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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02726906
Recruitment Status : Recruiting
First Posted : April 4, 2016
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Judy Pa, University of Southern California

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.

Condition or disease Intervention/treatment Phase
Aging Cognitive Ability, General Behavioral: Moderate-aerobic walking Radiation: Positron Emission Tomography (PET) scan Behavioral: Healthy living education Device: Physical activity monitor Phase 2

Detailed Description:
Cognitive decline in older adults is a major public health issue. The cost of caring for older adults with substantial cognitive impairment, like those with Alzheimer's Disease in the US is approximately $200 billion a year, causing major societal, economic, and caregiving burden. Despite great advances towards diagnosing these problems, the discovery of effective treatments has been minimal. Exploring non-pharmacological interventions, such as exercise and healthy living, have gained momentum. These promising, modifiable lifestyle interventions have the potential for delaying disease onset and slowing decline in cognition. However, the therapeutic effect of lifestyle interventions in patients with mild cognitive impairment, a prime intervention period for treatment, is not well understood. Therefore, in this study, the investigators will examine brain, body, and cognitive changes in older adults who engage in moderate-aerobic walking or healthy living education.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lifestyle Enriching Activities for Research in Neuroscience Intervention Trial: LEARNit Study
Study Start Date : July 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Moderate-aerobic walking
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
Radioligand that binds to proteins using a PET/CT scanner.

Device: Physical activity monitor
Wrist device that will track daily physical activity

Placebo Comparator: Healthy Living Education
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
Radioligand that binds to proteins using a PET/CT scanner.

Behavioral: Healthy living education
Device: Physical activity monitor
Wrist device that will track daily physical activity




Primary Outcome Measures :
  1. Functional Magnetic Resonance Imaging (fMRI) brain scan as a measure of brain function [ Time Frame: 6 months ]
  2. Mnemonic Similarity Test as a measure of memory (cognition) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Positron Emission Tomography (PET) scan as a measure of tracer binding [ Time Frame: 6 months ]
  2. Single-stage treadmill test and modified physical function test as measures of physical function [ Time Frame: 6 months ]
  3. Brain-derived neurotropic factor (BDNF) as a measure from blood [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female
  2. English-speaking
  3. 60-80 years old
  4. Exhibits sedentary behavior
  5. Subjective or objective cognitive impairment
  6. Mini-Mental State Exam score > 26
  7. Perform at least 1 standard deviations below normative values on cognitive tests
  8. Absence of dementia
  9. Modified Hachinski score < 4
  10. Ability to complete both MRI and PET scans
  11. Physically capable of completing health programs

Exclusion Criteria:

  1. Baseline dementia
  2. History of a neurological disorder
  3. Current psychiatric illness
  4. Head trauma with a loss of consciousness > 10 minutes
  5. Severe sensory deficits
  6. Substance abuse
  7. Depression
  8. Inability to perform intervention (e.g., inability to walk without assistance)
  9. Contraindications to MRI scan (e.g., pacemaker)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726906


Contacts
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Contact: Lisette Isenberg, PhD 323-442-0141 learnstudy@ini.usc.edu

Locations
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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90032
Contact: Judy Pa, PhD    323-442-7246    judypa@usc.edu   
Contact: Lisette Isenberg, PhD    323-442-7246    lisenberg@usc.edu   
Sponsors and Collaborators
University of Southern California

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Responsible Party: Judy Pa, Assistant Professor of Neurology, University of Southern California
ClinicalTrials.gov Identifier: NCT02726906    
Other Study ID Numbers: AG046928
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Judy Pa, University of Southern California:
Alzheimer's disease
Mild Cognitive Impairment
Brain Imaging