Parkinson's DiseaseNCT03462680
GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures
A study testing niacin in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- niacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2016to 23 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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").
- PD is defined according to the United Kingdom Brain Bank Criteria made at least six months prior to recruitment to the study.
- PD features include the presence of at least two of the four cardinal clinical manifestations of the disease, which are tremor, rigidity, bradykinesia, and disturbances of posture or gait, without any other known or suspected cause of Parkinsonism.
- 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.
Who cannot join
- Subjects will be excluded if they had previous brain surgery or other severe neurological problems
- intracerebral hemorrhage
- traumatic brain injury
- central nervous system malignancy
- active central nervous system (CNS) infection
- significant stroke
Show all 17Show fewer
- Alzheimer disease or any type of implanted stimulator including but not limited to Deep Brain Stimulator (DBS) or pacemaker
- 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
- e.g., New York Heart Association Class III or IV congestive heart failure
- endocarditis
- pulmonary insufficiency symptomatic at rest or with mild physical exertion
- acute or chronic hepatitis
- renal failure requiring dialysis
- second and third degree atrioventricular block or sick sinus syndrome), or diabetes are also exclusionary factors
Trial locations and contacts
1 site in 1 country.
United States1 site
Charlie Norwood VA Medical Center, Augusta, GA
Augusta, Georgia, 30904
About this study
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.
Read the detailed description
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.
- Conditions
- Parkinson's Disease
- Being tested
- niacin, placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
niacinDietary supplement
Also called vitamin B3
Niacin or nicotinic acid 250 mg tablets
placeboOther
placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| niacin | Active comparator | Niacin 250 mg is compared to placebo tablet. Receives: Dietary Supplement: niacin |
| placebo | Placebo comparator | placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at baseline and 6 months
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.
Measured: 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.
Measured: 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.
Measured: at baseline and after 6 months
Secondary outcomes (28)
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.
Measured: at baseline and after 6 months
Cerebrospinal Fluid Changes - Interleukin 10 (IL-10)
IL-10 will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at baseline and after 6 months
Plasma Levels - Serotonin
Plasma serotonin levels
Measured: at baseline and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start28 Sep 2016
- Primary completion23 Apr 2020
- Study completion23 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two arms, niacin and placebo. They are double blind and randomized.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Chandramohan Wakade, MBBS, Principal investigator, Charlie Norwood VA Medical Center, Augusta, GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462680
- Sponsor's protocol ID
- N1613-I
- Status last verified
- Oct 2021
- First submitted
- 22 Feb 2018
- Last updated
- 17 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As the investigators request, we will share the data.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures
- ClinicalTrials.gov ID
- NCT03462680
- Acronym / sponsor ID
- N1613-I
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 28 Sep 2016 (actual)
- Primary completion
- 23 Apr 2020 (actual)
- Study completion
- 23 Apr 2020 (actual)
- First posted
- 12 Mar 2018 (actual)
- Results
- Posted 17 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- There are two arms, niacin and placebo. They are double blind and randomized.
| Arm | Type | Receives |
|---|---|---|
| niacin | Active comparator | Dietary Supplement: niacinNiacin 250 mg is compared to placebo tablet. |
| placebo | Placebo comparator | Other: placeboplacebo |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| niacinAlso: vitamin B3Niacin or nicotinic acid 250 mg tablets | Dietary supplement | niacin |
| placeboplacebo tablet | Other | placebo |
Primary outcome
Unified Parkinson's Disease Rating Scale (UPDRS) Change
Time frame: at the recruitment and after 6 months
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.
REM Sleep Pattern
Time frame: baseline and after 6 months
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.
Deep Sleep
Time frame: At baseline and after 6 months
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.
Light Sleep
Time frame: baseline and 6 months
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.
Sleep Time - Awake
Time frame: at baseline and 6 months
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.
Mini-Mental State Examination (MMSE) Change
Time frame: at baseline and after 6 months of treatment
It captures mental status and awareness of time, place and surrounding. A zero is minimum and 30 is maximum. Higher score indicates better cognition.
Stroop Test Change
Time frame: at the baseline and after 6 months of intervention
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.
Fatigue Severity Scale
Time frame: at baseline and after 6 months
Fatigue was rated from 0-7 in a fatigue questionnaire. A 0 being the least and 7 being the highest level of fatigue.
28 secondary outcomes
Cerebrospinal Fluid Changes - Interleukin 6 (IL6)
Time frame: at baseline and after 6 months
Cerebrospinal Fluid Changes - Interleukin 10 (IL-10)
Time frame: at baseline and after 6 months
Niacin Metabolite in Urine - Niacin
Time frame: at baseline and after 6 months
Niacin Metabolites in Urine - NAM Nicotinamide
Time frame: at baseline and 6 months
Niacin Changes in Plasma - Niacin
Time frame: baseline and 6 months
Niacin Changes in Plasma - NUA Nicotinuric Acid
Time frame: at baseline and 6 months
Cerebrospinal Fluid Changes - Interleukin 8 (IL8)
Time frame: at baseline and after 6 months
Niacin Metabolite in Urine - Nicotinuric Acid NUA
Time frame: at baseline and after 6 months
CSF Fluid Changes - Interleukin 1B (IL-1B)
Time frame: at baseline and 6 months
Cerebrospinal Fluid (CSF) Changes - Macrophage Inflammatory Protein 1 Beta (MIP 1 Beta)
Time frame: at baseline and after 6 months
Macrophage Changes
Time frame: at baseline and after 6 months
Niacin Metabolite Changes in Plasma - Nicotinamide (NAM)
Time frame: at baseline and after 6 months
CSF Changes in Interferon Gamma (IF-gamma)
Time frame: at baseline and after 6 months
CSF Changes - Tumor Necrosis Factor - Alpha (TNF-alpha)
Time frame: at baseline and after 6 months
Cerebral Spinal Fluid Changes - Interferon Gamma Induced Protein -10 (IP-10)
Time frame: at baseline and after 6 months
Cerebral Spinal Fluid (CSF) Changes - Monocyte Chemoattractant Protein 4 (MCP4)
Time frame: at baseline and after 6 months
Cerebral Spinal Fluid (CSF) Changes - MIP1-alpha
Time frame: at baseline and after 6 months
Plasma Cytokines - IF Gamma
Time frame: at baseline and after 6 months
Plasma Cytokines - IL-10
Time frame: at baseline and after 6 months
Plasma Cytokines - IL1-B
Time frame: at baseline and after 6 months
Plasma Cytokines - IL-6
Time frame: at baseline and after 6 months
Plasma Cytokines - IL-8
Time frame: at baseline and after 6 Months
Plasma Cytokines - TNF-alpha
Time frame: at baseline and after 6 months
Plasma Cytokines - IP-10
Time frame: at baseline and after 6 months
Plasma Cytokines - MCP-4
Time frame: at baseline and after 6 months
Plasma Cytokines - MIP1-alpha
Time frame: at baseline and after 6 months
Plasma Cytokines - MIP1-beta
Time frame: at baseline and after 6 months
Plasma Levels - Serotonin
Time frame: at baseline and after 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. As the investigators request, we will share the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chandramohan Wakade, MBBS principal investigator
Charlie Norwood VA Medical Center, Augusta, GA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing niacin in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson's Disease Rating Scale (UPDRS) Change (time frame: at the recruitment and after 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.