Status:
TERMINATED
Low Dose Niacin (Vitamin B3) for Parkinson's Disease
Lead Sponsor:
VA Office of Research and Development
Conditions:
Parkinson's Disease
Eligibility:
All Genders
35+ years
Phase:
NA
Brief Summary
(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 re...
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 Pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03808961
Start Date
January 1 2020
End Date
November 1 2023
Last Update
March 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Charlie Norwood VA Medical Center, Augusta, GA
Augusta, Georgia, United States, 30904-6258