Alzheimer Disease
Conditions
Brief summary
In the current study, we will examine how two types of concentration meditation practices affect plasma biomarkers of Alzheimer's Disease (AD). We will also examine the effects of the two types of meditation practices on emotional well-being and episodic memory. Healthy adults aged 18-35 who meet all eligibility criteria will be invited to this study. Participants will be asked to engage in one week of daily meditation practice or no-intervention control task at home. They will also be asked to visit the lab twice, once before and once after the intervention, to provide blood samples to assess plasma biomarkers of AD and to complete emotion questionnaires and a memory test.
Interventions
BEHAVIORALBelly-focus meditation
Participants will engage in concentration meditation for 40 minutes every day for a week. They will focus on the sensations around the belly.
BEHAVIORALBelly-focus meditation with slow breathing
Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week. They will focus on the sensations around the belly while breathing slowly.
Sponsors
University of California, Irvine
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Fluent in English * Aged between 18-35 years old * Agree to provide blood samples * Healthy adults who weigh at least 110 pounds * Agree to devote 40 minutes daily to this study for a week
Exclusion criteria
* Have a disorder that would affect heart rhythm or function (e.g., abnormal cardiac rhythm, dyspnea, heart disease including coronary artery disease, angina and arrhythmia) * Regularly practicing any relaxation, meditation or yoga that involve breathing focused practices lasting for more than an hour each week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Plasma Amyloid Beta (Aβ) Levels | Measured from blood draws before and after a one-week intervention | The investigators computed an aggregate Z-score based on plasma Aβ40 and Aβ42 levels (pg/mL). A Z-score of 0 represents the sample mean. Higher values indicate a greater level of plasma Aβ, which in cognitively normal individuals has been found to be associated with a higher risk of converting to Alzheimer's disease (Song et al., 2011). They conducted a 2 (time: pre, post) × 3 (condition) ANOVA to test for a time × condition interaction in plasma Aβ levels, assessing group differences in change over time. |
| Change in Plasma Ab42/40 Ratio | Measured from blood draws before and after a one-week intervention | The investigators conducted a 2 (time: pre, post) × 3 (condition) ANOVA to test for an interaction effect on plasma Ab42/40 ratios. The plasma Ab42/40 ratio was calculated by dividing the plasma Ab42 concentration (pg/ml) by the plasma Ab40 concentration (pg/ml). A higher plasma Ab42/40 ratio indicates better outcome (i.e., greater brain clearance). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Plasma pTau-181/Tau Ratio | Measured from blood draws before and after a one-week intervention | The investigators conducted a 2 (time: pre, post) × 3 (condition) ANOVA to test for an interaction effect on plasma pTau-181/total Tau ratios. The plasma pTau-181/total Tau ratio was calculated by dividing the plasma pTau-181 concentration (pg/ml) by the plasma total Tau concentration (pg/ml). A higher plasma pTau-181/total Tau ratio indicates better outcome (i.e., greater brain clearance). |
| Change in Emotional Well-being | Measured before and after a one-week intervention | The investigators conducted a 2 (time: pre, post) × 3 (condition) ANOVA to test for an interaction effect on emotional well-being. Emotional well-being was assessed using the Profile of Mood States (POMS), which consists of 40 items rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). Total Mood Disturbance (TMD) scores were calculated by summing the negative mood items and subtracting the sum of the positive mood items. A constant of 100 was added to the TMD score to eliminate negative values. Higher scores indicate more negative mood states, with possible scores ranging from 56 to 216. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Episodic Memory | Measured after a one-week intervention | The investigators will conduct a one-way ANOVA to assess group differences in episodic memory. |
Countries
United States
Participant flow
Pre-assignment details
Out of the 94 participants enrolled, 2 dropped before condition assignment.
Participants by arm
| Arm | Count |
|---|---|
| Belly-focus Concentration Meditation Participants will engage in concentration meditation for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly.
Belly-focus meditation: Participants will engage in concentration meditation for 40 minutes every day for a week. They will focus on the sensations around the belly. | 30 |
| Belly-focus Concentration Meditation With Slow Breathing Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly while breathing slowly.
Belly-focus meditation with slow breathing: Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week. They will focus on the sensations around the belly while breathing slowly. | 32 |
| No-intervention Control Participants will rest quietly for 40 minutes every day for a week while recording heart rate. | 30 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Belly-focus Concentration Meditation | Belly-focus Concentration Meditation With Slow Breathing | No-intervention Control | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 32 Participants | 30 Participants | 92 Participants |
| Age, Continuous | 25.07 years STANDARD_DEVIATION 5.16 | 26.25 years STANDARD_DEVIATION 5.29 | 26.20 years STANDARD_DEVIATION 4.82 | 25.73 years STANDARD_DEVIATION 5.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 13 Participants | 8 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 18 Participants | 22 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 9 Participants | 10 Participants | 32 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 3 Participants | 0 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 8 Participants | 6 Participants | 14 Participants |
| Race (NIH/OMB) White | 9 Participants | 8 Participants | 10 Participants | 27 Participants |
| Region of Enrollment United States | 30 participants | 32 participants | 30 participants | 92 participants |
| Sex: Female, Male Female | 24 Participants | 26 Participants | 25 Participants | 75 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 5 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 32 | 0 / 30 |
| other Total, other adverse events | 3 / 30 | 0 / 32 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 32 | 0 / 30 |
Outcome results
Primary
Change in Plasma Ab42/40 Ratio
The investigators conducted a 2 (time: pre, post) × 3 (condition) ANOVA to test for an interaction effect on plasma Ab42/40 ratios. The plasma Ab42/40 ratio was calculated by dividing the plasma Ab42 concentration (pg/ml) by the plasma Ab40 concentration (pg/ml). A higher plasma Ab42/40 ratio indicates better outcome (i.e., greater brain clearance).
Time frame: Measured from blood draws before and after a one-week intervention
Population: Population analyzed is composed by all randomization subjects who completed pre- and post-intervention blood draw and whose data quality was sufficient for data analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belly-focus concentration meditation | Change in Plasma Ab42/40 Ratio | post | 0.05 ratio of Aβ42 to Aβ40 | Standard Error 0.002 |
| Belly-focus concentration meditation | Change in Plasma Ab42/40 Ratio | pre | 0.05 ratio of Aβ42 to Aβ40 | Standard Error 0.002 |
| Belly-focus concentration meditation with slow breathing | Change in Plasma Ab42/40 Ratio | pre | 0.05 ratio of Aβ42 to Aβ40 | Standard Error 0.001 |
| Belly-focus concentration meditation with slow breathing | Change in Plasma Ab42/40 Ratio | post | 0.05 ratio of Aβ42 to Aβ40 | Standard Error 0.001 |
| No-intervention control | Change in Plasma Ab42/40 Ratio | pre | 0.05 ratio of Aβ42 to Aβ40 | Standard Error 0.001 |
| No-intervention control | Change in Plasma Ab42/40 Ratio | post | 0.05 ratio of Aβ42 to Aβ40 | Standard Error 0.002 |
p-value: 0.46ANOVA
Primary
Change in Plasma Amyloid Beta (Aβ) Levels
The investigators computed an aggregate Z-score based on plasma Aβ40 and Aβ42 levels (pg/mL). A Z-score of 0 represents the sample mean. Higher values indicate a greater level of plasma Aβ, which in cognitively normal individuals has been found to be associated with a higher risk of converting to Alzheimer's disease (Song et al., 2011). They conducted a 2 (time: pre, post) × 3 (condition) ANOVA to test for a time × condition interaction in plasma Aβ levels, assessing group differences in change over time.
Time frame: Measured from blood draws before and after a one-week intervention
Population: Population analyzed is composed by all randomization subjects who completed pre- and post-intervention blood draw and whose data quality was sufficient for data analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belly-focus concentration meditation | Change in Plasma Amyloid Beta (Aβ) Levels | pre | -0.38 Z-score | Standard Error 0.19 |
| Belly-focus concentration meditation | Change in Plasma Amyloid Beta (Aβ) Levels | post | -0.08 Z-score | Standard Error 0.17 |
| Belly-focus concentration meditation with slow breathing | Change in Plasma Amyloid Beta (Aβ) Levels | pre | 0.02 Z-score | Standard Error 0.17 |
| Belly-focus concentration meditation with slow breathing | Change in Plasma Amyloid Beta (Aβ) Levels | post | -0.29 Z-score | Standard Error 0.16 |
| No-intervention control | Change in Plasma Amyloid Beta (Aβ) Levels | pre | 0.24 Z-score | Standard Error 0.18 |
| No-intervention control | Change in Plasma Amyloid Beta (Aβ) Levels | post | 0.22 Z-score | Standard Error 0.16 |
p-value: 0.003ANOVA
Secondary
Change in Emotional Well-being
The investigators conducted a 2 (time: pre, post) × 3 (condition) ANOVA to test for an interaction effect on emotional well-being. Emotional well-being was assessed using the Profile of Mood States (POMS), which consists of 40 items rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). Total Mood Disturbance (TMD) scores were calculated by summing the negative mood items and subtracting the sum of the positive mood items. A constant of 100 was added to the TMD score to eliminate negative values. Higher scores indicate more negative mood states, with possible scores ranging from 56 to 216.
Time frame: Measured before and after a one-week intervention
Population: Population analyzed is composed by all randomization subjects who completed the emotional well-being survey (i.e., POMS) at pre- and post-intervention and whose data quality was sufficient for data analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belly-focus concentration meditation | Change in Emotional Well-being | pre | 87.15 score on a scale | Standard Error 2.29 |
| Belly-focus concentration meditation | Change in Emotional Well-being | post | 89.89 score on a scale | Standard Error 2.93 |
| Belly-focus concentration meditation with slow breathing | Change in Emotional Well-being | post | 84.68 score on a scale | Standard Error 2.73 |
| Belly-focus concentration meditation with slow breathing | Change in Emotional Well-being | pre | 87.39 score on a scale | Standard Error 2.14 |
| No-intervention control | Change in Emotional Well-being | post | 94.96 score on a scale | Standard Error 2.99 |
| No-intervention control | Change in Emotional Well-being | pre | 94.73 score on a scale | Standard Error 2.34 |
p-value: 0.952ANOVA
Secondary
Change in Plasma pTau-181/Tau Ratio
The investigators conducted a 2 (time: pre, post) × 3 (condition) ANOVA to test for an interaction effect on plasma pTau-181/total Tau ratios. The plasma pTau-181/total Tau ratio was calculated by dividing the plasma pTau-181 concentration (pg/ml) by the plasma total Tau concentration (pg/ml). A higher plasma pTau-181/total Tau ratio indicates better outcome (i.e., greater brain clearance).
Time frame: Measured from blood draws before and after a one-week intervention
Population: Population analyzed is composed by all randomization subjects who completed pre- and post-intervention blood draw and whose data quality was sufficient for data analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belly-focus concentration meditation | Change in Plasma pTau-181/Tau Ratio | pre | 5.30 ratio of pTau-181 to total Tau | Standard Error 0.38 |
| Belly-focus concentration meditation | Change in Plasma pTau-181/Tau Ratio | post | 4.73 ratio of pTau-181 to total Tau | Standard Error 0.37 |
| Belly-focus concentration meditation with slow breathing | Change in Plasma pTau-181/Tau Ratio | pre | 4.78 ratio of pTau-181 to total Tau | Standard Error 0.37 |
| Belly-focus concentration meditation with slow breathing | Change in Plasma pTau-181/Tau Ratio | post | 5.29 ratio of pTau-181 to total Tau | Standard Error 0.36 |
| No-intervention control | Change in Plasma pTau-181/Tau Ratio | pre | 5.02 ratio of pTau-181 to total Tau | Standard Error 0.38 |
| No-intervention control | Change in Plasma pTau-181/Tau Ratio | post | 4.64 ratio of pTau-181 to total Tau | Standard Error 0.37 |
p-value: 0.127ANOVA
Other Pre-specified
Episodic Memory
The investigators will conduct a one-way ANOVA to assess group differences in episodic memory.
Time frame: Measured after a one-week intervention