UCLA Fitness and Memory Study (AIM)

This study has been terminated.
(Fitness Tracking Device No Longer Available)
Sponsor:
Information provided by (Responsible Party):
David Merrill, MD, PhD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02001441
First received: November 27, 2013
Last updated: December 2, 2015
Last verified: December 2015
  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.

Condition
Mild Cognitive Impairment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physical Activity Levels and Hippocampal Sub-region Structure in MCI

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Activity level correlation with hippocampal thickness [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Correlation of activity levels, as measured using ankle accelerometers, with hippocampal thickness, as measured using brain Magnetic Resonance Imaging (MRI).


Secondary Outcome Measures:
  • Activity level correlation with memory performance [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Correlation of activity levels, as measured using ankle accelerometers, with memory performance, as measured by neuropsychological evaluations


Other Outcome Measures:
  • Baseline measures prediction of follow-up measures [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Change in ankle accelerometer, brain MRI and neuropsychological data from baseline to 18 months

  • Activity level correlation with other measures controlling for other factors [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Changes in ankle accelerometer data compared to changes in brain MRI and neuropsychological data from baseline to 18 months


Biospecimen Retention:   Samples With DNA
Whole blood

Estimated Enrollment: 30
Study Start Date: August 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment

  Eligibility

Ages Eligible for Study:   60 Years to 89 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Southern California Residents with memory complaints aged 60-89.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02001441

Locations
United States, California
UCLA Longevity Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: David Merrill, MD, PhD University of California, Los Angeles
  More Information

Additional Information:
Responsible Party: David Merrill, MD, PhD, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02001441     History of Changes
Other Study ID Numbers: 13-000781  UL1TR000124 
Study First Received: November 27, 2013
Last Updated: December 2, 2015
Health Authority: United States: National Institutes of Health
United States: UCLA Clinical and Translational Science Institute

Keywords provided by University of California, Los Angeles:
Physical Activity, Aging, Memory, Cognitive Impairment, MRI, Neuroscience

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2016