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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Aging, Cognitive Ability, General

Intervention / Treatment
-----------------
* Behavioral: Moderate-aerobic walking
* Radiation: Positron Emission Tomography (PET) scan
* Behavioral: Healthy living education
* Device: Physical activity monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate-aerobic walking<br>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<br> <br> Radiation: Positron Emission Tomography (PET) scan<br>* Radioligand that binds to proteins using a PET/CT scanner.<br>Device: Physical activity monitor<br>* Wrist device that will track daily physical activity<br>|
| Placebo Comparator: Healthy Living Education<br>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<br>* Radioligand that binds to proteins using a PET/CT scanner.<br>Behavioral: Healthy living education<br> <br> Device: Physical activity monitor<br>* Wrist device that will track daily physical activity<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Magnetic Resonance Imaging (fMRI) brain scan as a measure of brain function |  | 6 months | 
| Mnemonic Similarity Test as a measure of memory (cognition) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positron Emission Tomography (PET) scan as a measure of tracer binding |  | 6 months | 
| Single-stage treadmill test and modified physical function test as measures of physical function |  | 6 months | 
| Brain-derived neurotropic factor (BDNF) as a measure from blood |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease, Mild Cognitive Impairment, Brain Imaging