GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03462680
• Date of registration: 22/02/2018
• Prospective Registration: No
• Primary sponsor: VA Office of Research and Development
• Public title: GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures
• Scientific title: GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures
• Date of first enrolment: September 28, 2016
• Target sample size: 47
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03462680
• 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 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



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

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Dietary Supplement: niacin

Other: placebo

Primary Outcome(s)

Stroop test change [Time Frame: at the baseline and after 6 months of intervention]

Niacin changes [Time Frame: at baseline and after 6 months]

Macrophage changes [Time Frame: at baseline and after 6 months]

Mini-Mental State Examination (MMSE) change [Time Frame: at baseline and after 6 months of treatment]

Unified Parkinson's Disease Rating Scale (UPDRS) change [Time Frame: at the recruitment and after 6 months]

Cerebrospinal Fluid (CSF) changes [Time Frame: at baseline and after 6 months]

Sleep test change [Time Frame: baseline and after 6 months]

Secondary ID(s)

N1613-I

Source(s) of Monetary Support

Please refer to primary and secondary sponsors