NCT02001441

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

November 27, 2013

Last Update Submit

April 30, 2018

Conditions

Keywords

Physical Activity, Aging, Memory, Cognitive Impairment, MRI, Neuroscience

Outcome Measures

Primary Outcomes (1)

  • Activity level correlation with hippocampal thickness

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

    18 months

Secondary Outcomes (1)

  • Activity level correlation with memory performance

    18 months

Other Outcomes (2)

  • Baseline measures prediction of follow-up measures

    18 months

  • Activity level correlation with other measures controlling for other factors

    18 months

Study Arms (1)

No treatment

Eligibility Criteria

Age60 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Southern California Residents with memory complaints aged 60-89.

You may qualify if:

  • Agreement to participate in the study
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Longevity Center

Los Angeles, California, 90095, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Cognitive DysfunctionMotor Activity

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBehavior

Study Officials

  • David Merrill, MD, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 27, 2013

First Posted

December 4, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

May 2, 2018

Record last verified: 2018-04

Locations