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Completed

NCT Number: NCT02001441

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

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.

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Key information

Age range

60 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCLA Longevity Center

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Activity level correlation with hippocampal thickness

    Time frame: 18 months

    Correlation of activity levels, as measured using ankle accelerometers, with hippocampal thickness, as measured using brain Magnetic Resonance Imaging (MRI).

Secondary outcomes

  1. 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

Other outcomes

  1. 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

  2. Activity level correlation with other measures controlling for other factors

    Time frame: 18 months

    Changes in ankle accelerometer data compared to changes in brain MRI and neuropsychological data from baseline to 18 months

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

Physical Activity Levels and Hippocampal Sub-region Structure in MCI

Acronym: AIM

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 4, 2013
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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