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Completed

NCT Number: NCT02726906

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

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.

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Key information

Conditions

Aging Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Ability, General Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female
  • English-speaking
  • 55-80 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

Exclusion criteria

  • 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)

Treatment and study plan

Moderate-aerobic walking

Behavioral

Positron Emission Tomography (PET) scan

Radiation

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

Healthy Living Education

Behavioral

Physical activity monitor

Device

Wrist device that will track daily physical activity

Primary outcomes

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

    Time frame: Baseline and Follow-up at 6 months

    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.

  2. Mnemonic Similarity Test as a Measure of Memory (Cognition)

    Time frame: Baseline and Follow-up at 6 months

    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.

Secondary outcomes

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

    Time frame: Baseline and Follow-up at 6 months

    Each participant received PET scans with Neuraceq [florbetaben F 18 (FBB)] to measure amyloid-beta PET binding. IV injections of the tracers (FBB, -8.11 6 0.6 mCi) were done outside of the scanning room. Four 5-min frames were acquired 90 minutes after injection.

  2. Single-stage Treadmill Test

    Time frame: Baseline and Follow-up at 6 months

    This is a measure of cardiovascular fitness. This test has been validated against peak VO2 max with r=0.96. Heart rate response is monitored with a Polar heart rate monitor and the heart rate at the end of the 4 min test is used to estimate VO2max using an established equation for conversion. The theoretical range for this outcome is 0 to 200 with higher scores indicating better cardiovascular fitness.

  3. Modified Physical Function Test

    Time frame: Baseline and Follow-up at 6 months

    This test is a measure of multiple domains related to functional activities of daily living. Each physical activity in score is of varying difficulty level. The theoretical range for this outcome is 0 to 36 with higher scores indicating better physical function.

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

    Time frame: Baseline and Follow-up at 6 months

    We will quantitatively analyze pre- and post-measurements of brain derived neurotrophic factor (BDNF). BDNF has been shown to increase after exercise intervention in humans and peripheral increases in these hormones correlate to cell proliferation in the dentate gyrus of the hippocampus. We measure total BDNF from plasma.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2016
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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