Expired Study
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Los Angeles, California 90095


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

13-000781


NCT ID:

NCT02001441


Secondary ID:

UL1TR000124


Study Acronym:

AIM


Brief Title:

UCLA Fitness and Memory Study of Activity In Mild Cognitive Impairment (AIM)


Official Title:

Physical Activity Levels and Hippocampal Sub-region Structure in MCI


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

60 Years


Maximum Age:

89 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Los Angeles


Oversight Authority:

  • United States: National Institutes of Health
  • United States: UCLA Clinical and Translational Science Institute


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

35


Enrollment Type:

Actual


Overall Contact Information

Official Name:David Merrill, MD, PhD
Principal Investigator
University of California, Los Angeles

Study Dates

Start Date:August 2013
Completion Date:August 2015
Completion Type:Actual
Primary Completion Date:August 2015
Primary Completion Type:Actual
Verification Date:April 2018
Last Changed Date:April 30, 2018
First Received Date:November 27, 2013

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Activity level correlation with memory performance
Time Frame:18 months
Safety Issues:False
Description:Correlation of activity levels, as measured using ankle accelerometers, with memory performance, as measured by neuropsychological evaluations
Outcome Type:Primary Outcome
Measure:Activity level correlation with hippocampal thickness
Time Frame:18 months
Safety Issues:False
Description:Correlation of activity levels, as measured using ankle accelerometers, with hippocampal thickness, as measured using brain Magnetic Resonance Imaging (MRI).

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:No treatment

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Los Angeles

Samples and Retentions

Sample Retention:Samples With DNA
Description: Whole blood
Study Population: Southern California Residents with memory complaints aged 60-89.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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