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Niacin for Parkinsons Disease (NAPS)

Primary Purpose

Parkinson's Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Niacin
Niacinamide
Placebo
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Parkinson's Disease focused on measuring Parkinson's disease, Niacin, Niacinamide, Niacin, Niacinamide

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charlie Norwood VA Medical Center, Augusta, GA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group 1 ? Niacin Arm

Group 2 ? Niacinamide Arm

Group 3 ? Placebo Wait-listed Arm

Arm Description

Oral 100 mg fixed dose twice daily x 18-months (200 mg total / day) with assessments @ baseline, 6 month, 12 month and 18 months

Oral 100 mg fixed dose twice daily (200 mg total / day) x 18-months with assessments @ baseline, 6 month, 12 month and 18 months

Oral placebo twice daily x 18- months with assessments @ baseline, 6 month, 12 month and 18 months

Outcomes

Primary Outcome Measures

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.
Mini-Mental State Examination (MMSE) change
It captures mental status and awareness of time, place and surrounding.
Macrophage and cytokine changes
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.
Niacin changes
Plasma and urine samples will be tested to report levels of niacin and its metabolites.

Secondary Outcome Measures

Visual analogue fatigue scale changes
Fatigue is self-reported on the Visual analogue fatigue scale (VAFS).
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.
Arm strength and fatigue
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.

Full Information

First Posted
January 16, 2019
Last Updated
March 8, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03808961
Brief Title
Niacin for Parkinsons Disease
Acronym
NAPS
Official Title
NAPS: Niacin for Parkinsons Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Niacin, Niacinamide, Niacin, Niacinamide

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are three arms, niacin, niacinamide and placebo. They are double blind and randomized.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Only Pharmacists keep the log of the drug dispensed. Everyone else is blinded.
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 ? Niacin Arm
Arm Type
Active Comparator
Arm Description
Oral 100 mg fixed dose twice daily x 18-months (200 mg total / day) with assessments @ baseline, 6 month, 12 month and 18 months
Arm Title
Group 2 ? Niacinamide Arm
Arm Type
Active Comparator
Arm Description
Oral 100 mg fixed dose twice daily (200 mg total / day) x 18-months with assessments @ baseline, 6 month, 12 month and 18 months
Arm Title
Group 3 ? Placebo Wait-listed Arm
Arm Type
Placebo Comparator
Arm Description
Oral placebo twice daily x 18- months with assessments @ baseline, 6 month, 12 month and 18 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Niacin
Other Intervention Name(s)
Vitamin B3, Nicotinic acid
Intervention Description
100mg tablets twice daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Niacinamide
Other Intervention Name(s)
Vitamin B3, Nicotinamide
Intervention Description
100mg tablets twice daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet twice daily
Primary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (UPDRS) change
Description
This is the Unified Parkinson's disease rating scale assessment. The investigators assess part III of the UPDRS regarding motor skills.
Time Frame
Baseline, 6 month, 12 month and 18 months
Title
Mini-Mental State Examination (MMSE) change
Description
It captures mental status and awareness of time, place and surrounding.
Time Frame
Baseline, 6 month, 12 month and 18 months
Title
Macrophage and cytokine changes
Description
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.
Time Frame
Baseline, 6 month, 12 month and 18 months
Title
Niacin changes
Description
Plasma and urine samples will be tested to report levels of niacin and its metabolites.
Time Frame
Baseline, 6 month, 12 month and 18 months
Secondary Outcome Measure Information:
Title
Visual analogue fatigue scale changes
Description
Fatigue is self-reported on the Visual analogue fatigue scale (VAFS).
Time Frame
Baseline, 6 month, 12 month and 18 months
Title
Trail making test time change
Description
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.
Time Frame
Baseline, 6 month, 12 month and 18 months
Title
Arm strength and fatigue
Description
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.
Time Frame
Baseline, 6 month, 12 month and 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chandramohan Wakade, MBBS
Organizational Affiliation
Charlie Norwood VA Medical Center, Augusta, GA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charlie Norwood VA Medical Center, Augusta, GA
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30904
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Niacin for Parkinsons Disease

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