Aerobic Exercise Training in Mild Cognitive Impairment Study
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