Trial Outcomes & Findings for Low Dose Niacin (Vitamin B3) for Parkinson's Disease (NCT NCT03808961)

Last Updated: 2025-03-04

Results Overview

It captures mental status and awareness of time, place and surrounding. Score ranges from 0-30, 30 denotes the best score and best mental status. All the values in the group are pooled for an average score at baseline, 6 months, 12 months, and 18 months. Therefore, Niacin and Niacinamide groups each demonstrates average of 8 values while placebo group shows average of 12 values.

Recruitment status

TERMINATED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

Baseline, 6 month, 12 month and 18 months

Results posted on

2025-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 - Niacin Arm Oral 100 mg fixed dose twice daily x 18-months (200 mg total / day) with assessments @ baseline, 6 month, 12 month and 18 months Niacin: 100mg tablets twice daily	Group 2 - Niacinamide Arm Oral 100 mg fixed dose twice daily (200 mg total / day) x 18-months with assessments @ baseline, 6 month, 12 month and 18 months Niacinamide: 100mg tablets twice daily	Group 3 - Placebo Wait-listed Arm Oral placebo twice daily x 18- months with assessments @ baseline, 6 month, 12 month and 18 months Placebo: Placebo tablet twice daily
Overall Study STARTED	2	2	3
Overall Study COMPLETED	2	2	3
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low Dose Niacin (Vitamin B3) for Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 - Niacin Arm n=2 Participants Oral 100 mg fixed dose twice daily x 18-months (200 mg total / day) with assessments @ baseline, 6 month, 12 month and 18 months Niacin: 100mg tablets twice daily	Group 2 - Niacinamide Arm n=2 Participants Oral 100 mg fixed dose twice daily (200 mg total / day) x 18-months with assessments @ baseline, 6 month, 12 month and 18 months Niacinamide: 100mg tablets twice daily	Group 3 - Placebo Wait-listed Arm n=3 Participants Oral placebo twice daily x 18- months with assessments @ baseline, 6 month, 12 month and 18 months Placebo: Placebo tablet twice daily	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Age, Continuous	62 years STANDARD_DEVIATION 8 • n=5 Participants	67.5 years STANDARD_DEVIATION 3.5 • n=7 Participants	69.33 years STANDARD_DEVIATION 2.5 • n=5 Participants	66.27 years STANDARD_DEVIATION 3 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
UPDRS III	40.5 units on a scale. STANDARD_DEVIATION 9 • n=5 Participants	20.5 units on a scale. STANDARD_DEVIATION 4 • n=7 Participants	17.6 units on a scale. STANDARD_DEVIATION 8 • n=5 Participants	26.2 units on a scale. STANDARD_DEVIATION 12 • n=4 Participants
Mini Mental examination	30 units on a scale STANDARD_DEVIATION 0 • n=5 Participants	28.5 units on a scale STANDARD_DEVIATION 2.5 • n=7 Participants	30 units on a scale STANDARD_DEVIATION 0 • n=5 Participants	29.5 units on a scale STANDARD_DEVIATION 0.5 • n=4 Participants
Visual Analogue Fatigue Score	6.5 score on a scale STANDARD_DEVIATION 0.5 • n=5 Participants	5.5 score on a scale STANDARD_DEVIATION 0.5 • n=7 Participants	7 score on a scale STANDARD_DEVIATION 3 • n=5 Participants	6.3 score on a scale STANDARD_DEVIATION 1.2 • n=4 Participants
step score	20.4 seconds STANDARD_DEVIATION 0.4 • n=5 Participants	13 seconds STANDARD_DEVIATION 2 • n=7 Participants	10.4 seconds STANDARD_DEVIATION 2.2 • n=5 Participants	14.6 seconds STANDARD_DEVIATION 4 • n=4 Participants
Trail making A	35.5 seconds STANDARD_DEVIATION 5.5 • n=5 Participants	72.5 seconds STANDARD_DEVIATION 31.5 • n=7 Participants	49.33 seconds STANDARD_DEVIATION 21 • n=5 Participants	52.44 seconds STANDARD_DEVIATION 18.69 • n=4 Participants
Trail making B	81.5 seconds STANDARD_DEVIATION 9 • n=5 Participants	150.5 seconds STANDARD_DEVIATION 65.5 • n=7 Participants	198 seconds STANDARD_DEVIATION 203.22 • n=5 Participants	143.33 seconds STANDARD_DEVIATION 58.57 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 6 month, 12 month and 18 months

This is the Unified Parkinson's disease rating scale assessment. The investigators assess part III of the UPDRS regarding motor skills. The values reported are the averages of baseline, 6months, 12 months, and 18 months values combined for all the participants in that group. So, in the niacin and the niacinamide groups, it indicated the average of 8 values and in the control group it is the average of 12 values. A score is recorded according to the motor skills recorded ranging from 0-5 in each test, 0 being normal and 5 being affected most. Scores are given judging the motor skills. The score may range between 0-132. Lower scores indicate better outcome.

Outcome measures

Outcome measures
Measure	Group 1 - Niacin Arm n=2 Participants Oral 100 mg fixed dose twice daily x 18-months (200 mg total / day) with assessments @ baseline, 6 month, 12 month and 18 months Niacin: 100mg tablets twice daily	Group 2 - Niacinamide Arm n=2 Participants Oral 100 mg fixed dose twice daily (200 mg total / day) x 18-months with assessments @ baseline, 6 month, 12 month and 18 months Niacinamide: 100mg tablets twice daily	Group 3 - Placebo Wait-listed Arm n=3 Participants Oral placebo twice daily x 18- months with assessments @ baseline, 6 month, 12 month and 18 months Placebo: Placebo tablet twice daily
Unified Parkinson's Disease Rating Scale (UPDRS) Change	40.5 score on a scale Standard Deviation 10	20.5 score on a scale Standard Deviation 2.5	17.5 score on a scale Standard Deviation 12

PRIMARY outcome

Timeframe: Baseline, 6 month, 12 month and 18 months

Outcome measures

Outcome measures
Measure	Group 1 - Niacin Arm n=2 Participants Oral 100 mg fixed dose twice daily x 18-months (200 mg total / day) with assessments @ baseline, 6 month, 12 month and 18 months Niacin: 100mg tablets twice daily	Group 2 - Niacinamide Arm n=2 Participants Oral 100 mg fixed dose twice daily (200 mg total / day) x 18-months with assessments @ baseline, 6 month, 12 month and 18 months Niacinamide: 100mg tablets twice daily	Group 3 - Placebo Wait-listed Arm n=3 Participants Oral placebo twice daily x 18- months with assessments @ baseline, 6 month, 12 month and 18 months Placebo: Placebo tablet twice daily
Mini-Mental State Examination (MMSE) Change	29.57 score on a scale Standard Deviation 1.04	29.4 score on a scale Standard Deviation 1.2	30 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline, 6 month, 12 month and 18 months

Fatigue is self-reported on the Visual analogue fatigue scale (VAFS). Participants were asked about how much fatigue they feel ranging from no fatigue (score 0) to extreme fatigue (score 10). Each participant was asked about this score at baseline, 6 months, 12 months, and 18 months visit. Data reported is the averages of all the scores from that group for all the time points.

Outcome measures

Outcome measures
Measure	Group 1 - Niacin Arm n=2 Participants Oral 100 mg fixed dose twice daily x 18-months (200 mg total / day) with assessments @ baseline, 6 month, 12 month and 18 months Niacin: 100mg tablets twice daily	Group 2 - Niacinamide Arm n=2 Participants Oral 100 mg fixed dose twice daily (200 mg total / day) x 18-months with assessments @ baseline, 6 month, 12 month and 18 months Niacinamide: 100mg tablets twice daily	Group 3 - Placebo Wait-listed Arm n=3 Participants Oral placebo twice daily x 18- months with assessments @ baseline, 6 month, 12 month and 18 months Placebo: Placebo tablet twice daily
Visual Analogue Fatigue Scale Changes	5.75 score on a scale Standard Deviation 1.5	5.75 score on a scale Standard Deviation 1.5	8.8 score on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: Baseline, 6 month, 12 month and 18 months

This is a timed test where the patient connects numbers in order for part A. Numbers and letters are connected interchangeably in past B. The time of B minus the time of A gives a measure for set shift change ability which is reduced in Parkinson's patients. Each A and B demonstrates averages from baseline, 6 months, 12 months and 18 months of all the participants. Therefore, in the niacin group A and group B each show averages of 8 values while the control group shows averages of 12 values.

Outcome measures

Outcome data not reported

Adverse Events

Group 1 - Niacin Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2 - Niacinamide Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 3 - Placebo Wait-listed Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chandramohan Wakade

VAORD

Phone: 7067211106

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place