Status:
COMPLETED
Aerobic Exercise Training in Mild Cognitive Impairment Study
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
55-80 years
Phase:
NA
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 wi...
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 Da...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01146717
Start Date
March 1 2010
End Date
September 1 2016
Last Update
February 7 2020
Active Locations (1)
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1
UT Southwestern ADC/Institute for Exercise and Environmental Medicine
Dallas, Texas, United States, 75231