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

NCT03462680 | Completed Results

• 1 other identifier: N1613-I
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Inflammation plays a central role in Parkinson's disease. The use of anti-inflammatory drugs was found to reduce the risk of PD . Niacin may play an important role in reducing inflammation in PD. The investigators also found that individuals with PD have a chronic niacin deficiency . The purposes of this study are to (1) examine the blood, urine and spinal fluid of persons with Parkinson's to look for evidence of inflammation and; (2) whether 6 months of vitamin B3 supplements may reduce the inflammation and/or improve symptoms.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (8)

• Unified Parkinson's Disease Rating Scale (UPDRS) Change

  This is the Unified Parkinson's disease rating scale assessment. The investigators assess I, II, III and V components of the UPDRS. UPDRS 3 is motor skills. Higher scores mean worse outcome. A 0 is minimum and 120 is the maximum.

  at the recruitment and after 6 months

• REM Sleep Pattern

  This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the rapid eye movement (REM) sleep as a percentage.

  baseline and after 6 months

• Deep Sleep

  This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the deep sleep percentage.

  At baseline and after 6 months

• Light Sleep

  This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the light sleep percentage.

  baseline and 6 months

• Sleep Time - Awake

  This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the awake time during night sleep percentage.

  at baseline and 6 months

• Mini-Mental State Examination (MMSE) Change

  It captures mental status and awareness of time, place and surrounding. A zero is minimum and 30 is maximum. Higher score indicates better cognition.

  at baseline and after 6 months of treatment

• Stroop Test Change

  It captures understanding of color and its description within a certain time frame when letters and colors do not match. There are only two choices to pick from and the correct choices should be made to proceed to the next one. Correct choices are given one point and incorrect choices delete one point. Maximum number of correct choices per unit time are recorded. Three initial trials are given to understand the test. No minimum or maximum values. Higher numbers indicate better cognition.

  at the baseline and after 6 months of intervention

• Fatigue Severity Scale

  Fatigue was rated from 0-7 in a fatigue questionnaire. A 0 being the least and 7 being the highest level of fatigue.

  at baseline and after 6 months

Secondary Outcomes (28)

• Cerebrospinal Fluid Changes - Interleukin 6 (IL6)

  at baseline and after 6 months

• Cerebrospinal Fluid Changes - Interleukin 10 (IL-10)

  at baseline and after 6 months

• Niacin Metabolite in Urine - Niacin

  at baseline and after 6 months

• Niacin Metabolites in Urine - NAM Nicotinamide

  at baseline and 6 months

• Niacin Changes in Plasma - Niacin

  baseline and 6 months

Study Arms (2)

niacin

ACTIVE COMPARATOR

Niacin 250 mg is compared to placebo tablet.

Dietary Supplement: niacin

placebo

PLACEBO COMPARATOR

placebo

Other: placebo

Interventions

niacin DIETARY_SUPPLEMENT

Niacin or nicotinic acid 250 mg tablets

Also known as: vitamin B3

niacin

placebo OTHER

placebo tablet

placebo

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Charlie Norwood VA Medical Center, Augusta, GA

Augusta, Georgia, 30904, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Niacin; Niacinamide

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Additional studies are required including a larger cohort and multi-center to further generalize findings, as well as comparing niacin to placebo for longer than 6 months before optimal information can be obtained for use in clinical settings.

Results Point of Contact

• Title: Dr. Chandramohan Wakade
• Organization: Charlie Norwood VAMC

chandramohan.wakade@va.gov

706-733-0188

Study Officials

• Chandramohan Wakade, MBBS

  Charlie Norwood VA Medical Center, Augusta, GA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only Pharmacists keep the log of the drug dispensed. Everyone else is blinded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: There are two arms, niacin and placebo. They are double blind and randomized.

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 12, 2018
• Study Start: September 28, 2016
• Primary Completion: April 23, 2020
• Study Completion: April 23, 2020
• Last Updated: November 17, 2021
• Results First Posted: November 17, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: One year after the study is closed.
• Access Criteria: When we are ready to publish, the data will be available.

Locations

US (1)