Niacin for Parkinsons Disease (NAPS)

January 19, 2024 updated by: VA Office of Research and Development

NAPS: Niacin for Parkinsons 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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Augusta, Georgia, United States, 30904-6258
        • Charlie Norwood VA Medical Center, Augusta, GA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
    • 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

Exclusion Criteria:

  • 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
    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 ? Niacin Arm
Oral 100 mg fixed dose twice daily x 18-months (200 mg total / day) with assessments @ baseline, 6 month, 12 month and 18 months
100mg tablets twice daily
Other Names:
  • Vitamin B3, Nicotinic acid
Active Comparator: Group 2 ? Niacinamide Arm
Oral 100 mg fixed dose twice daily (200 mg total / day) x 18-months with assessments @ baseline, 6 month, 12 month and 18 months
100mg tablets twice daily
Other Names:
  • Vitamin B3, Nicotinamide
Placebo Comparator: Group 3 ? Placebo Wait-listed Arm
Oral placebo twice daily x 18- months with assessments @ baseline, 6 month, 12 month and 18 months
Placebo tablet twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 month, 12 month and 18 months
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.
Baseline, 6 month, 12 month and 18 months
Macrophage and cytokine changes
Time Frame: Baseline, 6 month, 12 month and 18 months
The blood is tested to report GPR109A levels in macrophages in M1 and M2 populations. Inflammatory and anti-inflammatory cytokine levels are measured in plasma.
Baseline, 6 month, 12 month and 18 months
Niacin changes
Time Frame: Baseline, 6 month, 12 month and 18 months
Plasma and urine samples will be tested to report levels of niacin and its metabolites.
Baseline, 6 month, 12 month and 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue fatigue scale changes
Time Frame: Baseline, 6 month, 12 month and 18 months
Fatigue is self-reported on the Visual analogue fatigue scale (VAFS).
Baseline, 6 month, 12 month and 18 months
Trail making test time change
Time Frame: Baseline, 6 month, 12 month and 18 months
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.
Baseline, 6 month, 12 month and 18 months
Arm strength and fatigue
Time Frame: Baseline, 6 month, 12 month and 18 months
An electromyogram is performed on each arm of the patient. The test is recorded and aims to measure muscle strength and fatigue. Patients squeeze a bulb as hard as possible, then hold it for 30 seconds. This is done three times for each hand.
Baseline, 6 month, 12 month and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Chandramohan Wakade, MBBS, Charlie Norwood VA Medical Center, Augusta, GA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

January 16, 2019

First Submitted That Met QC Criteria

January 16, 2019

First Posted (Actual)

January 18, 2019

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

At the investigators request, we will share the data

IPD Sharing Time Frame

One year after the study is closed.

IPD Sharing Access Criteria

When we are ready to publish, the data will be available

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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