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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726906
• Other study ID #: AG046928
• Status: Completed
• Phase: N/A
• Start date: August 21, 2016
• Est. completion date: July 15, 2022

Study information

• Verified date: December 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 15, 2022
• Est. primary completion date: July 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Aging
• Cognitive Ability, General

Intervention

Behavioral:
• Moderate-aerobic walking

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

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Magnetic Resonance Imaging (fMRI) brain scan as a measure of brain function		6 months
Primary	Mnemonic Similarity Test as a measure of memory (cognition)		6 months
Secondary	Positron Emission Tomography (PET) scan as a measure of tracer binding		6 months
Secondary	Single-stage treadmill test and modified physical function test as measures of physical function		6 months
Secondary	Brain-derived neurotropic factor (BDNF) as a measure from blood		6 months