Niacin for Parkinsons Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 29 January 2024
• Main ID: NCT03808961
• Date of registration: 16/01/2019
• Prospective Registration: Yes
• Primary sponsor: VA Office of Research and Development
• Public title: Niacin for Parkinsons Disease NAPS
• Scientific title: NAPS: Niacin for Parkinsons Disease
• Date of first enrolment: January 1, 2020
• Target sample size: 7
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT03808961
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Chandramohan Wakade, MBBS
• Affiliation: Charlie Norwood VA Medical Center, Augusta, GA

Key inclusion & exclusion criteria

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



Age minimum: 35 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Other: Placebo

Dietary Supplement: Niacinamide

Dietary Supplement: Niacin

Primary Outcome(s)

Macrophage and cytokine changes [Time Frame: Baseline, 6 month, 12 month and 18 months]

Niacin changes [Time Frame: 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]

Mini-Mental State Examination (MMSE) change [Time Frame: Baseline, 6 month, 12 month and 18 months]

Secondary Outcome(s)

Arm strength and fatigue [Time Frame: Baseline, 6 month, 12 month and 18 months]

Trail making test time change [Time Frame: Baseline, 6 month, 12 month and 18 months]

Visual analogue fatigue scale changes [Time Frame: Baseline, 6 month, 12 month and 18 months]

Secondary ID(s)

NURE-013-18S

Source(s) of Monetary Support

Please refer to primary and secondary sponsors