Trial Outcomes & Findings for Crossover Trial for Nicotinamide Riboside in Subjective Cognitive Decline and Mild Cognitive Impairment (NCT NCT04078178)
NCT ID: NCT04078178
Last Updated: 2024-11-29
Results Overview
The primary outcome of this study will be objective measures of cognitive performance measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at baseline, crossover, and the end of study. RBANS has a mean score of 100 with a standard deviation of 15. Scores range from 40 to 160. Higher scores indicate normal cognition.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
From baseline through end of study at 16 weeks
Results posted on
2024-11-29
Participant Flow
61 Participants signed consent and enrolled in the study. Prior to randomization assignment, 15 participants screen failed. 46 proceeded to randomization assignment and study lead-in.
Participant milestones
| Measure |
Sequence 1: Niagen, Then Placebo
Subjects received 1000 mg Niagen daily for 8 weeks. After 8 weeks of Niagen, participants took Placebo daily for 8 weeks.
Niagen: Nicotinamide Riboside
|
Sequence 2: Placebo, Then Niagen
Subjects received Placebo daily for 8 weeks, then participants received 1000mg Active Niagen daily for 8 weeks.
Niagen: Nicotinamide Riboside
|
|---|---|---|
|
Lead-In Period (4-Weeks)
STARTED
|
23
|
23
|
|
Lead-In Period (4-Weeks)
COMPLETED
|
22
|
20
|
|
Lead-In Period (4-Weeks)
NOT COMPLETED
|
1
|
3
|
|
Baseline/Initial Treatment (8 Weeks)
STARTED
|
22
|
20
|
|
Baseline/Initial Treatment (8 Weeks)
COMPLETED
|
20
|
18
|
|
Baseline/Initial Treatment (8 Weeks)
NOT COMPLETED
|
2
|
2
|
|
Crossover Treatment (8 Weeks)
STARTED
|
20
|
18
|
|
Crossover Treatment (8 Weeks)
COMPLETED
|
20
|
17
|
|
Crossover Treatment (8 Weeks)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Sequence 1: Niagen, Then Placebo
Subjects received 1000 mg Niagen daily for 8 weeks. After 8 weeks of Niagen, participants took Placebo daily for 8 weeks.
Niagen: Nicotinamide Riboside
|
Sequence 2: Placebo, Then Niagen
Subjects received Placebo daily for 8 weeks, then participants received 1000mg Active Niagen daily for 8 weeks.
Niagen: Nicotinamide Riboside
|
|---|---|---|
|
Lead-In Period (4-Weeks)
Withdrawal by Subject
|
0
|
1
|
|
Lead-In Period (4-Weeks)
Screen Fail
|
1
|
2
|
|
Baseline/Initial Treatment (8 Weeks)
Withdrawal by Subject
|
1
|
2
|
|
Baseline/Initial Treatment (8 Weeks)
Early Termination
|
1
|
0
|
|
Crossover Treatment (8 Weeks)
Early Termination
|
0
|
1
|
Baseline Characteristics
Crossover Trial for Nicotinamide Riboside in Subjective Cognitive Decline and Mild Cognitive Impairment
Baseline characteristics by cohort
| Measure |
Sequence 1: Active Niagen, Placebo
n=23 Participants
Subjects received 1000 mg Niagen and PBO dispensed in randomized blocks. Participants in Sequence 1 took Niagen daily for 8 weeks, followed by Placebo daily for 8 weeks.
Niagen: Nicotinamide Riboside
Placebo Comparator: Placebo
|
Sequence 2: Placebo, Active Niagen
n=23 Participants
Subjects received 1000 mg Niagen and PBO dispensed in randomized blocks. Participants in Sequence 2 took Placebo daily for 8 weeks, followed by Active Niagen daily for 8 weeks.
Niagen: Nicotinamide Riboside
Placebo Comparator: Placebo
|
Total
n=46 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
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline through end of study at 16 weeksPopulation: Participants that completed the trial were analyzed (20 in sequence 1; 17 in sequence 2)
The primary outcome of this study will be objective measures of cognitive performance measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at baseline, crossover, and the end of study. RBANS has a mean score of 100 with a standard deviation of 15. Scores range from 40 to 160. Higher scores indicate normal cognition.
Outcome measures
| Measure |
Sequence 1: Active Niagen, Placebo
n=20 Participants
Subjects received 1000 mg Niagen and PBO dispensed in randomized blocks. Participants in Sequence 1 took Niagen daily for 8 weeks, followed by Placebo daily for 8 weeks.
Niagen: Nicotinamide Riboside
Placebo Comparator: Placebo
|
Sequence 2: Placebo, Active Niagen
n=17 Participants
Subjects received 1000 mg Niagen and PBO dispensed in randomized blocks. Participants in Sequence 2 took Placebo daily for 8 weeks, followed by Active Niagen daily for 8 weeks.
Niagen: Nicotinamide Riboside
Placebo Comparator: Placebo
|
|---|---|---|
|
The Effect of Niagen vs PBO on Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
Baseline
|
92.15 units on a scale
Standard Error 2.68
|
91.04 units on a scale
Standard Error 3.15
|
|
The Effect of Niagen vs PBO on Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
1st intervention/crossover 8 weeks
|
94.87 units on a scale
Standard Error 2.68
|
95.17 units on a scale
Standard Error 3.16
|
|
The Effect of Niagen vs PBO on Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
16 weeks/end of study
|
93 units on a scale
Standard Error 3.1
|
95.64 units on a scale
Standard Error 3.58
|
Adverse Events
Sequence 1: Baseline (Niagen)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sequence 1: Crossover (Placebo)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sequence 2: Baseline (Placebo)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Sequence 2: Crossover (Niagen)
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sequence 1: Baseline (Niagen)
n=22 participants at risk
Subjects received 1000 mg Niagen and PBO dispensed in randomized blocks. Participants in Sequence 1 took Niagen daily for 8 weeks, followed by Placebo daily for 8 weeks.
Niagen: Nicotinamide Riboside
Placebo Comparator: Placebo
|
Sequence 1: Crossover (Placebo)
n=20 participants at risk
Subjects received 1000 mg Niagen and PBO dispensed in randomized blocks. Participants in Sequence 1 took Niagen daily for 8 weeks, followed by Placebo daily for 8 weeks.
Niagen: Nicotinamide Riboside
Placebo Comparator: Placebo
|
Sequence 2: Baseline (Placebo)
n=20 participants at risk
Subjects received 1000 mg Niagen and PBO dispensed in randomized blocks. Participants in Sequence 2 took Placebo daily for 8 weeks, followed by Active Niagen daily for 8 weeks.
Niagen: Nicotinamide Riboside
Placebo Comparator: Placebo
|
Sequence 2: Crossover (Niagen)
n=18 participants at risk
Subjects received 1000 mg Niagen and PBO dispensed in randomized blocks. Participants in Sequence 2 took Placebo daily for 8 weeks, followed by Active Niagen daily for 8 weeks.
Niagen: Nicotinamide Riboside
Placebo Comparator: Placebo
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/22 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
0.00%
0/20 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
0.00%
0/20 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
|
Musculoskeletal and connective tissue disorders
Fall
|
0.00%
0/22 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
0.00%
0/20 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
0.00%
0/18 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
|
Renal and urinary disorders
UTI
|
0.00%
0/22 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
0.00%
0/20 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
0.00%
0/20 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
Other adverse events
| Measure |
Sequence 1: Baseline (Niagen)
n=22 participants at risk
Subjects received 1000 mg Niagen and PBO dispensed in randomized blocks. Participants in Sequence 1 took Niagen daily for 8 weeks, followed by Placebo daily for 8 weeks.
Niagen: Nicotinamide Riboside
Placebo Comparator: Placebo
|
Sequence 1: Crossover (Placebo)
n=20 participants at risk
Subjects received 1000 mg Niagen and PBO dispensed in randomized blocks. Participants in Sequence 1 took Niagen daily for 8 weeks, followed by Placebo daily for 8 weeks.
Niagen: Nicotinamide Riboside
Placebo Comparator: Placebo
|
Sequence 2: Baseline (Placebo)
n=20 participants at risk
Subjects received 1000 mg Niagen and PBO dispensed in randomized blocks. Participants in Sequence 2 took Placebo daily for 8 weeks, followed by Active Niagen daily for 8 weeks.
Niagen: Nicotinamide Riboside
Placebo Comparator: Placebo
|
Sequence 2: Crossover (Niagen)
n=18 participants at risk
Subjects received 1000 mg Niagen and PBO dispensed in randomized blocks. Participants in Sequence 2 took Placebo daily for 8 weeks, followed by Active Niagen daily for 8 weeks.
Niagen: Nicotinamide Riboside
Placebo Comparator: Placebo
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
4.5%
1/22 • Number of events 1 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
0.00%
0/20 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
0.00%
0/18 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
|
Musculoskeletal and connective tissue disorders
Cramping
|
9.1%
2/22 • Number of events 2 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
5.0%
1/20 • Number of events 2 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
15.0%
3/20 • Number of events 4 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected for each participant from the baseline visit to end of study, 20 weeks. In the NR-Placebo group (Sequence 1), there were 22 participants that started Baseline, with 2 withdrawing/Early Termination before crossover. In the Placebo- NR group (Sequence 2), there were 20 participants that started baseline (Placebo) and then 18 who crossed over into the NR group. Data was collected for 22 participants in Sequence 1 and 20 participants in Sequence 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place