Clinical trial NCT02726906: Lifestyle Enriching Activities for Research in Neuroscience Intervention Trial: LEARNit Study
Official title: Lifestyle Enriching Activities for Research in Neuroscience Intervention Trial: LEARNit Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Cognitive Ability, General
Keywords: Alzheimer's disease
Mild Cognitive Impairment
Brain Imaging
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 66
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female
2. English-speaking
3. 55-80 years old
4. Exhibits sedentary behavior
5. 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. Ability to complete both MRI and PET scans
10. 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 (GDS \< 8 of 15)
8. Inability to perform intervention (e.g., inability to walk without assistance)
9. Contraindications to MRI scan (e.g., pacemaker)

Primary outcomes:
measure: Functional Magnetic Resonance Imaging (fMRI) Brain Scan as a Measure of Brain Function
timeFrame: Baseline and Follow-up at 6 months
measure: Mnemonic Similarity Test as a Measure of Memory (Cognition)
timeFrame: Baseline and Follow-up at 6 months
Secondary outcomes:
measure: Amyloid Positron Emission Tomography (PET) Scan as a Measure of Tracer Binding (SUVr)
timeFrame: Baseline and Follow-up at 6 months
measure: Single-stage Treadmill Test
timeFrame: Baseline and Follow-up at 6 months
measure: Modified Physical Function Test
timeFrame: Baseline and Follow-up at 6 months
measure: Brain-derived Neurotropic Factor (BDNF) as a Measure From Blood
timeFrame: Baseline and Follow-up at 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References: