Alzheimer Disease, Cognitive Impairment, Mild
Conditions
Brief summary
Evaluation of central nervous system penetration of orally administered Rapamune (RAPA) in older adults with Mild Cognitive Impairment (MCI) or early Alzheimer's disease (AD) and investigate associated safety, tolerability, target engagement, cognition, and functional status as initial proof-of-concept study
Detailed description
This study is an open-label pilot study of orally administered RAPA to measure its target engagement in Cerebrospinal Fluid (CSF) and blood, and to establish the feasibility and safety of RAPA treatment in older adults with MCI and early stage AD as initial proof-of-concept for a larger Phase 2 clinical trial.
Interventions
DRUGRapamune
Sirolimus 1mg capsules
Sponsors
National Center for Advancing Translational Sciences (NCATS)
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's disease, Global Clinical Dementia Rating Scale (CDR)=0.5-1 * Normal blood cell counts without clinically significant excursions; ; normal liver and renal function; and glucose control (HbA1c \< 6.5%). Lipid panel and PT/PTT/INR within normal limits * A Legally Authorized Representative (LAR) if necessary for consent * An LAR or study partner to accompany participant to all visits * Availability for all study visits * Stable dose of AD medications) Donepezil, rivastigmine, memantine, galantamine) for at least 3 months prior to the baseline visit
Exclusion criteria
* Diabetes (HbA1c≥6.5% or anti-diabetic medications) * History of skin ulcers or poor wound healing * Current tobacco or illicit drug use or alcohol abuse * Use of anti-platelet or anti-coagulant medications other than aspirin * Current medications that affect cytochrome P450 3A4; current or recent medications for hypertriglyceridemia (eg, Gemfibrozil) * Hypersensitivity or history of allergy to Rapamycin * Immunosuppressant therapy within the last year; current treatment with hydroxychloroquine and chloroquine (requires washout period of 14 days) * Chemotherapy or radiation treatment within the last year * Current or chronic history of liver disease or known hepatic or biliary abnormalities * History of primary hypertriglyceridemia. Abnormal triglycerides \>200 or LDL cholesterol \>193, or other abnormal labs deemed clinically significant upon investigator review * Current or chronic history of pulmonary disease or abnormal pulse oximetry (\<90%) * Chronic heart failure * Pregnancy * Recent history (past 6 months) of myocardial infarction, active coronary artery disease, intestinal disorders, stroke, or transient ischemic attack * significant neurological conditions other than AD * Poorly controlled blood pressure (systolic BP\>160, diastolic BP\>90mmHg) * Active inflammatory, COVID-19, autoimmune, infectious, hepatic, gastrointestinal, malignant, and/or psychiatric disease * History of, or Magnetic Resonance Imaging (MRI) positive for any space occupying lesion, including mass effect and/or abnormal intracranial pressure, which would indicate contraindication to lumbar puncture * Organ transplant recipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Brain Barrier Penetration of RAPA | Change from Baseline to 8 weeks | Lumbar punctures will be performed at baseline and after the final RAPA dose, to assess CSF levels of the drug. Change is calculated as value at 8 weeks minus the value at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Baseline to 8 weeks | Number of adverse events experienced across all 10 subjects after they were enrolled and randomized to treatment, regardless of relatedness to intervention. |
| Percentage of Study Drug Pills Taken | Baseline to 8 weeks | Average percentage of study drug pills taken across all 10 subjects after they were enrolled and randomized to treatment. The percentage of study drug pills taken was evaluated by having participants return any leftover study drug pills at each visit during the active treatment period. |
| Change in CSF AD Biomarkers From Baseline to 8 Weeks | Baseline to 8 weeks | Evaluation of CSF AD biomarkers. Change is calculated as value at 8 weeks minus the value at baseline. |
| Change in Plasma AD Biomarkers From Baseline to 8 Weeks | Baseline to 8 weeks | Evaluation of plasma AD biomarkers. Change is calculated as value at 8 weeks minus the value at baseline. |
| Change in CSF Inflammatory Markers From Baseline to 8 Weeks | Baseline to 8 weeks | Evaluation of CSF inflammatory markers. Change is calculated as value at 8 weeks minus the value at baseline. |
| Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | Baseline to 8 weeks | Evaluation of plasma inflammatory markers. Change is calculated as value at 8 weeks minus the value at baseline. |
| Safety Labs - Change in White Blood Cell and Platelet Counts From Baseline to 8 Weeks | Baseline to 8 weeks | Evaluation of safety labs - white blood cell and platelet counts. Change is calculated as value at 8 weeks minus the value at baseline. |
| Safety Labs - Change in Red Blood Cell Count | Baseline to 8 weeks | Evaluation of safety labs - red blood cell counts. Change in red blood cell count calculated as value at 8 weeks minus the value at baseline. |
| Safety Labs - Change in Mean Corpuscular Volume | 8 weeks | Evaluation of safety labs - Change in Mean Corpuscular volume. Change is calculated as value at 8 weeks minus the value at baseline |
| Safety Labs - Change in Mean Corpuscular Hemoglobin | 8-weeks | safety labs - Mean Corpuscular Hemoglobin. Change is calculated as value at 8 weeks minus the value at baseline. |
| Safety Labs - Change in Metabolic Parameters (g/dl) | 8 weeks | Evaluation of safety labs - metabolic parameters. Change is calculated as value at 8 weeks minus the value at baseline. |
| Safety Labs - Change in Hematocrit | 8 weeks | Evaluation of of safety labs - hematocrit. Change is calculated as value at 8 weeks minus the value at baseline. |
| Safety Labs - Change in Monocytes | 8 weeks | Evaluation of of safety labs - monocytes. Change is calculated as value at 8 weeks minus the value at baseline. |
| Safety Labs - Change in Red Cell Distribution Width | 8 weeks | Evaluation of of safety labs - Red cell distribution width. Change is calculated as value at 8 weeks minus the value at baseline. The value reported is % of red blood cell size and volume variability. |
| Safety Labs - Change in Hemoglobin A1c | 8 weeks | Evaluation of of safety labs - hemoglobin A1c. Change is calculated as value at 8 weeks minus the value at baseline. |
| Safety Labs - Change in Metabolic and Lipid Parameters (mg/dl) | 8 weeks | Evaluation of safety labs - metabolic and lipid parameters. Change is calculated as value at 8 weeks minus the value at baseline. |
| Safety Labs - Change in Sodium and Potassium (mmol/L) | 8 weeks | Evaluation of safety labs - sodium and potassium. Change is calculated as value at 8 weeks minus the value at baseline. |
| Safety Labs - Change in Liver Panel (iU/L) | 8 weeks | Evaluation of safety labs - liver panel. Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change in Montreal Cognitive Assessment (MoCA) | 8 weeks | The Montreal Cognitive Assessment (MoCA) assesses global cognition with scores ranging from 0 to 30 points. Higher scores indicate better performance.Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on the Clinical Rating Scale Global Score | 8 weeks | The Clinical Rating Scale Global Score assesses cognition and daily functioning with scores ranging from 0 to 3 points. Higher scores indicate worse cognition and/or functional status.Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on the Clinical Rating Scale Sum of Boxes Score | 8 weeks | The Clinical Rating Scale Sum of Boxes assesses cognition and daily functioning with scores ranging from 0 to 18 points. Higher scores indicate worse cognition and/or functional status.Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on the Hopkins Verbal Learning Test - Revised Immediate Recall | 8 weeks | The Hopkins Verbal Learning Test - Revised Immediate Recall assesses verbal list learning with scores ranging from 0 to 36 points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on the Hopkins Verbal Learning Test - Revised Delayed Recall | 8 weeks | The Hopkins Verbal Learning Test - Revised Delayed Recall assesses verbal list learning with scores ranging from 0 to 12 points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on the Craft Story Immediate Recall Verbatim | 8 weeks | The Craft Story Immediate Recall Verbatim assesses verbal narrative learning with scores ranging from 0 to 44 points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on the Craft Story Delayed Recall Verbatim | 8 weeks | The Craft Story Delayed Recall Verbatim assesses verbal memory recall with scores ranging from 0 to 44 points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on the Benson Figure Copy | 8 weeks | The Benson Figure Copy assesses visuoconstructional skills with scores ranging from 0 to 17points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on the Benson Figure Delayed Recall | 8 weeks | The Benson Figure Delayed Recall assesses visual memory with scores ranging from 0 to 17 points. Higher scores indicate better performance.Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on the Number Span Forward | 8 weeks | The Number Span Forward test assesses basic attention with scores ranging from 0 to 16 points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on the Number Span Backward | 8 weeks | The Number Span Backward test assesses working memory with scores ranging from 0 to 14 points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on the Trail Making Test Part A, Time to Completion | 8 weeks | The Trail Making Test Part A, time to completion assesses psychomotor speed and visual scanning with scores ranging from 1 to 150 seconds. Higher scores indicate worse performance. Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change Trail Making Test Part B, Time to Completion | 8 weeks | The Trail Making Test Part B, time to completion assesses attentional shifting with scores ranging from 1 to 300 seconds. Higher scores indicate worse performance. Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on Phonemic Fluency | 8 weeks | The Phonemic fluency test assesses speeded word generation to a phonemic cue. Scores begin at 0 with no upper limit. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on Semantic Fluency | 8 weeks | The Semantic fluency test assesses speeded word generation to a semantic cue. Scores begin at 0 with no upper limit. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on the Multilingual Naming Test | 8 weeks | The Multilingual Naming Test assesses confrontation naming. Scores range from 0 to 32 and higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on the Hayling, Total Errors | 8 weeks | The Hayling assesses response inhibition errors. Scores range from 0 to 30 and higher scores indicate worse performance. Change is calculated as value at 8 weeks minus the value at baseline. |
| Change in Vitals From Baseline to 8 Weeks | Baseline to 8 weeks | Evaluation of vitals. Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on Grip Strength, Non-dominant Hand | 8 weeks | The grip strength, non-dominant hand assesses grip strength in kilograms. Values begin at 0 with no upper limit. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on the Geriatric Depression Scale 15-item | 8 weeks | The Geriatric Depression Scale 15-item assesses depressive symptomatology. Scores range from 0 to 15 and higher scores indicate worse outcomes. Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on the Functional Activities Questionnaire | 8 weeks | The Functional Activities Questionnaire assesses functional status for independent activities of daily living. Scores range from 0 to 30 and higher scores indicate worse outcomes. Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on the Neuropsychiatric Inventory Questionnaire | 8 weeks | The Neuropsychiatric Inventory Questionnaire assesses neuropsychiatric symptoms. Scores range from 0 to 12 and higher scores indicate worse outcomes. Change is calculated as value at 8 weeks minus the value at baseline. |
| Cognition/Functional Status - Change on Grip Strength, Dominant Hand | 8 weeks | The grip strength, dominant hand assesses grip strength in kilograms. Values begin at 0 with no upper limit. Higher scores indicate better performance Change is calculated as value at 8 weeks minus the value at baseline. |
Countries
United States
Participant flow
Recruitment details
Subjects that were enrolled and passed eligibility screening and went on to randomization.
Participants by arm
| Arm | Count |
|---|---|
| RAPA Intervention Sirolimus 1mg orally once a day for 8 weeks
Rapamune: Sirolimus 1mg capsules | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | RAPA Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 74 years STANDARD_DEVIATION 4 |
| Diagnosis Early-stage dementia | 4 Participants |
| Diagnosis Mild cognitive impairment | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
Primary
Blood Brain Barrier Penetration of RAPA
Lumbar punctures will be performed at baseline and after the final RAPA dose, to assess CSF levels of the drug. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: Change from Baseline to 8 weeks
Population: HPLC/MS/MS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Blood Brain Barrier Penetration of RAPA | 0 ng/ml | Standard Deviation 0 |
Secondary
Adverse Events
Number of adverse events experienced across all 10 subjects after they were enrolled and randomized to treatment, regardless of relatedness to intervention.
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RAPA Intervention | Adverse Events | 20 Events |
Secondary
Change in CSF AD Biomarkers From Baseline to 8 Weeks
Evaluation of CSF AD biomarkers. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: Baseline to 8 weeks
Population: paired samples t-test comparing pre to post-treatment CSF ADRD biomarker levels
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RAPA Intervention | Change in CSF AD Biomarkers From Baseline to 8 Weeks | CSF GFAP | 6262.21 ng/ml | Standard Deviation 4928.96 |
| RAPA Intervention | Change in CSF AD Biomarkers From Baseline to 8 Weeks | CSF ptau-181 | 2.64 ng/ml | Standard Deviation 2.72 |
| RAPA Intervention | Change in CSF AD Biomarkers From Baseline to 8 Weeks | CSF abeta 40 | 615.57 ng/ml | Standard Deviation 1210.06 |
| RAPA Intervention | Change in CSF AD Biomarkers From Baseline to 8 Weeks | CSF Abeta42 | 21.52 ng/ml | Standard Deviation 62.12 |
| RAPA Intervention | Change in CSF AD Biomarkers From Baseline to 8 Weeks | CSF NFL | 367.18 ng/ml | Standard Deviation 310.71 |
Secondary
Change in CSF Inflammatory Markers From Baseline to 8 Weeks
Evaluation of CSF inflammatory markers. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: Baseline to 8 weeks
Population: paired samples t-test comparing pre to post-treatment CSF inflammatory values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | IL-6 | -0.02 pg/ml | Standard Deviation 0.25 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | IL-10 | 0.02 pg/ml | Standard Deviation 0.02 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | IL-8 | 5.76 pg/ml | Standard Deviation 9.1 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | TNF-α | 0.03 pg/ml | Standard Deviation 0.07 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | IL-12 | 0.35 pg/ml | Standard Deviation 0.53 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | IL-15 | 0.29 pg/ml | Standard Deviation 0.28 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | IL-16 | 0.63 pg/ml | Standard Deviation 3.4 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | IL-17a | 0.03 pg/ml | Standard Deviation 0.09 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | IL-1a | -0.15 pg/ml | Standard Deviation 0.33 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | IL-5 | 0.07 pg/ml | Standard Deviation 0.07 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | IL-7 | 0.004 pg/ml | Standard Deviation 0.1 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | VEGF-A | 0.95 pg/ml | Standard Deviation 2.37 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | VEGF-C | 266.60 pg/ml | Standard Deviation 575.93 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | VEGF-D | 109.64 pg/ml | Standard Deviation 117.23 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | Eotaxin | -5.05 pg/ml | Standard Deviation 32.4 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | Eotaxin-3 | -0.20 pg/ml | Standard Deviation 2.2 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | IP-10 | -12.93 pg/ml | Standard Deviation 143.87 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | MCP-1 | -22.56 pg/ml | Standard Deviation 78 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | MIP1-α | 0.83 pg/ml | Standard Deviation 2.9 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | sFLT-1 | 41.18 pg/ml | Standard Deviation 253.61 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | PIGF | 2.84 pg/ml | Standard Deviation 40.66 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | bFGF | -0.69 pg/ml | Standard Deviation 20.85 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | sVCAM1 | 21202.57 pg/ml | Standard Deviation 24439.62 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | sICAM1 | 6701.21 pg/ml | Standard Deviation 13402.98 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | SAA | -73762.91 pg/ml | Standard Deviation 375497.74 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | CRP | -98910.45 pg/ml | Standard Deviation 27540.81 |
| RAPA Intervention | Change in CSF Inflammatory Markers From Baseline to 8 Weeks | IFN-γ | 0.14 pg/ml | Standard Deviation 0.17 |
Secondary
Change in Plasma AD Biomarkers From Baseline to 8 Weeks
Evaluation of plasma AD biomarkers. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: Baseline to 8 weeks
Population: paired samples t-test comparing pre to post-treatment plasma ADRD biomarker levels
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RAPA Intervention | Change in Plasma AD Biomarkers From Baseline to 8 Weeks | plasma ptau-181 | -0.22 ng/ml | Standard Deviation 0.47 |
| RAPA Intervention | Change in Plasma AD Biomarkers From Baseline to 8 Weeks | plasma abeta 40 | -8.86 ng/ml | Standard Deviation 12.28 |
| RAPA Intervention | Change in Plasma AD Biomarkers From Baseline to 8 Weeks | Plasma Abeta42 | -0.67 ng/ml | Standard Deviation 0.69 |
| RAPA Intervention | Change in Plasma AD Biomarkers From Baseline to 8 Weeks | Plasma NFL | 0.84 ng/ml | Standard Deviation 4.64 |
| RAPA Intervention | Change in Plasma AD Biomarkers From Baseline to 8 Weeks | Plasma GFAP | -27.70 ng/ml | Standard Deviation 64.78 |
Secondary
Change in Plasma Inflammatory Markers From Baseline to 8 Weeks
Evaluation of plasma inflammatory markers. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: Baseline to 8 weeks
Population: paired samples t-test comparing pre to post-treatment plasma inflammatory biomarkers.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | bFGF | -143.67 pg/ml | Standard Deviation 174.71 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | sVCAM1 | 97456.61 pg/ml | Standard Deviation 1400309.82 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | IL-10 | -0.18 pg/ml | Standard Deviation 0.53 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | IL-6 | 0.29 pg/ml | Standard Deviation 0.54 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | IL-8 | 0.16 pg/ml | Standard Deviation 1.57 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | TNF-α | 0.06 pg/ml | Standard Deviation 0.44 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | IL-12 | -16.56 pg/ml | Standard Deviation 38.52 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | IL-15 | 0.12 pg/ml | Standard Deviation 0.31 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | IL-16 | 16.18 pg/ml | Standard Deviation 42.7 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | IL-17a | 0.36 pg/ml | Standard Deviation 1.68 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | IL-1a | -0.20 pg/ml | Standard Deviation 0.36 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | IL-5 | 0.34 pg/ml | Standard Deviation 0.46 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | IL-7 | -0.14 pg/ml | Standard Deviation 1.63 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | VEGF-A | -0.05 pg/ml | Standard Deviation 7.98 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | VEGF-C | 2000.38 pg/ml | Standard Deviation 6648.4 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | VEGF-D | 3741.02 pg/ml | Standard Deviation 3124.38 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | Eotaxin | 22.07 pg/ml | Standard Deviation 36.04 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | Eotaxin-3 | -3.60 pg/ml | Standard Deviation 6.19 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | IP-10 | 18.26 pg/ml | Standard Deviation 80.08 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | MCP-1 | -4.80 pg/ml | Standard Deviation 10.74 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | MIP1-α | -0.83 pg/ml | Standard Deviation 3.64 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | sFLT-1 | 258.88 pg/ml | Standard Deviation 237.44 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | PIGF | 20.81 pg/ml | Standard Deviation 11.81 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | sICAM1 | 91844.33 pg/ml | Standard Deviation 1329185.57 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | SAA | 190090000 pg/ml | Standard Deviation 936172849 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | CRP | 36165816.2 pg/ml | Standard Deviation 111516450.7 |
| RAPA Intervention | Change in Plasma Inflammatory Markers From Baseline to 8 Weeks | IFN-γ | 4.37 pg/ml | Standard Deviation 1.91 |
Secondary
Change in Vitals From Baseline to 8 Weeks
Evaluation of vitals. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: Baseline to 8 weeks
Population: paired samples t-test comparing pre to post-treatment blood pressure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RAPA Intervention | Change in Vitals From Baseline to 8 Weeks | systolic blood pressure | 10.45 mmHg | Standard Deviation 7.82 |
| RAPA Intervention | Change in Vitals From Baseline to 8 Weeks | diastolic blood pressure | 1.7 mmHg | Standard Deviation 5.87 |
Secondary
Cognition/Functional Status - Change in Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) assesses global cognition with scores ranging from 0 to 30 points. Higher scores indicate better performance.Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change in Montreal Cognitive Assessment (MoCA) | -1.30 score on a scale | Standard Deviation 2.45 |
Secondary
Cognition/Functional Status - Change on Grip Strength, Dominant Hand
The grip strength, dominant hand assesses grip strength in kilograms. Values begin at 0 with no upper limit. Higher scores indicate better performance Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on Grip Strength, Dominant Hand | 0.30 kilograms | Standard Deviation 2.1 |
Secondary
Cognition/Functional Status - Change on Grip Strength, Non-dominant Hand
The grip strength, non-dominant hand assesses grip strength in kilograms. Values begin at 0 with no upper limit. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on Grip Strength, Non-dominant Hand | -0.25 kilograms | Standard Deviation 3.3 |
Secondary
Cognition/Functional Status - Change on Phonemic Fluency
The Phonemic fluency test assesses speeded word generation to a phonemic cue. Scores begin at 0 with no upper limit. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on Phonemic Fluency | 1.80 score on a scale | Standard Deviation 3.71 |
Secondary
Cognition/Functional Status - Change on Semantic Fluency
The Semantic fluency test assesses speeded word generation to a semantic cue. Scores begin at 0 with no upper limit. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on Semantic Fluency | 1.10 score on a scale | Standard Deviation 4.18 |
Secondary
Cognition/Functional Status - Change on the Benson Figure Copy
The Benson Figure Copy assesses visuoconstructional skills with scores ranging from 0 to 17points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on the Benson Figure Copy | 0.70 score on a scale | Standard Deviation 1.83 |
Secondary
Cognition/Functional Status - Change on the Benson Figure Delayed Recall
The Benson Figure Delayed Recall assesses visual memory with scores ranging from 0 to 17 points. Higher scores indicate better performance.Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on the Benson Figure Delayed Recall | -0.80 score on a scale | Standard Deviation 2.04 |
Secondary
Cognition/Functional Status - Change on the Clinical Rating Scale Global Score
The Clinical Rating Scale Global Score assesses cognition and daily functioning with scores ranging from 0 to 3 points. Higher scores indicate worse cognition and/or functional status.Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on the Clinical Rating Scale Global Score | 0.15 score on a scale | Standard Deviation 0.16 |
Secondary
Cognition/Functional Status - Change on the Clinical Rating Scale Sum of Boxes Score
The Clinical Rating Scale Sum of Boxes assesses cognition and daily functioning with scores ranging from 0 to 18 points. Higher scores indicate worse cognition and/or functional status.Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on the Clinical Rating Scale Sum of Boxes Score | 0.55 score on a scale | Standard Deviation 0.86 |
Secondary
Cognition/Functional Status - Change on the Craft Story Delayed Recall Verbatim
The Craft Story Delayed Recall Verbatim assesses verbal memory recall with scores ranging from 0 to 44 points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on the Craft Story Delayed Recall Verbatim | -1.40 score on a scale | Standard Deviation 2.95 |
Secondary
Cognition/Functional Status - Change on the Craft Story Immediate Recall Verbatim
The Craft Story Immediate Recall Verbatim assesses verbal narrative learning with scores ranging from 0 to 44 points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on the Craft Story Immediate Recall Verbatim | 0.20 score on a scale | Standard Deviation 4.29 |
Secondary
Cognition/Functional Status - Change on the Functional Activities Questionnaire
The Functional Activities Questionnaire assesses functional status for independent activities of daily living. Scores range from 0 to 30 and higher scores indicate worse outcomes. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on the Functional Activities Questionnaire | -0.10 score on a scale | Standard Deviation 4.36 |
Secondary
Cognition/Functional Status - Change on the Geriatric Depression Scale 15-item
The Geriatric Depression Scale 15-item assesses depressive symptomatology. Scores range from 0 to 15 and higher scores indicate worse outcomes. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on the Geriatric Depression Scale 15-item | 0.10 score on a scale | Standard Deviation 1.73 |
Secondary
Cognition/Functional Status - Change on the Hayling, Total Errors
The Hayling assesses response inhibition errors. Scores range from 0 to 30 and higher scores indicate worse performance. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on the Hayling, Total Errors | 0.001 score on a scale | Standard Deviation 0.78 |
Secondary
Cognition/Functional Status - Change on the Hopkins Verbal Learning Test - Revised Delayed Recall
The Hopkins Verbal Learning Test - Revised Delayed Recall assesses verbal list learning with scores ranging from 0 to 12 points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on the Hopkins Verbal Learning Test - Revised Delayed Recall | -1.00 score on a scale | Standard Deviation 2.54 |
Secondary
Cognition/Functional Status - Change on the Hopkins Verbal Learning Test - Revised Immediate Recall
The Hopkins Verbal Learning Test - Revised Immediate Recall assesses verbal list learning with scores ranging from 0 to 36 points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on the Hopkins Verbal Learning Test - Revised Immediate Recall | 0.40 score on a scale | Standard Deviation 3.37 |
Secondary
Cognition/Functional Status - Change on the Multilingual Naming Test
The Multilingual Naming Test assesses confrontation naming. Scores range from 0 to 32 and higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on the Multilingual Naming Test | 1.50 score on a scale | Standard Deviation 4.67 |
Secondary
Cognition/Functional Status - Change on the Neuropsychiatric Inventory Questionnaire
The Neuropsychiatric Inventory Questionnaire assesses neuropsychiatric symptoms. Scores range from 0 to 12 and higher scores indicate worse outcomes. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on the Neuropsychiatric Inventory Questionnaire | 0.70 score on a scale | Standard Deviation 2.83 |
Secondary
Cognition/Functional Status - Change on the Number Span Backward
The Number Span Backward test assesses working memory with scores ranging from 0 to 14 points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on the Number Span Backward | -0.60 score on a scale | Standard Deviation 0.84 |
Secondary
Cognition/Functional Status - Change on the Number Span Forward
The Number Span Forward test assesses basic attention with scores ranging from 0 to 16 points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on the Number Span Forward | 0.20 score on a scale | Standard Deviation 1.62 |
Secondary
Cognition/Functional Status - Change on the Trail Making Test Part A, Time to Completion
The Trail Making Test Part A, time to completion assesses psychomotor speed and visual scanning with scores ranging from 1 to 150 seconds. Higher scores indicate worse performance. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change on the Trail Making Test Part A, Time to Completion | 3.09 seconds to complete | Standard Deviation 3.15 |
Secondary
Cognition/Functional Status - Change Trail Making Test Part B, Time to Completion
The Trail Making Test Part B, time to completion assesses attentional shifting with scores ranging from 1 to 300 seconds. Higher scores indicate worse performance. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Cognition/Functional Status - Change Trail Making Test Part B, Time to Completion | 26.69 seconds to complete | Standard Deviation 14.97 |
Secondary
Percentage of Study Drug Pills Taken
Average percentage of study drug pills taken across all 10 subjects after they were enrolled and randomized to treatment. The percentage of study drug pills taken was evaluated by having participants return any leftover study drug pills at each visit during the active treatment period.
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Percentage of Study Drug Pills Taken | 92 percentage of study drug pills taken | Standard Deviation 5 |
Secondary
Safety Labs - Change in Hematocrit
Evaluation of of safety labs - hematocrit. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Safety Labs - Change in Hematocrit | -0.86 percentage of red blood cells | Standard Deviation 2.09 |
Secondary
Safety Labs - Change in Hemoglobin A1c
Evaluation of of safety labs - hemoglobin A1c. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Safety Labs - Change in Hemoglobin A1c | 0.17 % of hemoglobin covered w/ glucose | Standard Deviation 0.22 |
Secondary
Safety Labs - Change in Liver Panel (iU/L)
Evaluation of safety labs - liver panel. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RAPA Intervention | Safety Labs - Change in Liver Panel (iU/L) | Aspartate Aminotransferase | 1.00 IU/L | Standard Deviation 4.06 |
| RAPA Intervention | Safety Labs - Change in Liver Panel (iU/L) | Alanine Transaminase | 0.001 IU/L | Standard Deviation 6.2 |
| RAPA Intervention | Safety Labs - Change in Liver Panel (iU/L) | Alkaline Phosphatase | 4.10 IU/L | Standard Deviation 10.9 |
Secondary
Safety Labs - Change in Mean Corpuscular Hemoglobin
safety labs - Mean Corpuscular Hemoglobin. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Safety Labs - Change in Mean Corpuscular Hemoglobin | -0.81 pg | Standard Deviation 0.69 |
Secondary
Safety Labs - Change in Mean Corpuscular Volume
Evaluation of safety labs - Change in Mean Corpuscular volume. Change is calculated as value at 8 weeks minus the value at baseline
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Safety Labs - Change in Mean Corpuscular Volume | -2.70 fL | Standard Deviation 2.16 |
Secondary
Safety Labs - Change in Metabolic and Lipid Parameters (mg/dl)
Evaluation of safety labs - metabolic and lipid parameters. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RAPA Intervention | Safety Labs - Change in Metabolic and Lipid Parameters (mg/dl) | glucose | 2.70 mg/dl | Standard Deviation 6.67 |
| RAPA Intervention | Safety Labs - Change in Metabolic and Lipid Parameters (mg/dl) | Creatinine | -0.001 mg/dl | Standard Deviation 0.09 |
| RAPA Intervention | Safety Labs - Change in Metabolic and Lipid Parameters (mg/dl) | Bilirubin | -0.09 mg/dl | Standard Deviation 0.34 |
| RAPA Intervention | Safety Labs - Change in Metabolic and Lipid Parameters (mg/dl) | Cholesterol | -0.30 mg/dl | Standard Deviation 26.08 |
| RAPA Intervention | Safety Labs - Change in Metabolic and Lipid Parameters (mg/dl) | blood urea nitrogen | -1.80 mg/dl | Standard Deviation 4.13 |
| RAPA Intervention | Safety Labs - Change in Metabolic and Lipid Parameters (mg/dl) | High-Density Lipoprotein Cholesterol | 2.90 mg/dl | Standard Deviation 7.22 |
| RAPA Intervention | Safety Labs - Change in Metabolic and Lipid Parameters (mg/dl) | Low-Density Lipoprotein Cholesterol | -2.70 mg/dl | Standard Deviation 20.38 |
| RAPA Intervention | Safety Labs - Change in Metabolic and Lipid Parameters (mg/dl) | Very Low-Density Lipoprotein Cholesterol | -0.50 mg/dl | Standard Deviation 4.25 |
Secondary
Safety Labs - Change in Metabolic Parameters (g/dl)
Evaluation of safety labs - metabolic parameters. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RAPA Intervention | Safety Labs - Change in Metabolic Parameters (g/dl) | Hemoglobin | -0.27 g/dl | Standard Deviation 0.57 |
| RAPA Intervention | Safety Labs - Change in Metabolic Parameters (g/dl) | Protein | -1.77 g/dl | Standard Deviation 5.85 |
| RAPA Intervention | Safety Labs - Change in Metabolic Parameters (g/dl) | Albumin | -0.13 g/dl | Standard Deviation 0.19 |
| RAPA Intervention | Safety Labs - Change in Metabolic Parameters (g/dl) | Mean Corpuscular Hemoglobin Concentration | 0.08 g/dl | Standard Deviation 0.85 |
Secondary
Safety Labs - Change in Monocytes
Evaluation of of safety labs - monocytes. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Safety Labs - Change in Monocytes | -0.19 percentage of white blood cell count | Standard Deviation 4.08 |
Secondary
Safety Labs - Change in Red Blood Cell Count
Evaluation of safety labs - red blood cell counts. Change in red blood cell count calculated as value at 8 weeks minus the value at baseline.
Time frame: Baseline to 8 weeks
Population: paired sample's t-test comparing pre to post-treatment safety laboratory values
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Safety Labs - Change in Red Blood Cell Count | -0.01 x10^6 cells/μL | Standard Deviation 0.27 |
Secondary
Safety Labs - Change in Red Cell Distribution Width
Evaluation of of safety labs - Red cell distribution width. Change is calculated as value at 8 weeks minus the value at baseline. The value reported is % of red blood cell size and volume variability.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAPA Intervention | Safety Labs - Change in Red Cell Distribution Width | -0.65 Percentage | Standard Deviation 0.24 |
Secondary
Safety Labs - Change in Sodium and Potassium (mmol/L)
Evaluation of safety labs - sodium and potassium. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RAPA Intervention | Safety Labs - Change in Sodium and Potassium (mmol/L) | Potassium | -0.19 mmol/L | Standard Deviation 0.44 |
| RAPA Intervention | Safety Labs - Change in Sodium and Potassium (mmol/L) | Sodium | -5.40 mmol/L | Standard Deviation 18.9 |
Secondary
Safety Labs - Change in White Blood Cell and Platelet Counts From Baseline to 8 Weeks
Evaluation of safety labs - white blood cell and platelet counts. Change is calculated as value at 8 weeks minus the value at baseline.
Time frame: Baseline to 8 weeks
Population: paired samples t-test comparing pre to post-treatment safety laboratory values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RAPA Intervention | Safety Labs - Change in White Blood Cell and Platelet Counts From Baseline to 8 Weeks | White Blood Cell Count | 0.42 x10^3 cells/μL | Standard Deviation 1.92 |
| RAPA Intervention | Safety Labs - Change in White Blood Cell and Platelet Counts From Baseline to 8 Weeks | Immature Granulocytes | -0.21 x10^3 cells/μL | Standard Deviation 1.19 |
| RAPA Intervention | Safety Labs - Change in White Blood Cell and Platelet Counts From Baseline to 8 Weeks | Eosinophils | 0.10 x10^3 cells/μL | Standard Deviation 2.5 |
| RAPA Intervention | Safety Labs - Change in White Blood Cell and Platelet Counts From Baseline to 8 Weeks | Basophils | -0.19 x10^3 cells/μL | Standard Deviation 0.4 |
| RAPA Intervention | Safety Labs - Change in White Blood Cell and Platelet Counts From Baseline to 8 Weeks | Platelets | 20.60 x10^3 cells/μL | Standard Deviation 35.19 |