Low Dose Niacin (Vitamin B3) for Parkinson's Disease

NCT03808961 | Terminated Results DMC

• 1 other identifier: NURE-013-18S
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease, Niacin, Niacinamide; Niacin; Niacinamide

Outcome Measures

Primary Outcomes (2)

• 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. The values reported are the averages of baseline, 6months, 12 months, and 18 months values combined for all the participants in that group. So, in the niacin and the niacinamide groups, it indicated the average of 8 values and in the control group it is the average of 12 values. A score is recorded according to the motor skills recorded ranging from 0-5 in each test, 0 being normal and 5 being affected most. Scores are given judging the motor skills. The score may range between 0-132. Lower scores indicate better outcome.

  Baseline, 6 month, 12 month and 18 months

• Mini-Mental State Examination (MMSE) Change

  It captures mental status and awareness of time, place and surrounding. Score ranges from 0-30, 30 denotes the best score and best mental status. All the values in the group are pooled for an average score at baseline, 6 months, 12 months, and 18 months. Therefore, Niacin and Niacinamide groups each demonstrates average of 8 values while placebo group shows average of 12 values.

  Baseline, 6 month, 12 month and 18 months

Secondary Outcomes (2)

• Visual Analogue Fatigue Scale Changes

  Baseline, 6 month, 12 month and 18 months

• Trail Making Test Time Change

  Baseline, 6 month, 12 month and 18 months

Study Arms (3)

Group 1 - Niacin Arm

ACTIVE COMPARATOR

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

Group 2 - Niacinamide Arm

ACTIVE COMPARATOR

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

Group 3 - Placebo Wait-listed Arm

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Niacin DIETARY_SUPPLEMENT

100mg tablets twice daily

Also known as: Vitamin B3, Nicotinic acid

Group 1 - Niacin Arm

Niacinamide DIETARY_SUPPLEMENT

100mg tablets twice daily

Also known as: Vitamin B3, Nicotinamide

Group 2 - Niacinamide Arm

Placebo OTHER

Placebo tablet twice daily

Group 3 - Placebo Wait-listed Arm

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• New York Heart Association Class III or IV congestive heart failure
• endocarditis

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Charlie Norwood VA Medical Center, Augusta, GA

Augusta, Georgia, 30904-6258, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Niacin; Niacinamide

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Chandramohan Wakade
• Organization: VAORD

cwakade@augusta.edu

7067211106

Study Officials

• Chandramohan Wakade, MBBS

  Charlie Norwood VA Medical Center, Augusta, GA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only Pharmacists keep the log of the drug dispensed. Everyone else is blinded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 18, 2019
• Study Start: January 1, 2020
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

US (1)