- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02001441
UCLA Fitness and Memory Study of Activity In Mild Cognitive Impairment (AIM) (AIM)
April 30, 2018 updated by: David Merrill, MD, PhD, University of California, Los Angeles
Physical Activity Levels and Hippocampal Sub-region Structure in MCI
This project will examine the relationship between physical activity levels, brain structure and memory function in adults with Mild Cognitive Impairment (MCI) aged 60 to 75.
The study will follow 30 adults with age-associated memory impairment or MCI over the course of 18 months.
During this time, subjects' physical activity levels will be measured regularly and related to both the thickness their hippocampus and to their memory performance.
Subjects will be recruited and screened for major health problems at UCLA.
Physical activity will be tracked for two weeks using accelerometers at baseline and every 6 months during the study.
At baseline and at the end of the study, subjects will undergo a structural MRI brain scan to measure hippocampal thickness, as well as a neuropsychological evaluation to measure memory function.
The study will seek to determine the relationship between physical activity level, hippocampal thickness and memory performance in older adults with age-associated memory impairment.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
35
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90095
- UCLA Longevity Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
56 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Southern California Residents with memory complaints aged 60-89.
Description
Inclusion Criteria:
- Agreement to participate in the study
- 60-89 years of age
- Diagnostic criteria for Mild Cognitive Impairment diagnosis: subjective memory complaints, Montreal Cognitive Assessment score of <26, intact instrumental activities of daily living (Smith et al., 1996) OR subjective age-associated memory complaints
- Cohabitation with an adult capable of ensuring correct usage of the physical activity monitors during the study and verifying self-reports of activity levels.
- Adequate visual and auditory acuity to allow neuropsychological testing.
- Screening laboratory tests and EKG without significant abnormalities that might interfere with the study. If screening laboratory tests or EKG show abnormalities, PI may request clearance from primary care physician before subject continues in study.
Exclusion Criteria:
- Comorbid conditions impacting mobility
- Current, untreated depression: BDI-II score >13
- Diagnosis of probable Alzheimer's disease (AD) or any other dementia (e.g., vascular, Lewy body, frontotemporal).
- Evidence of other neurological or physical illness that can produce cognitive deterioration. Volunteers with a history of head trauma, stroke, TIA, carotid bruits, or lacunes on MRI scans will be excluded.
- Contraindication to the MRI including claustrophobia, metal in body, surgery within 60 days, certain medical implants or previous abnormal MRI results.
- History of cardiovascular disease
- Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100)
- Current diagnosis of any major psychiatric disorder according to the DSM-IV TR criteria (APA, 2000), including current alcoholism or substance addiction.
- Current use of marijuana
- Previous use of marijuana for at least 15 days in a month, initiating use during adolescence and continuing for at least one year
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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No treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Activity level correlation with hippocampal thickness
Time Frame: 18 months
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Correlation of activity levels, as measured using ankle accelerometers, with hippocampal thickness, as measured using brain Magnetic Resonance Imaging (MRI).
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18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Activity level correlation with memory performance
Time Frame: 18 months
|
Correlation of activity levels, as measured using ankle accelerometers, with memory performance, as measured by neuropsychological evaluations
|
18 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Baseline measures prediction of follow-up measures
Time Frame: 18 months
|
Change in ankle accelerometer, brain MRI and neuropsychological data from baseline to 18 months
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18 months
|
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Activity level correlation with other measures controlling for other factors
Time Frame: 18 months
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Changes in ankle accelerometer data compared to changes in brain MRI and neuropsychological data from baseline to 18 months
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18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David Merrill, MD, PhD, University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
November 27, 2013
First Submitted That Met QC Criteria
November 27, 2013
First Posted (Estimate)
December 4, 2013
Study Record Updates
Last Update Posted (Actual)
May 2, 2018
Last Update Submitted That Met QC Criteria
April 30, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-000781
- UL1TR000124 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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