NCT03808961: NAPS

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

Terminated NA Results posted Last updated 4 March 2025

What this trial tests

NA trial testing Niacin in Parkinson's Disease in 7 participants. Terminated before completion.

Timeline

1 January 2020

Primary endpoint
1 November 2023

1 November 2023

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	health services research
Enrollment	7
Start date	1 January 2020
Primary completion	1 November 2023
Estimated completion	1 November 2023
Sites	1 location across United States

Drugs / interventions tested

• Niacin (NIACIN) — full drug profile →
• Niacinamide — full drug profile →
• Placebo

Conditions studied

• Parkinson's Disease — all drugs for Parkinson's Disease →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

35 and older, any sex, with Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Unified Parkinson's Disease Rating Scale (UPDRS) Change Primary · Baseline, 6 month, 12 month and 18 months

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

Group	Value	95% CI
Group 1 - Niacin Arm	40.5	± 10
Group 2 - Niacinamide Arm	20.5	± 2.5
Group 3 - Placebo Wait-listed Arm	17.5	± 12

Mini-Mental State Examination (MMSE) Change Primary · Baseline, 6 month, 12 month and 18 months

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.

Group	Value	95% CI
Group 1 - Niacin Arm	29.57	± 1.04
Group 2 - Niacinamide Arm	29.4	± 1.2
Group 3 - Placebo Wait-listed Arm	30	± 0

Visual Analogue Fatigue Scale Changes Secondary · Baseline, 6 month, 12 month and 18 months

Fatigue is self-reported on the Visual analogue fatigue scale (VAFS). Participants were asked about how much fatigue they feel ranging from no fatigue (score 0) to extreme fatigue (score 10). Each participant was asked about this score at baseline, 6 months, 12 months, and 18 months visit. Data reported is the averages of all the scores from that group for all the time points.

Group	Value	95% CI
Group 1 - Niacin Arm	5.75	± 1.5
Group 2 - Niacinamide Arm	5.75	± 1.5
Group 3 - Placebo Wait-listed Arm	8.8	± 2.5

Sponsor's own description

(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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. NAD<sup>+</sup> metabolism and its roles in cellular processes during ageing.
   Covarrubias AJ, Perrone R, Grozio A, Verdin E. · · 2021 · cited 1089× · PMID 33353981 · DOI 10.1038/s41580-020-00313-x
2. NAD⁺ metabolism: pathophysiologic mechanisms and therapeutic potential.
   Xie N, Zhang L, Gao W, Huang C, et al · · 2020 · cited 744× · PMID 33028824 · DOI 10.1038/s41392-020-00311-7
3. The niacin receptor HCAR2 modulates microglial response and limits disease progression in a mouse model of Alzheimer's disease.
   Moutinho M, Puntambekar SS, Tsai AP, Coronel I, et al · · 2022 · cited 71× · PMID 35320002 · DOI 10.1126/scitranslmed.abl7634
4. Clinical Evidence for Targeting NAD Therapeutically.
   Radenkovic D, Reason, Verdin E. · · 2020 · cited 45× · PMID 32942582 · DOI 10.3390/ph13090247
5. The Promise of Niacin in Neurology.
   Wuerch E, Urgoiti GR, Yong VW. · · 2023 · cited 38× · PMID 37084148 · DOI 10.1007/s13311-023-01376-2
6. Roles of NAD<sup>+</sup> in Health and Aging.
   Lautrup S, Hou Y, Fang EF, Bohr VA. · · 2024 · cited 28× · PMID 37848251 · DOI 10.1101/cshperspect.a041193
7. Structural basis of hydroxycarboxylic acid receptor signaling mechanisms through ligand binding.
   Suzuki S, Tanaka K, Nishikawa K, Suzuki H, et al · · 2023 · cited 15× · PMID 37736747 · DOI 10.1038/s41467-023-41650-7
8. Structural insights into ligand recognition and selectivity of the human hydroxycarboxylic acid receptor HCAR2.
   Pan X, Ye F, Ning P, Zhang Z, et al · · 2023 · cited 12× · PMID 38012147 · DOI 10.1038/s41421-023-00610-7