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| Name | Class |
|---|---|
| University of California, Irvine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belly-focus concentration meditation | Experimental | 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. |
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| Belly-focus concentration meditation with slow breathing | Experimental | 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. |
|
| No-intervention control | No Intervention | Participants will rest quietly for 40 minutes every day for a week while recording heart rate. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belly-focus meditation | Behavioral | Participants will engage in concentration meditation for 40 minutes every day for a week. They will focus on the sensations around the belly. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured from blood draws before and after a one-week intervention |
| 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). | Measured from blood draws before and after a one-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Episodic Memory | The investigators will conduct a one-way ANOVA to assess group differences in episodic memory. | Measured after a one-week intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90089 | United States |
Out of the 94 participants enrolled, 2 dropped before condition assignment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | No-intervention Control | Participants will rest quietly for 40 minutes every day for a week while recording heart rate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Error | Z-score | Measured from blood draws before and after a one-week intervention |
|
One week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse events after blood draw | Blood and lymphatic system disorders | Systematic Assessment | Three participants reported mild events after blood draws: two had brief discomfort or bleeding; one fainted briefly, recovered after snacks, and was cleared by paramedics. All recovered fully; no serious adverse events occurred. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mara Mather | University of Southern California | (213) 821-1868 | mara.mather@usc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2023 | Oct 27, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 25, 2023 | Nov 4, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Belly-focus meditation with slow breathing | Behavioral | 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. |
|
| Measured from blood draws before and after a one-week intervention |
| 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. | Measured before and after a one-week intervention |
| BG001 | 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. |
| BG002 | No-intervention Control | Participants will rest quietly for 40 minutes every day for a week while recording heart rate. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
| OG002 | No-intervention control | Participants will rest quietly for 40 minutes every day for a week while recording heart rate. |
|
|
|
| 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). | 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. | Posted | Mean | Standard Error | ratio of Aβ42 to Aβ40 | Measured from blood draws before and after a one-week intervention |
|
|
|
|
| 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). | 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. | Posted | Mean | Standard Error | ratio of pTau-181 to total Tau | Measured from blood draws before and after a one-week intervention |
|
|
|
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| 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. | 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. | Posted | Mean | Standard Error | score on a scale | Measured before and after a one-week intervention |
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| Other Pre-specified | Episodic Memory | The investigators will conduct a one-way ANOVA to assess group differences in episodic memory. | Not Posted | Measured after a one-week intervention | Participants |
| 0 |
| 30 |
| 0 |
| 30 |
| 3 |
| 30 |
| EG001 | 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. | 0 | 32 | 0 | 32 | 0 | 32 |
| EG002 | No-intervention Control | Participants will rest quietly for 40 minutes every day for a week while recording heart rate. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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