N/A
N=47
GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT03462680 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Unified Parkinson's Disease Rating Scale (UPDRS) Change — 21.25; 22.4; 20.8; 22.31 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- niacin (Dietary_supplement); placebo (Other)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Unified Parkinson's Disease Rating Scale (UPDRS) Change |
21.25; 22.4; 20.8; 22.31 | — |
| PRIMARY REM Sleep Pattern |
20.09; 15.83; 21.1; 21.45 | — |
| PRIMARY Deep Sleep |
8.17; 8.48; 12.28; 8.32 | — |
| PRIMARY Light Sleep |
49.2; 53.5; 50.9; 47.5 | — |
| PRIMARY Sleep Time - Awake |
20.2; 21.95; 13.5; 23 | — |
| PRIMARY Mini-Mental State Examination (MMSE) Change |
29.94; 29.81; 29.94; 29.71 | — |
| PRIMARY Stroop Test Change |
6.18; 8.13; 8.37; 8.72 | — |
| PRIMARY Fatigue Severity Scale |
40.3; 36.7; 38.5; 36.7 | — |
| SECONDARY Cerebrospinal Fluid Changes - Interleukin 6 (IL6) |
1.6; 1.9; 1.2; 1.2 | — |
| SECONDARY Cerebrospinal Fluid Changes - Interleukin 10 (IL-10) |
0.42; 0.13; 0.09; 0.08 | — |
| SECONDARY Niacin Metabolite in Urine - Niacin |
1826.8; 1533; 1913.8; 1660.6 | — |
| SECONDARY Niacin Metabolites in Urine - NAM Nicotinamide |
815.5; 205.8; 1140.3; 685.4 | — |
| SECONDARY Niacin Changes in Plasma - Niacin |
68.5; 55.8; 80.83; 92.2 | — |
| SECONDARY Niacin Changes in Plasma - NUA Nicotinuric Acid |
0; 4.99; 313.9; 0.38 | — |
| SECONDARY Cerebrospinal Fluid Changes - Interleukin 8 (IL8) |
62.9; 102.5; 91.6; 77.9 | — |
| SECONDARY Niacin Metabolite in Urine - Nicotinuric Acid NUA |
3565.3; 1021.8; 20132.9; 2803.7 | — |
| SECONDARY CSF Fluid Changes - Interleukin 1B (IL-1B) |
0.56; 0.28; 0.21; 0.22 | — |
| SECONDARY Cerebrospinal Fluid (CSF) Changes - Macrophage Inflammatory Protein 1 Beta (MIP 1 Beta) |
14.7; 9.3; 15.9; 7.7 | — |
| SECONDARY Macrophage Changes |
54.08; 56; 48.92; 54.5 | — |
| SECONDARY Niacin Metabolite Changes in Plasma - Nicotinamide (NAM) |
0.43; 0.34; 1.07; 0.38 | — |
| SECONDARY CSF Changes in Interferon Gamma (IF-gamma) |
0.21; 0.39; 2.2; 0.89 | — |
| SECONDARY CSF Changes - Tumor Necrosis Factor - Alpha (TNF-alpha) |
0.53; 0.18; 0.23; 0.2 | — |
| SECONDARY Cerebral Spinal Fluid Changes - Interferon Gamma Induced Protein -10 (IP-10) |
359.8; 512; 936.2; 514.5 | — |
| SECONDARY Cerebral Spinal Fluid (CSF) Changes - Monocyte Chemoattractant Protein 4 (MCP4) |
24.6; 7.3; 3.9; 6.7 | — |
| SECONDARY Cerebral Spinal Fluid (CSF) Changes - MIP1-alpha |
17.8; 18.7; 20.5; 17.3 | — |
| SECONDARY Plasma Cytokines - IF Gamma |
16.2; 21; 84.8; 15.95 | — |
| SECONDARY Plasma Cytokines - IL-10 |
0.41; 0.41; 0.5; 0.41 | — |
| SECONDARY Plasma Cytokines - IL1-B |
0.32; 0.37; 0.23; 0.29 | — |
| SECONDARY Plasma Cytokines - IL-6 |
5.7; 8.7; 2.97; 11.04 | — |
| SECONDARY Plasma Cytokines - IL-8 |
6.7; 6.2; 8.1; 6.6 | — |
| SECONDARY Plasma Cytokines - TNF-alpha |
2.05; 0.96; 2.26; 1.0 | — |
| SECONDARY Plasma Cytokines - IP-10 |
443.3; 402.7; 542.1; 355.4 | — |
| SECONDARY Plasma Cytokines - MCP-4 |
112.3; 104.6; 106.4; 90.7 | — |
| SECONDARY Plasma Cytokines - MIP1-alpha |
23.3; 42.1; 23.2; 38.9 | — |
| SECONDARY Plasma Cytokines - MIP1-beta |
69.3; 65.8; 65.5; 56 | — |
| SECONDARY Plasma Levels - Serotonin |
84.2; 89.6; 83; 64.2 | — |
Summary
Inflammation plays a central role in Parkinson's disease. The use of anti-inflammatory drugs was found to reduce the risk of PD . Niacin may play an important role in reducing inflammation in PD. The investigators also found that individuals with PD have a chronic niacin deficiency .
The purposes of this study are to (1) examine the blood, urine and spinal fluid of persons with Parkinson's to look for evidence of inflammation and; (2) whether 6 months of vitamin B3 supplements may reduce the inflammation and/or improve symptoms.
Eligibility Criteria
Inclusion Criteria
- PD subjects will be adult men and women diagnosed with idiopathic mild to moderately severe PD defined as modified Hoehn & Yahr Stages I-III (while "On").
- PD is defined according to the United Kingdom 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, and 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, i.e., they will be tested while "On."
- The patient will have signed informed consent.
- Subjects who do not have PD (i.e., healthy or have other medical conditions such as traumatic brain injury (TBI), stroke, or other syndromes in which inflammation plays a role in the condition) will also be recruited as control subjects.
- This will allow us to estimate whether these other conditions show similar or unique inflammatory profile.
Exclusion Criteria
- 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
- Allergic to niacin
- Significant cardiac, pulmonary, hepatic, gastrointestinal, or renal disease
- 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 block or sick sinus syndrome), or diabetes are also exclusionary factors
Data sourced from ClinicalTrials.gov (NCT03462680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.