Niacin for Parkinsons Disease (NAPS)
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|ClinicalTrials.gov Identifier: NCT03808961|
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Dietary Supplement: Niacin Dietary Supplement: Niacinamide Other: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Chandramohan Wakade, MBBS||(706) 733-0188 ext 2378||Chandramohan.Wakade@va.gov|
|Contact: John Morgan, MD||(706) firstname.lastname@example.org|
|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|
|Principal Investigator:||Chandramohan Wakade, MBBS||Charlie Norwood VA Medical Center, Augusta, GA|