- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03808961
Niacin for Parkinsons Disease (NAPS)
NAPS: Niacin for Parkinsons Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Augusta, Georgia, United States, 30904-6258
- Charlie Norwood VA Medical Center, Augusta, GA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
100mg tablets twice daily
Other Names:
|
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
|
100mg tablets twice daily
Other Names:
|
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
|
Placebo tablet twice daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 part III of the UPDRS regarding motor skills.
|
Baseline, 6 month, 12 month and 18 months
|
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.
|
Baseline, 6 month, 12 month and 18 months
|
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.
|
Baseline, 6 month, 12 month and 18 months
|
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.
|
Baseline, 6 month, 12 month and 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue fatigue scale changes
Time Frame: Baseline, 6 month, 12 month and 18 months
|
Fatigue is self-reported on the Visual analogue fatigue scale (VAFS).
|
Baseline, 6 month, 12 month and 18 months
|
Trail making test time change
Time Frame: Baseline, 6 month, 12 month and 18 months
|
This is a timed test where the patient connects numbers in order for part A. Numbers and letters are connected interchangeably in past B.
The time of B minus the time of A gives a measure for set shift change ability which is reduced in Parkinson's patients.
|
Baseline, 6 month, 12 month and 18 months
|
Arm strength and fatigue
Time Frame: Baseline, 6 month, 12 month and 18 months
|
An electromyogram is performed on each arm of the patient.
The test is recorded and aims to measure muscle strength and fatigue.
Patients squeeze a bulb as hard as possible, then hold it for 30 seconds.
This is done three times for each hand.
|
Baseline, 6 month, 12 month and 18 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Chandramohan Wakade, MBBS, Charlie Norwood VA Medical Center, Augusta, GA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Antimetabolites
- Micronutrients
- Hypolipidemic Agents
- Lipid Regulating Agents
- Vitamins
- Vitamin B Complex
- Nicotinic Acids
- Niacinamide
- Niacin
Other Study ID Numbers
- NURE-013-18S
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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 register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson's Disease
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
Assistance Publique - Hôpitaux de ParisFrance Parkinson AssociationUnknownHealthy Controls | Parkinson's Disease With LRRK2 Mutation | Parkinson's Disease Without LRRK2 MutationFrance
-
University Hospital, GrenobleCompletedParkinson's Disease (Disorder)France
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
Universidade Federal de PernambucoCompletedParkinson's Disease.Brazil
-
Shanghai East HospitalShanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaRecruitingIdiopathic Parkinson's DiseaseChina
-
Beijing Tiantan HospitalRecruitingPD - Parkinson's DiseaseChina
-
AbbVieActive, not recruitingParkinson's Disease (PD)United States, Australia
-
AbbVieCompletedParkinson's Disease (PD)United States, Australia
-
BlueRock TherapeuticsMemorial Sloan Kettering Cancer CenterActive, not recruitingAdvanced Parkinson's DiseaseUnited States, Canada
Clinical Trials on Niacin
-
Eunice Kennedy Shriver National Institute of Child...TerminatedObesity | Growth Hormone Deficiency | Short StatureUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedCardiovascular DiseaseUnited States
-
Merck Sharp & Dohme LLCCompletedHypercholesterolemia | Hyperlipidemia
-
University of PennsylvaniaCompletedHealthy VolunteersUnited States
-
Merck Sharp & Dohme LLCCompletedPrimary Hypercholesterolaemia | Mixed Hyperlipidaemia
-
University of LeipzigCompletedCoronary Disease | HypolipoproteinemiaGermany
-
University of WashingtonUpsher-Smith LaboratoriesCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Organon and CoCompleted