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

Mild Cognitive Impairment Clinical Trial

— AIM  

Official title:

Physical Activity Levels and Hippocampal Sub-region Structure in MCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001441
• Other study ID #: 13-000781
• Secondary ID: UL1TR000124
• Status: Completed
• Start date: August 2013
• Est. completion date: August 2015

Study information

• Verified date: April 2018
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Locations

Country	Name	City	State
United States	UCLA Longevity Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Baseline measures prediction of follow-up measures	Change in ankle accelerometer, brain MRI and neuropsychological data from baseline to 18 months	18 months
Other	Activity level correlation with other measures controlling for other factors	Changes in ankle accelerometer data compared to changes in brain MRI and neuropsychological data from baseline to 18 months	18 months
Primary	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	Activity level correlation with memory performance	Correlation of activity levels, as measured using ankle accelerometers, with memory performance, as measured by neuropsychological evaluations	18 months

External Links

•   Longevity Center Research Laboratory