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Vitamin
Niacin for Parkinson's Disease (NAPS Trial)
N/A
Waitlist Available
Led By Chandramohan Wakade, MBBS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 month, 12 month and 18 months
Awards & highlights
NAPS Trial Summary
This trial will look for evidence of inflammation in people with Parkinson's, and whether vitamin B3 supplementation can reduce inflammation or improve symptoms.
Who is the study for?
This trial is for adults with mild to moderately severe Parkinson's Disease, who have been stable on PD medication for at least 3 months. Participants must not have significant cognitive deficits, dementia, severe neurological issues other than PD, or serious heart, lung, liver, kidney diseases. They should not be allergic to vitamin B3 and can't be taking high doses of it.Check my eligibility
What is being tested?
The study is testing if 18 months of vitamin B3 (niacin or niacinamide) supplementation can reduce inflammation and improve motor and non-motor symptoms in Parkinson's patients. It compares the effects of niacin against a placebo and examines biological markers in blood, urine, and spinal fluid.See study design
What are the potential side effects?
While the side effects are not detailed here, common side effects of niacin include skin flushing or rash, itching, headaches, dizziness; less commonly it may affect blood sugar levels or cause gastrointestinal discomfort.
NAPS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 month, 12 month and 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 month, 12 month and 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Macrophage and cytokine changes
Mini-Mental State Examination (MMSE) change
Niacin changes
+1 moreSecondary outcome measures
Arm strength and fatigue
Trail making test time change
Visual analogue fatigue scale changes
NAPS Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Group 2 ? Niacinamide ArmActive Control1 Intervention
Oral 100 mg fixed dose twice daily (200 mg total / day) x 18-months with assessments @ baseline, 6 month, 12 month and 18 months
Group II: Group 1 ? Niacin ArmActive Control1 Intervention
Oral 100 mg fixed dose twice daily x 18-months (200 mg total / day) with assessments @ baseline, 6 month, 12 month and 18 months
Group III: Group 3 ? Placebo Wait-listed ArmPlacebo Group1 Intervention
Oral placebo twice daily x 18- months with assessments @ baseline, 6 month, 12 month and 18 months
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,596 Total Patients Enrolled
Chandramohan Wakade, MBBSPrincipal InvestigatorCharlie Norwood VA Medical Center, Augusta, GA
1 Previous Clinical Trials
47 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have severe vision problems or amputations above the forefoot, and you should not have any physical issues that prevent you from doing physical tests.You cannot be allergic to vitamin B3.Most people in the study are expected to be over 60 years old.You cannot be taking high doses of vitamin B3, but you can take a B complex with a very low dose of B3 (25 mg) that has minimal effects on GPR109A.Your disease is at Stages I to IV, as measured by the modified Hoehn & Yahr scale, while you are in an active state.You were diagnosed with Parkinson's disease at least six months before joining the study.You have at least two of the main symptoms of Parkinson's disease, like shaking, stiffness, slow movement, or trouble with posture and walking, and there's no other known reason for these symptoms.You have had brain surgery or serious neurological problems, like a significant stroke or Alzheimer's disease.If you have serious heart, lung, liver, stomach, kidney problems, or uncontrolled diabetes, you cannot participate.People with mild to moderate Parkinson's disease can participate if they are adults.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2 ? Niacinamide Arm
- Group 2: Group 3 ? Placebo Wait-listed Arm
- Group 3: Group 1 ? Niacin Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings yet for individuals to participate in this research?
"According to information featured on clinicaltrials.gov, this medical trial does not currently have any available positions for patients. While the study was initially posted in January of 2020 and last updated March 8th 2022, 488 other investigations are actively looking for participants at present."
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