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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR002645 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAPA intervention | Experimental | Sirolimus 1mg orally once a day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapamune | Drug | Sirolimus 1mg capsules |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of adverse events experienced across all 10 subjects after they were enrolled and randomized to treatment, regardless of relatedness to intervention. | Baseline to 8 weeks |
| Change in Vitals From Baseline to 8 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitzi Gonzales, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTHSA McDermott Clinical Sciences Building | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40394335 | Derived | Gonzales MM, Garbarino VR, Kautz TF, Song X, Lopez-Cruzan M, Linehan L, Van Skike CE, De Erausquin GA, Galvan V, Orr ME, Musi N, He Y, Bateman RJ, Wang CP, Seshadri S, Kraig E, Kellogg D Jr. Rapamycin treatment for Alzheimer's disease and related dementias: a pilot phase 1 clinical trial. Commun Med (Lond). 2025 May 20;5(1):189. doi: 10.1038/s43856-025-00904-9. |
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The Institution, Sponsor or respective designees may review results prior to presenting or publishing the results of a scientific investigation involving this Study in accordance with ICJME guidelines and institutional requirements.
After publication in a peer reviewed journal
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Subjects that were enrolled and passed eligibility screening and went on to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | RAPA Intervention | Sirolimus 1mg orally once a day for 8 weeks Rapamune: Sirolimus 1mg capsules |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RAPA Intervention | Sirolimus 1mg orally once a day for 8 weeks Rapamune: Sirolimus 1mg capsules |
| 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 | 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. | HPLC/MS/MS | Posted | Mean | Standard Deviation | ng/ml | Change from Baseline to 8 weeks |
|
|
8 weeks
All adverse events that occurred after enrollment and randomization are reported, whether considered not related to or possible related to intervention.
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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 | RAPA Intervention | Sirolimus 1mg orally once a day for 8 weeks Rapamune: Sirolimus 1mg capsules |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Altered Mental Status | Nervous system disorders | Non-systematic Assessment | Unrelated to study intervention, possible TIA |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intermittent Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Mild and unlikely to be related to intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mitzi Gonzales, PhD | UT Health San Antonio | 210-450-9047 | Gonzalesm20@uthscsa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 18, 2021 | Jan 27, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 18, 2021 | Jan 27, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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Evaluation of vitals. Change is calculated as value at 8 weeks minus the value at baseline.
| Baseline to 8 weeks |
| 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. | Baseline to 8 weeks |
| 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. | Baseline to 8 weeks |
| 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. | Baseline to 8 weeks |
| 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. | Baseline to 8 weeks |
| 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. | Baseline to 8 weeks |
| 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. | Baseline to 8 weeks |
| 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. | Baseline to 8 weeks |
| 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 | 8 weeks |
| 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. | 8-weeks |
| 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. | 8 weeks |
| Safety Labs - Change in Hematocrit | Evaluation of of safety labs - hematocrit. Change is calculated as value at 8 weeks minus the value at baseline. | 8 weeks |
| Safety Labs - Change in Monocytes | Evaluation of of safety labs - monocytes. Change is calculated as value at 8 weeks minus the value at baseline. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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 |
|
| Diagnosis | Clinical diagnosis of mild cognitive impairment or early-stage Alzheimer's disease by a qualified physician | Count of Participants | Participants |
|
|
| 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. | Posted | Number | Events | Baseline to 8 weeks |
|
|
|
| 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. | paired samples t-test comparing pre to post-treatment blood pressure. | Posted | Mean | Standard Deviation | mmHg | Baseline to 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage of study drug pills taken | Baseline to 8 weeks |
|
|
|
| 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. | paired samples t-test comparing pre to post-treatment CSF ADRD biomarker levels | Posted | Mean | Standard Deviation | ng/ml | Baseline to 8 weeks |
|
|
|
| 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. | paired samples t-test comparing pre to post-treatment plasma ADRD biomarker levels | Posted | Mean | Standard Deviation | ng/ml | Baseline to 8 weeks |
|
|
|
| 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. | paired samples t-test comparing pre to post-treatment CSF inflammatory values. | Posted | Mean | Standard Deviation | pg/ml | Baseline to 8 weeks |
|
|
|
| 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. | paired samples t-test comparing pre to post-treatment plasma inflammatory biomarkers. | Posted | Mean | Standard Deviation | pg/ml | Baseline to 8 weeks |
|
|
|
| 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. | paired samples t-test comparing pre to post-treatment safety laboratory values. | Posted | Mean | Standard Deviation | x10^3 cells/μL | Baseline to 8 weeks |
|
|
|
| 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. | paired sample's t-test comparing pre to post-treatment safety laboratory values | Posted | Mean | Standard Deviation | x10^6 cells/μL | Baseline to 8 weeks |
|
|
|
| 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 | Posted | Mean | Standard Deviation | fL | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | pg | 8-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | g/dl | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage of red blood cells | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage of white blood cell count | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Percentage | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | % of hemoglobin covered w/ glucose | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mg/dl | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mmol/L | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | IU/L | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | seconds to complete | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | seconds to complete | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | kilograms | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | kilograms | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| 10 |
| 10 |
|
|
| Headache | Nervous system disorders | Non-systematic Assessment | Moderate and not related to intervention |
|
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment | Mild and unlikely related to intervention |
|
| Hyperkalemia | Blood and lymphatic system disorders | Non-systematic Assessment | Mild and unlikely to be related to intervention |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Mild and unlikely to be related to intervention for one subject, possible for the other |
|
| Skin infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Not related to intervention (kitten scratches) |
|
| Leg edema | Blood and lymphatic system disorders | Non-systematic Assessment | Mild for one subject, moderate for the other and unlikely to be related to intervention |
|
| Emesis | Gastrointestinal disorders | Non-systematic Assessment | Mild, unlikely to have been related to study intervention |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Mild and not likely to be related to intervention |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment | Mild, one subject was possibly related, the other was not |
|
| Urinary incontinence | Renal and urinary disorders | Non-systematic Assessment | Mild and unlikely related |
|
| Urinary urgency | Renal and urinary disorders | Non-systematic Assessment | Mild and unlikely related |
|
| Fall | General disorders | Non-systematic Assessment | Mild and unlikely related |
|
Not provided
Not provided
Not provided
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| Title |
|---|
| Measurements |
|---|
|
| CSF GFAP |
|
| CSF NFL |
|
| Title | Measurements |
|---|
|
| Plasma GFAP |
|
| Plasma NFL |
|
| Title |
|---|
| Measurements |
|---|
|
| TNF-α |
|
| IL-12 |
|
| IL-15 |
|
| IL-16 |
|
| IL-17a |
|
| IL-1a |
|
| IL-5 |
|
| IL-7 |
|
| VEGF-A |
|
| VEGF-C |
|
| VEGF-D |
|
| Eotaxin |
|
| Eotaxin-3 |
|
| IP-10 |
|
| MCP-1 |
|
| MIP1-α |
|
| sFLT-1 |
|
| PIGF |
|
| bFGF |
|
| sVCAM1 |
|
| sICAM1 |
|
| SAA |
|
| CRP |
|
| IFN-γ |
|
| Title | Measurements |
|---|
|
| TNF-α |
|
| IL-12 |
|
| IL-15 |
|
| IL-16 |
|
| IL-17a |
|
| IL-1a |
|
| IL-5 |
|
| IL-7 |
|
| VEGF-A |
|
| VEGF-C |
|
| VEGF-D |
|
| Eotaxin |
|
| Eotaxin-3 |
|
| IP-10 |
|
| MCP-1 |
|
| MIP1-α |
|
| sFLT-1 |
|
| PIGF |
|
| bFGF |
|
| sVCAM1 |
|
| sICAM1 |
|
| SAA |
|
| CRP |
|
| IFN-γ |
|
| Title | Measurements |
|---|---|
|
| Basophils |
|
| Platelets |
|
|
| Mean Corpuscular Hemoglobin Concentration |
|
|
| Bilirubin |
|
| Cholesterol |
|
| High-Density Lipoprotein Cholesterol |
|
| Low-Density Lipoprotein Cholesterol |
|
| Very Low-Density Lipoprotein Cholesterol |
|
|