Niacin for Parkinsons Disease

NAPS: Niacin for Parkinsons Disease

Sponsors

Lead Sponsor: VA Office of Research and Development

Source 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.

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.

Overall Status Recruiting
Start Date 2020-01-01
Completion Date 2024-04-01
Primary Completion Date 2023-11-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS) change Baseline, 6 month, 12 month and 18 months
Mini-Mental State Examination (MMSE) change Baseline, 6 month, 12 month and 18 months
Stroop test change Baseline, 6 month, 12 month and 18 months
Sleep test change Baseline, 6 month, 12 month and 18 months
Macrophage and cytokine changes Baseline, 6 month, 12 month and 18 months
Niacin changes Baseline, 6 month, 12 month and 18 months
Cerebrospinal Fluid (CSF) changes Baseline, and 18 months
Enrollment 100
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Niacin

Description: 100mg tablets twice daily

Arm Group Label: Group 1 ? Niacin Arm

Other Name: Vitamin B3, Nicotinic acid

Intervention Type: Dietary Supplement

Intervention Name: Niacinamide

Description: 100mg tablets twice daily

Arm Group Label: Group 2 ? Niacinamide Arm

Other Name: Vitamin B3, Nicotinamide

Intervention Type: Other

Intervention Name: Placebo

Description: Placebo tablet

Arm Group Label: Group 3 ? Placebo Wait-listed Arm

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

Gender:

All

Minimum Age:

35 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Chandramohan Wakade, MBBS Principal Investigator Charlie Norwood VA Medical Center, Augusta, GA
Overall Contact

Last Name: Chandramohan Wakade, MBBS

Phone: (706) 733-0188

Phone Ext.: 2378

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Charlie Norwood VA Medical Center, Augusta, GA Thomas J Hartney, MD 706-733-0188 2510 [email protected] Chandramohan Wakade, MBBS Principal Investigator
Location Countries

United States

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Group 1 ? Niacin Arm

Type: Active Comparator

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

Label: Group 2 ? Niacinamide Arm

Type: Active Comparator

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

Label: Group 3 ? Placebo Wait-listed Arm

Type: Placebo Comparator

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

Acronym NAPS
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: There are three arms, niacin, niacinamide and placebo. They are double blind and randomized.

Primary Purpose: Health Services Research

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: Only Pharmacists keep the log of the drug dispensed. Everyone else is blinded.

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 [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News