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Inflammation plays a central role in Parkinson's disease. The use of anti-inflammatory drugs was found to reduce the risk of PD . Niacin may play an important role in reducing inflammation in PD. The investigators also found that individuals with PD have a chronic niacin deficiency .
The purposes of this study are to (1) examine the blood, urine and spinal fluid of persons with Parkinson's to look for evidence of inflammation and; (2) whether 6 months of vitamin B3 supplements may reduce the inflammation and/or improve symptoms.
Inflammation plays a central role in Parkinson's disease (PD) pathology [1] as evidenced by the presence of microglia in the substantia nigra in post-mortem samples [2] as well as activated microglia and cytokines in clinical and animal studies [3]. The use of non-aspirin non-steroidal anti-inflammatory drugs was found to reduce the risk of PD [4]. The investigators recently identified an anti-inflammatory receptor GPR109A that is upregulated in PD [5]. Niacin has a high affinity for this receptor, suggesting that it (niacin) may play an important role in reducing inflammation in PD. The investigators also found that individuals with PD have a chronic niacin deficiency [5]. Using seed funding from the local PD chapter, the investigators obtained pilot data which suggested that restoring the deficiency via over-the-counter (OTC) supplementation reduced inflammation and decreased the severity of the disease symptoms [6]. In this VA-funded study, the investigators will determine the effect of 6 months' OTC niacin supplementation on inflammation (as assessed in the blood and spinal fluid) and severity of the PD symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| niacin | Active Comparator | Niacin 250 mg is compared to placebo tablet. |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| niacin | Dietary Supplement | Niacin or nicotinic acid 250 mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) Change | This is the Unified Parkinson's disease rating scale assessment. The investigators assess I, II, III and V components of the UPDRS. UPDRS 3 is motor skills. Higher scores mean worse outcome. A 0 is minimum and 120 is the maximum. | at the recruitment and after 6 months |
| REM Sleep Pattern | This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the rapid eye movement (REM) sleep as a percentage. | baseline and after 6 months |
| Deep Sleep | This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the deep sleep percentage. | At baseline and after 6 months |
| Light Sleep | This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the light sleep percentage. | baseline and 6 months |
| Sleep Time - Awake | This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the awake time during night sleep percentage. | at baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebrospinal Fluid Changes - Interleukin 6 (IL6) | IL-6 cytokine levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. | at baseline and after 6 months |
| Cerebrospinal Fluid Changes - Interleukin 10 (IL-10) |
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Inclusion Criteria:
PD subjects will be adult men and women diagnosed with idiopathic mild to moderately severe PD defined as modified Hoehn & Yahr Stages I-III (while "On").
Subjects should be stabilized on PD medication for at least 3 months before enrollment into the study.
Subjects' PD drug prescriptions will not be altered nor withheld during the study, i.e., they will be tested while "On."
The patient will have signed informed consent.
Subjects who do not have PD (i.e., healthy or have other medical conditions such as traumatic brain injury (TBI), stroke, or other syndromes in which inflammation plays a role in the condition) will also be recruited as control subjects.
This will allow us to estimate whether these other conditions show similar or unique inflammatory profile.
Exclusion Criteria:
Subjects will be excluded if they had previous brain surgery or other severe neurological problems
All subjects must be without evidence of dementia, defined as a score > 24 the Mini-Mental State Examination and able to understand test instructions
Subjects must not have functional blindness (inability to participate in gait and visuomotor assessments) or lower limb amputation higher than the forefoot or any orthopedic problem that precludes performance of physical tests
Allergic to niacin
Significant cardiac, pulmonary, hepatic, gastrointestinal, or renal disease
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| Name | Affiliation | Role |
|---|---|---|
| Chandramohan Wakade, MBBS | Charlie Norwood VA Medical Center, Augusta, GA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charlie Norwood VA Medical Center, Augusta, GA | Augusta | Georgia | 30904 | United States |
As the investigators request, we will share the data.
One year after the study is closed.
When we are ready to publish, the data will be available.
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| ID | Title | Description |
|---|---|---|
| FG000 | Niacin | Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets |
| FG001 | Placebo | placebo placebo: placebo tablet |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Niacin | Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets |
| BG001 | Placebo | placebo placebo: placebo tablet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Unified Parkinson's Disease Rating Scale (UPDRS) Change | This is the Unified Parkinson's disease rating scale assessment. The investigators assess I, II, III and V components of the UPDRS. UPDRS 3 is motor skills. Higher scores mean worse outcome. A 0 is minimum and 120 is the maximum. | Patients who completed 6 months were analyzed for this measure (39 subjects). | Posted | Mean | Standard Deviation | units on a scale | at the recruitment and after 6 months |
|
6 months
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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 | Niacin | Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| flushing | Blood and lymphatic system disorders | Non-systematic Assessment | minimal flushing on either face or trunk |
Additional studies are required including a larger cohort and multi-center to further generalize findings, as well as comparing niacin to placebo for longer than 6 months before optimal information can be obtained for use in clinical settings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chandramohan Wakade | Charlie Norwood VAMC | 706-733-0188 | 2379 | chandramohan.wakade@va.gov |
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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 24, 2016 | Jul 19, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 21, 2020 | Nov 18, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D009525 | Niacin |
| D009536 | Niacinamide |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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There are two arms, niacin and placebo. They are double blind and randomized.
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Only Pharmacists keep the log of the drug dispensed. Everyone else is blinded.
| placebo | Other | placebo tablet |
|
| Mini-Mental State Examination (MMSE) Change | It captures mental status and awareness of time, place and surrounding. A zero is minimum and 30 is maximum. Higher score indicates better cognition. | at baseline and after 6 months of treatment |
| Stroop Test Change | It captures understanding of color and its description within a certain time frame when letters and colors do not match. There are only two choices to pick from and the correct choices should be made to proceed to the next one. Correct choices are given one point and incorrect choices delete one point. Maximum number of correct choices per unit time are recorded. Three initial trials are given to understand the test. No minimum or maximum values. Higher numbers indicate better cognition. | at the baseline and after 6 months of intervention |
| Fatigue Severity Scale | Fatigue was rated from 0-7 in a fatigue questionnaire. A 0 being the least and 7 being the highest level of fatigue. | at baseline and after 6 months |
IL-10 will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention.
| at baseline and after 6 months |
| Niacin Metabolite in Urine - Niacin | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels | at baseline and after 6 months |
| Niacin Metabolites in Urine - NAM Nicotinamide | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels | at baseline and 6 months |
| Niacin Changes in Plasma - Niacin | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels. | baseline and 6 months |
| Niacin Changes in Plasma - NUA Nicotinuric Acid | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels | at baseline and 6 months |
| Cerebrospinal Fluid Changes - Interleukin 8 (IL8) | IL-8 cytokine levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. | at baseline and after 6 months |
| Niacin Metabolite in Urine - Nicotinuric Acid NUA | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels | at baseline and after 6 months |
| CSF Fluid Changes - Interleukin 1B (IL-1B) | IL-1beta levels were tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. | at baseline and 6 months |
| Cerebrospinal Fluid (CSF) Changes - Macrophage Inflammatory Protein 1 Beta (MIP 1 Beta) | Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of MIP-1 beta here. | at baseline and after 6 months |
| Macrophage Changes | The blood is tested to report G-protein coupled receptor 109A (GPR109A) levels in macrophages in M1 and M2 populations. | at baseline and after 6 months |
| Niacin Metabolite Changes in Plasma - Nicotinamide (NAM) | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels. | at baseline and after 6 months |
| CSF Changes in Interferon Gamma (IF-gamma) | Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of IF-gamma beta here. | at baseline and after 6 months |
| CSF Changes - Tumor Necrosis Factor - Alpha (TNF-alpha) | Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of TNF-alpha here. | at baseline and after 6 months |
| Cerebral Spinal Fluid Changes - Interferon Gamma Induced Protein -10 (IP-10) | Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of IP-10 here. | at baseline and after 6 months |
| Cerebral Spinal Fluid (CSF) Changes - Monocyte Chemoattractant Protein 4 (MCP4) | Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of MCP4 here. | at baseline and after 6 months |
| Cerebral Spinal Fluid (CSF) Changes - MIP1-alpha | Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of MIP1-alpha here. | at baseline and after 6 months |
| Plasma Cytokines - IF Gamma | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IF-gamma here. | at baseline and after 6 months |
| Plasma Cytokines - IL-10 | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-10 here. | at baseline and after 6 months |
| Plasma Cytokines - IL1-B | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-1B here. | at baseline and after 6 months |
| Plasma Cytokines - IL-6 | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-6 here. | at baseline and after 6 months |
| Plasma Cytokines - IL-8 | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-8 here. | at baseline and after 6 Months |
| Plasma Cytokines - TNF-alpha | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of TNF-alpha here. | at baseline and after 6 months |
| Plasma Cytokines - IP-10 | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IP-10 here. | at baseline and after 6 months |
| Plasma Cytokines - MCP-4 | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of MCP-4 here. | at baseline and after 6 months |
| Plasma Cytokines - MIP1-alpha | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of MIP1-alpha here. | at baseline and after 6 months |
| Plasma Cytokines - MIP1-beta | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of MIP1-beta here. | at baseline and after 6 months |
| Plasma Levels - Serotonin | Plasma serotonin levels | at baseline and after 6 months |
| BG002 | Total | Total of all reporting groups |
| 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 | Count of Participants | Participants |
|
| UPDRS III | The minimum is 0 and the maximum is 120. Higher scores are worse outcomes. | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | REM Sleep Pattern | This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the rapid eye movement (REM) sleep as a percentage. | Patients who completed 6 months were analyzed for this measure (39 subjects). | Posted | Mean | Standard Deviation | percentage of sleep time | baseline and after 6 months |
|
|
|
| Primary | Deep Sleep | This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the deep sleep percentage. | Patients who completed 6 months were analyzed for this measure (39 subjects). | Posted | Mean | Standard Deviation | percentage of deep sleep time | At baseline and after 6 months |
|
|
|
| Primary | Light Sleep | This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the light sleep percentage. | Patients who completed 6 months were analyzed for this measure (39 subjects). | Posted | Mean | Standard Deviation | percentage of light sleep time | baseline and 6 months |
|
|
|
| Primary | Sleep Time - Awake | This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the awake time during night sleep percentage. | Patients who completed 6 months were analyzed for this measure (39 subjects). | Posted | Mean | Standard Deviation | percentage of awake-sleep time | at baseline and 6 months |
|
|
|
| Primary | Mini-Mental State Examination (MMSE) Change | It captures mental status and awareness of time, place and surrounding. A zero is minimum and 30 is maximum. Higher score indicates better cognition. | Patients who completed 6 months were analyzed for this measure (39 subjects). | Posted | Mean | Standard Deviation | score on a scale | at baseline and after 6 months of treatment |
|
|
|
| Primary | Stroop Test Change | It captures understanding of color and its description within a certain time frame when letters and colors do not match. There are only two choices to pick from and the correct choices should be made to proceed to the next one. Correct choices are given one point and incorrect choices delete one point. Maximum number of correct choices per unit time are recorded. Three initial trials are given to understand the test. No minimum or maximum values. Higher numbers indicate better cognition. | Stroop test was added after recruitment of few subjects. | Posted | Mean | Standard Deviation | number of correct responses/unit time | at the baseline and after 6 months of intervention |
|
|
|
| Primary | Fatigue Severity Scale | Fatigue was rated from 0-7 in a fatigue questionnaire. A 0 being the least and 7 being the highest level of fatigue. | Patients who completed 6 months were analyzed for this measure (39 subjects). | Posted | Mean | Standard Deviation | score on a scale | at baseline and after 6 months |
|
|
|
| Secondary | Cerebrospinal Fluid Changes - Interleukin 6 (IL6) | IL-6 cytokine levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. | Not all subjects donated CSF. All CSF samples are recorded here. | Posted | Mean | Standard Deviation | pg/ml | at baseline and after 6 months |
|
|
|
| Secondary | Cerebrospinal Fluid Changes - Interleukin 10 (IL-10) | IL-10 will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. | Not all subjects donated CSF. All CSF samples are recorded here. | Posted | Mean | Standard Deviation | pg/ml | at baseline and after 6 months |
|
|
|
| Secondary | Niacin Metabolite in Urine - Niacin | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels | A subset of groups were analyzed. | Posted | Mean | Standard Deviation | ng/L | at baseline and after 6 months |
|
|
|
| Secondary | Niacin Metabolites in Urine - NAM Nicotinamide | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels | A subset of subjects were randomly selected for this analysis. | Posted | Mean | Standard Deviation | ng/L | at baseline and 6 months |
|
|
|
| Secondary | Niacin Changes in Plasma - Niacin | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels. | A subset of subjects were randomly selected for this analysis. | Posted | Mean | Standard Deviation | nM/L | baseline and 6 months |
|
|
|
| Secondary | Niacin Changes in Plasma - NUA Nicotinuric Acid | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels. Undetectable values are reported as zero. A subset of the groups were analyzed. | Posted | Mean | Standard Deviation | nM/L | at baseline and 6 months |
|
|
|
| Secondary | Cerebrospinal Fluid Changes - Interleukin 8 (IL8) | IL-8 cytokine levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. | Not all subjects donated CSF. All CSF samples are recorded here. | Posted | Mean | Standard Deviation | pg/ml | at baseline and after 6 months |
|
|
|
| Secondary | Niacin Metabolite in Urine - Nicotinuric Acid NUA | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels. A subset of the groups were analyzed. | Posted | Mean | Standard Deviation | ng/L | at baseline and after 6 months |
|
|
|
| Secondary | CSF Fluid Changes - Interleukin 1B (IL-1B) | IL-1beta levels were tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. | Not all subjects donated CSF. All CSF samples are recorded here. | Posted | Mean | Standard Deviation | pg/ml | at baseline and 6 months |
|
|
|
| Secondary | Cerebrospinal Fluid (CSF) Changes - Macrophage Inflammatory Protein 1 Beta (MIP 1 Beta) | Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of MIP-1 beta here. | Not all subjects donated CSF. All CSF samples are recorded here. | Posted | Mean | Standard Deviation | pico grams per ml | at baseline and after 6 months |
|
|
|
| Secondary | Macrophage Changes | The blood is tested to report G-protein coupled receptor 109A (GPR109A) levels in macrophages in M1 and M2 populations. | A subset of subjects were randomly selected for this measure and all the data is recorded here that was captured. | Posted | Mean | Standard Deviation | percentage of macrophages | at baseline and after 6 months |
|
|
|
| Secondary | Niacin Metabolite Changes in Plasma - Nicotinamide (NAM) | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels. | A subset of subjects were randomly selected for this analysis. | Posted | Mean | Standard Deviation | uM/L | at baseline and after 6 months |
|
|
|
| Secondary | CSF Changes in Interferon Gamma (IF-gamma) | Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of IF-gamma beta here. | Posted | Mean | Standard Deviation | pg/ml | at baseline and after 6 months |
|
|
|
| Secondary | CSF Changes - Tumor Necrosis Factor - Alpha (TNF-alpha) | Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of TNF-alpha here. | Posted | Mean | Standard Deviation | pg/ml | at baseline and after 6 months |
|
|
|
| Secondary | Cerebral Spinal Fluid Changes - Interferon Gamma Induced Protein -10 (IP-10) | Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of IP-10 here. | Posted | Mean | Standard Deviation | pg/ml | at baseline and after 6 months |
|
|
|
| Secondary | Cerebral Spinal Fluid (CSF) Changes - Monocyte Chemoattractant Protein 4 (MCP4) | Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of MCP4 here. | Not all subjects donated CSF. All CSF samples are recorded here. | Posted | Mean | Standard Deviation | pg/ml | at baseline and after 6 months |
|
|
|
| Secondary | Cerebral Spinal Fluid (CSF) Changes - MIP1-alpha | Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of MIP1-alpha here. | Posted | Mean | Standard Deviation | pg/ml | at baseline and after 6 months |
|
|
|
| Secondary | Plasma Cytokines - IF Gamma | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IF-gamma here. | Posted | Mean | Standard Deviation | pg/ml | at baseline and after 6 months |
|
|
|
| Secondary | Plasma Cytokines - IL-10 | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-10 here. | Posted | Mean | Standard Deviation | pg/ml | at baseline and after 6 months |
|
|
|
| Secondary | Plasma Cytokines - IL1-B | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-1B here. | Posted | Mean | Standard Deviation | pg/ml | at baseline and after 6 months |
|
|
|
| Secondary | Plasma Cytokines - IL-6 | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-6 here. | Posted | Mean | Standard Deviation | pg/ml | at baseline and after 6 months |
|
|
|
| Secondary | Plasma Cytokines - IL-8 | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-8 here. | Posted | Mean | Standard Deviation | pg/ml | at baseline and after 6 Months |
|
|
|
| Secondary | Plasma Cytokines - TNF-alpha | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of TNF-alpha here. | Posted | Mean | Standard Deviation | pg/ml | at baseline and after 6 months |
|
|
|
| Secondary | Plasma Cytokines - IP-10 | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IP-10 here. | Posted | Mean | Standard Deviation | pg/ml | at baseline and after 6 months |
|
|
|
| Secondary | Plasma Cytokines - MCP-4 | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of MCP-4 here. | Posted | Mean | Standard Deviation | pg/ml | at baseline and after 6 months |
|
|
|
| Secondary | Plasma Cytokines - MIP1-alpha | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of MIP1-alpha here. | Posted | Mean | Standard Deviation | pg/ml | at baseline and after 6 months |
|
|
|
| Secondary | Plasma Cytokines - MIP1-beta | Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of MIP1-beta here. | Posted | Mean | Standard Deviation | pg/ml | at baseline and after 6 months |
|
|
|
| Secondary | Plasma Levels - Serotonin | Plasma serotonin levels | a subset of the groups were analyzed. | Posted | Mean | Standard Deviation | mg/dL | at baseline and after 6 months |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 7 |
| 21 |
| EG001 | Placebo | placebo placebo: placebo tablet | 0 | 26 | 0 | 26 | 0 | 26 |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |