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Niacin for Parkinsons Disease (NAPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03808961
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Dietary Supplement: Niacin Dietary Supplement: Niacinamide Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There are three arms, niacin, niacinamide and placebo. They are double blind and randomized.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Only Pharmacists keep the log of the drug dispensed. Everyone else is blinded.
Primary Purpose: Health Services Research
Official Title: NAPS: Niacin for Parkinsons Disease
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine


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
Dietary Supplement: Niacin
100mg tablets twice daily
Other Name: 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
Dietary Supplement: Niacinamide
100mg tablets twice daily
Other Name: 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
Other: Placebo
Placebo tablet




Primary Outcome Measures :
  1. 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 I, II, III and V components of the UPDRS. UPDRS 3 is motor skills.

  2. 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.

  3. Stroop test change [ Time Frame: Baseline, 6 month, 12 month and 18 months ]
    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 score is desired within given time. Three initial trials are given to understand the test.

  4. Sleep test change [ Time Frame: Baseline, 6 month, 12 month and 18 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.

  5. 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.

  6. 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.

  7. Cerebrospinal Fluid (CSF) changes [ Time Frame: Baseline, and 18 months ]
    Inflammatory and non-inflammatory cytokines levels will be tested in CSF at baseline and 18 months after intervention.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808961


Contacts
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Contact: Chandramohan Wakade, MBBS (706) 733-0188 ext 2378 Chandramohan.Wakade@va.gov
Contact: John Morgan, MD (706) 733-0188 john.morgan@va.gov

Locations
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United States, Georgia
Charlie Norwood VA Medical Center, Augusta, GA Recruiting
Augusta, Georgia, United States, 30904
Contact: Thomas J Hartney, MD    706-733-0188 ext 2510    Tom.Hartney@va.gov   
Contact: James P Hill    (706) 733-0188 ext 2508    James.Hill5@va.gov   
Principal Investigator: Chandramohan Wakade, MBBS         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Chandramohan Wakade, MBBS Charlie Norwood VA Medical Center, Augusta, GA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03808961    
Other Study ID Numbers: NURE-013-18S
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: As the investigators request, we will share the data
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: One year after the study is closed.
Access Criteria: When we are ready to publish, the data will be available

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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
Keywords provided by VA Office of Research and Development:
Parkinson's disease, Niacin, Niacinamide
Niacin
Niacinamide
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Vitamins
Niacin
Niacinamide
Nicotinic Acids
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents