Niacin for Parkinsons Disease

Parkinson's Disease Clinical Trial

— NAPS  

Official title:

NAPS: Niacin for Parkinsons Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03808961
• Other study ID #: NURE-013-18S
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Dietary Supplement:
• Niacin
100mg tablets twice daily
• Niacinamide
100mg tablets twice daily

Other:
• Placebo
Placebo tablet twice daily

Locations

Country	Name	City	State
United States	Charlie Norwood VA Medical Center, Augusta, GA	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 6 month, 12 month and 18 months
Primary	Mini-Mental State Examination (MMSE) change	It captures mental status and awareness of time, place and surrounding.	Baseline, 6 month, 12 month and 18 months
Primary	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.	Baseline, 6 month, 12 month and 18 months
Primary	Niacin changes	Plasma and urine samples will be tested to report levels of niacin and its metabolites.	Baseline, 6 month, 12 month and 18 months
Secondary	Visual analogue fatigue scale changes	Fatigue is self-reported on the Visual analogue fatigue scale (VAFS).	Baseline, 6 month, 12 month and 18 months
Secondary	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.	Baseline, 6 month, 12 month and 18 months
Secondary	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.	Baseline, 6 month, 12 month and 18 months