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

NCT ID: NCT02001441

Last Updated: 2018-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No treatment

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Merrill, MD, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Merrill, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UCLA Longevity Center

Los Angeles, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.semel.ucla.edu/longevity/research

Longevity Center Research Laboratory

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UL1TR000124

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-000781

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.