Parkinson's DiseaseNAPSNCT03808961
Low Dose Niacin (Vitamin B3) for Parkinson's Disease
A study testing Niacin and Niacinamide in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.
Trial summary
(1) To examine the blood, urine and spinal fluid of persons with Parkinson's to look for evidence of inflammation and; (2) whether 18 months of vitamin B3(niacin or niacinamide) supplementation may reduce the inflammation and/or improve PD motor and non-motor symptoms. 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 and Niacinamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 1 Nov 2023
- 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
- The majority of PD subjects are expected to be > 60 years old
- Disease severity is defined as modified Hoehn \& Yahr Stages I-IV (while "On")
- PD is defined according to the UK 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
Show all 12Show fewer
- rigidity
- bradykinesia
- 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
- The patient will have signed informed consent
Who cannot join
- Subjects will be excluded if they present with significant cognitive deficits
- A MMSE score of 25 is considered substantial global cognitive impairment
- Subjects will be excluded if they had previous brain surgery or other severe neurological problems
- intracerebral hemorrhage
- traumatic brain injury
- central nervous system malignancy
Show all 23Show fewer
- active central nervous system (CNS) infection
- significant stroke
- 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
- Subjects must not have known allergy to vitamin B3
- Significant cardiac, pulmonary, hepatic, gastrointestinal, renal disease, or uncontrolled/advanced diabetes are also exclusionary factors, 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 (AV) block
- sick sinus syndrome
- Subjects will be excluded if they are taking B3 but will be included if they are taking B complex that has very low dose B3 (25 mg) which has minimal effects on GPR109A (based on our unpublished observation)
- Overall, the investigators will exercise clinical judgment to exclude a subject from the study if, in the investigators' opinion, that a patient presents with a set of comorbidities which renders unsuitability for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Charlie Norwood VA Medical Center, Augusta, GA
Augusta, Georgia, 30904-6258
About this study
Official title: NAPS: Niacin for Parkinson's Disease
(1) To examine the blood, urine and spinal fluid of persons with Parkinson's to look for evidence of inflammation and; (2) whether 18 months of vitamin B3(niacin or niacinamide) supplementation may reduce the inflammation and/or improve PD motor and non-motor symptoms.
Read the detailed description
Number of people affected by Parkinson's disease is increasing each year. Vitamin B3 (Niacin/Niacinamide) supplement can be used to slow the progression of PD.
Inflammation plays a central role in Parkinson's disease (PD) pathology as evidenced by the presence of microglia in the substantia nigra in post-mortem samples as well as activated microglia and cytokines in clinical and animal studies. The use of non-aspirin non-steroidal anti-inflammatory drugs was found to reduce the risk of PD. The investigators recently identified an anti-inflammatory receptor GPR109A that is upregulated in PD. 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. In a three month trial at Augusta University (the investigators' affiliate) the investigators demonstrated that niacin was helpful for PD patients in reducing inflammatory macrophages and boosting the anti-inflammatory macrophages in blood.
In this VA-funded study, the investigators will determine the effect of 18 months over-the-counter (OTC) niacin or niacinamide supplementation on inflammation (as assessed in the blood and spinal fluid) and severity of the PD symptoms.
- Conditions
- Parkinson's Disease
- Being tested
- Niacin, Niacinamide, Placebo
- Keywords
- Parkinson's disease, Niacin, Niacinamide, Niacin, Niacinamide
- 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, Nicotinic acid
100mg tablets twice daily
NiacinamideDietary supplement
Also called Vitamin B3, Nicotinamide
100mg tablets twice daily
PlaceboOther
Placebo tablet twice daily
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Niacin Arm | Active comparator | Oral 100 mg fixed dose twice daily x 18-months (200 mg total / day) with assessments @ baseline, 6 month, 12 month and 18 months Receives: Dietary Supplement: Niacin |
| Group 2 - Niacinamide Arm | Active comparator | Oral 100 mg fixed dose twice daily (200 mg total / day) x 18-months with assessments @ baseline, 6 month, 12 month and 18 months Receives: Dietary Supplement: Niacinamide |
| Group 3 - Placebo Wait-listed Arm | Placebo comparator | Oral placebo twice daily x 18- months with assessments @ baseline, 6 month, 12 month and 18 months 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 part III of the UPDRS regarding motor skills. The values reported are the averages of baseline, 6months, 12 months, and 18 months values combined for all the participants in that group. So, in the niacin and the niacinamide groups, it indicated the average of 8 values and in the control group it is the average of 12 values. A score is recorded according to the motor skills recorded ranging from 0-5 in each test, 0 being normal and 5 being affected most. Scores are given judging the motor skills. The score may range between 0-132. Lower scores indicate better outcome.
Measured: Baseline, 6 month, 12 month and 18 months
Mini-Mental State Examination (MMSE) Change
It captures mental status and awareness of time, place and surrounding. Score ranges from 0-30, 30 denotes the best score and best mental status. All the values in the group are pooled for an average score at baseline, 6 months, 12 months, and 18 months. Therefore, Niacin and Niacinamide groups each demonstrates average of 8 values while placebo group shows average of 12 values.
Measured: Baseline, 6 month, 12 month and 18 months
Secondary outcomes (2)
Visual Analogue Fatigue Scale Changes
Fatigue is self-reported on the Visual analogue fatigue scale (VAFS). Participants were asked about how much fatigue they feel ranging from no fatigue (score 0) to extreme fatigue (score 10). Each participant was asked about this score at baseline, 6 months, 12 months, and 18 months visit. Data reported is the averages of all the scores from that group for all the time points.
Measured: Baseline, 6 month, 12 month and 18 months
Trail Making Test Time Change
This is a timed test where the patient connects numbers in order for part A. Numbers and letters are connected interchangeably in past B. The time of B minus the time of A gives a measure for set shift change ability which is reduced in Parkinson's patients. Each A and B demonstrates averages from baseline, 6 months, 12 months and 18 months of all the participants. Therefore, in the niacin group A and group B each show averages of 8 values while the control group shows averages of 12 values.
Measured: Baseline, 6 month, 12 month and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Jan 2020
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Why it stopped: Not enough recruitment
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 three arms, niacin, niacinamide and placebo. They are double blind and randomized.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 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
- NCT03808961
- Sponsor's protocol ID
- NURE-013-18S
- Acronym
- NAPS
- Status last verified
- Feb 2025
- First submitted
- 16 Jan 2019
- Last updated
- 4 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the investigators request, we will share the data
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAPS: Niacin for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03808961
- Acronym / sponsor ID
- NAPS / NURE-013-18S
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Niacin, Niacinamide, Niacin, Niacinamide
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough recruitment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Posted 4 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
(1) To examine the blood, urine and spinal fluid of persons with Parkinson's to look for evidence of inflammation and; (2) whether 18 months of vitamin B3(niacin or niacinamide) supplementation may reduce the inflammation and/or improve PD motor and non-motor symptoms.
Detailed description
Number of people affected by Parkinson's disease is increasing each year. Vitamin B3 (Niacin/Niacinamide) supplement can be used to slow the progression of PD.
Inflammation plays a central role in Parkinson's disease (PD) pathology as evidenced by the presence of microglia in the substantia nigra in post-mortem samples as well as activated microglia and cytokines in clinical and animal studies. The use of non-aspirin non-steroidal anti-inflammatory drugs was found to reduce the risk of PD. The investigators recently identified an anti-inflammatory receptor GPR109A that is upregulated in PD. 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. In a three month trial at Augusta University (the investigators' affiliate) the investigators demonstrated that niacin was helpful for PD patients in reducing inflammatory macrophages and boosting the anti-inflammatory macrophages in blood.
In this VA-funded study, the investigators will determine the effect of 18 months over-the-counter (OTC) niacin or niacinamide 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
- 3
- Model description
- There are three arms, niacin, niacinamide and placebo. They are double blind and randomized.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Niacin Arm | Active comparator | Dietary Supplement: NiacinOral 100 mg fixed dose twice daily x 18-months (200 mg total / day) with assessments @ baseline, 6 month, 12 month and 18 months |
| Group 2 - Niacinamide Arm | Active comparator | Dietary Supplement: NiacinamideOral 100 mg fixed dose twice daily (200 mg total / day) x 18-months with assessments @ baseline, 6 month, 12 month and 18 months |
| Group 3 - Placebo Wait-listed Arm | Placebo comparator | Other: PlaceboOral placebo twice daily x 18- months with assessments @ baseline, 6 month, 12 month and 18 months |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- PD subjects will be adult men and women diagnosed with idiopathic mild to moderately severe PD
- The majority of PD subjects are expected to be > 60 years old
- Disease severity is defined as modified Hoehn \& Yahr Stages I-IV (while "On")
- PD is defined according to the UK 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:
Key exclusion criteria (23 listed)
- Subjects will be excluded if they present with significant cognitive deficits
- A MMSE score of 25 is considered substantial global cognitive impairment
- Subjects will be excluded if they had previous brain surgery or other severe neurological problems
- All subjects must be without evidence of dementia
- 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
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 B3, Nicotinic acid100mg tablets twice daily | Dietary supplement | Group 1 - Niacin Arm |
| NiacinamideAlso: Vitamin B3, Nicotinamide100mg tablets twice daily | Dietary supplement | Group 2 - Niacinamide Arm |
| PlaceboPlacebo tablet twice daily | Other | Group 3 - Placebo Wait-listed Arm |
Primary outcome
Unified Parkinson's Disease Rating Scale (UPDRS) Change
Time frame: Baseline, 6 month, 12 month and 18 months
This is the Unified Parkinson's disease rating scale assessment. The investigators assess part III of the UPDRS regarding motor skills. The values reported are the averages of baseline, 6months, 12 months, and 18 months values combined for all the participants in that group. So, in the niacin and the niacinamide groups, it indicated the average of 8 values and in the control group it is the average of 12 values. A score is recorded according to the motor skills recorded ranging from 0-5 in each test, 0 being normal and 5 being affected most. Scores are given judging the motor skills. The score may range between 0-132. Lower scores indicate better outcome.
Mini-Mental State Examination (MMSE) Change
Time frame: Baseline, 6 month, 12 month and 18 months
It captures mental status and awareness of time, place and surrounding. Score ranges from 0-30, 30 denotes the best score and best mental status. All the values in the group are pooled for an average score at baseline, 6 months, 12 months, and 18 months. Therefore, Niacin and Niacinamide groups each demonstrates average of 8 values while placebo group shows average of 12 values.
2 secondary outcomes
Visual Analogue Fatigue Scale Changes
Time frame: Baseline, 6 month, 12 month and 18 months
Trail Making Test Time Change
Time frame: Baseline, 6 month, 12 month and 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. At 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 and Niacinamide 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 12 inclusion and 23 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: stopped early, as of the sponsor's last update on 4 Mar 2025. 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 4 Mar 2025). 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: Baseline, 6 month, 12 month and 18 months). The study lists 2 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 4 Mar 2025.