Lifestyle Enriching Activities for Research in Neuroscience Intervention Trial: LEARNit Study

NCT02726906 | Completed Results

• 1 other identifier: AG046928
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effects of modifiable lifestyle factors including exercise and healthy living on brain health. The investigators will compare 2 types of interventions, moderate aerobic walking vs. healthy living education, over 6 months to evaluate changes in brain health, cognition, and physical function in older adults with cognitive concerns.

Conditions

Aging; Cognitive Ability, General

Keywords

Alzheimer's disease; Mild Cognitive Impairment; Brain Imaging

Outcome Measures

Primary Outcomes (2)

• Functional Magnetic Resonance Imaging (fMRI) Brain Scan as a Measure of Brain Function

  Functional MRI has proven to be an effective non-invasive, in-vivo tool for measuring brain function via the BOLD signal. Growing evidence supports that fMRI BOLD can detect neuronal changes that occur very early in the disease process. The hippocampus has been shown to be a selectively vulnerable region in AD, and several studies, including our own, identified a aberrant brain signal in the hippocampus in older adults. The typical range for this outcome is -10 to 10 with higher scores indicating better brain function.

  Baseline and Follow-up at 6 months

• Mnemonic Similarity Test as a Measure of Memory (Cognition)

  The participants will encode a series of objects presented on a computer. Following the encoding period, they will begin their fMRI scan and be asked to indicate if they recognize the objects on the screen, which include targets (previously seen objects), lures (objects that are similar to previously seen objects) and novel (unrelated objects). The discrimination between Targets and Lures will indicate the rate at which participants "correctly reject" the Lures (via pattern separation) or "false alarm" to the Lures (via pattern completion). The theoretical range for this outcome is -1 to 1 with higher scores indicating better memory function.

  Baseline and Follow-up at 6 months

Secondary Outcomes (4)

• Amyloid Positron Emission Tomography (PET) Scan as a Measure of Tracer Binding (SUVr)

  Baseline and Follow-up at 6 months

• Single-stage Treadmill Test

  Baseline and Follow-up at 6 months

• Modified Physical Function Test

  Baseline and Follow-up at 6 months

• Brain-derived Neurotropic Factor (BDNF) as a Measure From Blood

  Baseline and Follow-up at 6 months

Study Arms (2)

Moderate-aerobic walking

EXPERIMENTAL

Participants will complete a 6-month home-based moderate-aerobic walking program of 150 minutes per week with the assistance of an interventionist.

Behavioral: Moderate-aerobic walking; Radiation: Positron Emission Tomography (PET) scan; Device: Physical activity monitor

Healthy Living Education

PLACEBO COMPARATOR

Participants will receive monthly topics on healthy living lifestyles for self-paced reading over 6 months with the assistance of an interventionist.

Radiation: Positron Emission Tomography (PET) scan; Behavioral: Healthy living education; Device: Physical activity monitor

Interventions

Moderate-aerobic walking BEHAVIORAL

Moderate-aerobic walking

Positron Emission Tomography (PET) scan RADIATION

Radioligand that binds to proteins using a PET/CT scanner.

Healthy Living Education; Moderate-aerobic walking

Healthy living education BEHAVIORAL

Healthy Living Education

Physical activity monitor DEVICE

Wrist device that will track daily physical activity

Healthy Living Education; Moderate-aerobic walking

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• English-speaking
• years old
• Exhibits sedentary behavior
• Objective cognitive impairment
• Mini-Mental State Exam score \> 26
• Perform at least 1 standard deviations below normative values on cognitive tests
• Absence of dementia
• Ability to complete both MRI and PET scans
• Physically capable of completing health programs

You may not qualify if:

• Baseline dementia
• History of a neurological disorder
• Current psychiatric illness
• Head trauma with a loss of consciousness \> 10 minutes
• Severe sensory deficits
• Substance abuse
• Depression (GDS \< 8 of 15)
• Inability to perform intervention (e.g., inability to walk without assistance)
• Contraindications to MRI scan (e.g., pacemaker)

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90032, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

Our study experienced delays due to the Covid-19 pandemic and impact on research. The human subjects portions of the trial were paused from March 2020 to August 2020 (a 5-month period of no human research activities on campus) due to local university Covid-19 restrictions. Once the pause was lifted, we were able to resume normal day to day activities with precautions in place, and have since completed the trial.

Results Point of Contact

• Title: Judy Pa, PhD
• Organization: UC San Diego

jpa@ucsd.edu

858-246-1333

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: April 4, 2016
• Study Start: August 21, 2016
• Primary Completion: July 13, 2022
• Study Completion: July 15, 2022
• Last Updated: October 2, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available starting July 1, 2025 and for at least 3 years.

Locations

US (1)