AgingNCT02726906
Lifestyle Enriching Activities for Research in Neuroscience Intervention Trial: LEARNit Study
A study testing Moderate-aerobic walking, Positron Emission Tomography (PET) scan and Healthy living education in people with Aging and Cognitive Ability, General, run by University of Southern California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Cognitive Ability, General
- What is being tested?
- Moderate-aerobic walking, Positron Emission Tomography (PET) scan and Healthy living education
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2016to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female
- English-speaking
- 55-80 years old
- Exhibits sedentary behavior
- Objective cognitive impairment
- Mini-Mental State Exam score > 26
Show all 10Show fewer
- 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
Who cannot join
- Baseline dementia
- History of a neurological disorder
- Current psychiatric illness
- Head trauma with a loss of consciousness > 10 minutes
- Severe sensory deficits
- Substance abuse
Show all 9Show fewer
- Depression (GDS < 8 of 15)
- Inability to perform intervention (e.g., inability to walk without assistance)
- Contraindications to MRI scan (e.g., pacemaker)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90032
About this 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.
Read the 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.
- Conditions
- Aging, Cognitive Ability, General
- Being tested
- Moderate-aerobic walking, Positron Emission Tomography (PET) scan, Healthy living education, Physical activity monitor
- Keywords
- Alzheimer's disease, Mild Cognitive Impairment, Brain Imaging
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-aerobic walkingBehavioural
Positron Emission Tomography (PET) scanRadiation
Radioligand that binds to proteins using a PET/CT scanner.
Healthy living educationBehavioural
Physical activity monitorDevice
Wrist device that will track daily physical activity
| Study group | Role | What they receive |
|---|---|---|
| Moderate-aerobic walking | Experimental | Participants will complete a 6-month home-based moderate-aerobic walking program of 150 minutes per week with the assistance of an interventionist. Receives: Behavioral: Moderate-aerobic walking; Radiation: Positron Emission Tomography (PET) scan; Device: Physical activity monitor |
| Healthy Living Education | Placebo comparator | Participants will receive monthly topics on healthy living lifestyles for self-paced reading over 6 months with the assistance of an interventionist. Receives: Radiation: Positron Emission Tomography (PET) scan; Behavioral: Healthy living education; Device: Physical activity monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Magnetic Resonance Imaging (fMRI) Brain Scan as a Measure of Brain Function
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.
Measured: Baseline and Follow-up at 6 months
Mnemonic Similarity Test as a Measure of Memory (Cognition)
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.
Measured: Baseline and Follow-up at 6 months
Secondary outcomes (4)
Amyloid Positron Emission Tomography (PET) Scan as a Measure of Tracer Binding (SUVr)
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.
Measured: Baseline and Follow-up at 6 months
Single-stage Treadmill Test
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.
Measured: Baseline and Follow-up at 6 months
Modified Physical Function Test
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.
Measured: Baseline and Follow-up at 6 months
Brain-derived Neurotropic Factor (BDNF) as a Measure From Blood
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.
Measured: Baseline and Follow-up at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study start21 Aug 2016
- Primary completion13 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judy Pa, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726906
- Sponsor's protocol ID
- AG046928
- Status last verified
- Sep 2024
- First submitted
- 28 Mar 2016
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: All data requests will be reviewed by the data committee. Approved investigators will be provided de-identified participant-level data from the trial as a .CSV file.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Enriching Activities for Research in Neuroscience Intervention Trial: LEARNit Study
- ClinicalTrials.gov ID
- NCT02726906
- Acronym / sponsor ID
- AG046928
- Conditions
- Aging, Cognitive Ability, General
- Keywords
- Alzheimer's disease, Mild Cognitive Impairment, Brain Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 21 Aug 2016 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate-aerobic walking | Experimental | Behavioral: Moderate-aerobic walking, Radiation: Positron Emission Tomography (PET) scan, Device: Physical activity monitorParticipants will complete a 6-month home-based moderate-aerobic walking program of 150 minutes per week with the assistance of an interventionist. |
| Healthy Living Education | Placebo comparator | Radiation: Positron Emission Tomography (PET) scan, Behavioral: Healthy living education, Device: Physical activity monitorParticipants will receive monthly topics on healthy living lifestyles for self-paced reading over 6 months with the assistance of an interventionist. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female
- English-speaking
- 55-80 years old
- Exhibits sedentary behavior
- Objective cognitive impairment
Key exclusion criteria (9 listed)
- Baseline dementia
- History of a neurological disorder
- Current psychiatric illness
- Head trauma with a loss of consciousness > 10 minutes
- Severe sensory deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate-aerobic walking | Behavioural | Moderate-aerobic walking |
| Positron Emission Tomography (PET) scanRadioligand that binds to proteins using a PET/CT scanner. | Radiation | Healthy Living Education, Moderate-aerobic walking |
| Healthy living education | Behavioural | Healthy Living Education |
| Physical activity monitorWrist device that will track daily physical activity | Device | Healthy Living Education, Moderate-aerobic walking |
Primary outcome
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.
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.
4 secondary outcomes
Amyloid Positron Emission Tomography (PET) Scan as a Measure of Tracer Binding (SUVr)
Time frame: Baseline and Follow-up at 6 months
Single-stage Treadmill Test
Time frame: Baseline and Follow-up at 6 months
Modified Physical Function Test
Time frame: Baseline and Follow-up at 6 months
Brain-derived Neurotropic Factor (BDNF) as a Measure From Blood
Time frame: Baseline and Follow-up at 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All data requests will be reviewed by the data committee. Approved investigators will be provided de-identified participant-level data from the trial as a .CSV file.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-aerobic walking, Positron Emission Tomography (PET) scan and Healthy living education in people with Aging and Cognitive Ability, General, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Magnetic Resonance Imaging (fMRI) Brain Scan as a Measure of Brain Function (time frame: Baseline and Follow-up at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.