Nicotinamide Riboside for Cognitive Impairment and Sleep Quality

Recruiting at 2 trial locations

Overseen By Carleara Weiss, PhD, MS, RN

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Dementia

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether nicotinamide riboside (NR), a form of vitamin B3, can improve sleep and brain function in older adults. Poor sleep often leads to concentration and memory issues, and NR might help by boosting a brain chemical that supports these functions. Participants will take either NR or a placebo (an inactive substance) to determine any differences in sleep and cognitive abilities. Ideal participants have trouble sleeping, indicated by a sleep quality score above 5 on a common sleep questionnaire. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on sleep and cognitive health.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that nicotinamide riboside (NR) is generally safe and well-tolerated as a supplement. Studies have found that NR increases levels of NAD+, a molecule crucial for cell energy, in adults. Most people taking NR experience only mild side effects, such as an upset stomach. NR is considered safe at doses up to 300mg per day, but this trial tests higher doses. This suggests that NR might be a safe option for improving sleep and brain function, but it is always important to follow the study team's guidance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for cognitive impairment and sleep disorders, which often involve pharmaceuticals that target neurotransmitters, Nicotinamide Riboside (NR) is a form of vitamin B3 that aims to enhance cellular energy production. Researchers are excited about NR because it works by boosting levels of NAD+, a molecule vital for cellular metabolism and repair, potentially offering a more natural approach to improving brain function and sleep quality. This mechanism is distinct because it supports the body's own processes rather than altering brain chemistry directly, which may lead to fewer side effects and a broader range of benefits.

What evidence suggests that nicotinamide riboside might be an effective treatment for cognitive impairment and sleep quality?

This trial will evaluate the effects of nicotinamide riboside (NR), a type of vitamin B3, on cognitive impairment and sleep quality. Research has shown that NR might improve brain function and sleep in older adults. Studies have found that NR can boost learning and memory and may even help with brain issues related to Alzheimer's disease. Animal research suggests that NR can assist with memory problems in older mice and those with Alzheimer's. This effect is believed to occur because NR increases a substance called NAD+, which is important for a healthy brain. While research on humans is ongoing, early results are promising for NR as a potential aid for better sleep and clearer thinking. Participants in this trial will receive either NR or a placebo to assess its effectiveness. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for older adults who have trouble sleeping and may be experiencing some cognitive challenges. To join, they need to score more than 5 on a sleep quality test but can't have dementia as indicated by scoring less than 20 on a mental status questionnaire.

Inclusion Criteria

Sleep Quality. Pittsburgh Sleep Quality Index (PSQI) global score >5

Exclusion Criteria

Dementia. Veteran Affairs - St. Louis University Mental Status questionnaire (VA-SLUMS) score <20

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 500mg of nicotinamide riboside or placebo twice daily

12 weeks

Regular visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nicotinamide Riboside
• Placebo

Trial Overview

The study is testing whether taking Nicotinamide Riboside (NR), a vitamin B3 form, improves sleep and brain function in older adults. Participants will either receive NR or a placebo without active ingredients to compare the effects.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants in the intervention group will receive 500mg of NR twice daily

Group II: Placebo Placebo Group 1 Intervention

Participants in the intervention group will receive 500mg of sham placebo twice daily

Nicotinamide Riboside is already approved in United States, European Union for the following indications:

Approved in United States as Niagen for:

• Dietary supplement for general health and wellness

Approved in European Union as Niagen for:

• Dietary supplement for general health and wellness

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Published Research Related to This Trial

Nicotinamide riboside (NR) is a promising NAD+ precursor that has shown potential health benefits in treating various conditions, including cardiovascular, neurodegenerative, and metabolic disorders, based on numerous animal and human studies.

Research indicates that NR may also have therapeutic applications against infections, such as SARS-CoV-2, but challenges related to its bioavailability and safety need to be addressed for effective translation into clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotinamide Riboside-The Current State of Research and Therapeutic Uses. Mehmel, M., Jovanović, N., Spitz, U.[2021]

Oral supplementation with nicotinamide riboside has shown potential in improving learning and memory while reducing Alzheimer's disease-related pathology in mouse models, indicating its efficacy in combating age-related cognitive decline.

Nicotinamide riboside is well tolerated in humans with minimal side effects, suggesting it could be a safe therapeutic option for enhancing cognitive function and maintaining brain health as we age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can nicotinamide riboside protect against cognitive impairment? Braidy, N., Liu, Y.[2021]

Nicotinamide riboside (NR) is a form of vitamin B3 that effectively increases NAD+ levels, which may help counteract age-related declines in this important metabolite.

In a 90-day safety study on Sprague Dawley rats, NR-E showed no significant adverse effects at doses up to 1,200 mg/kg/d, establishing a no-observed-adverse-effect-level (NOAEL) of 500 mg/kg/d for males and 1,200 mg/kg/d for females.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Assessment of High-Purity, Synthetic Nicotinamide Riboside (NR-E) in a 90-Day Repeated Dose Oral Toxicity Study, With a 28-Day Recovery Arm. Marinescu, AG., Chen, J., Holmes, HE., et al.[2021]

A study involving 108 older adults showed that taking nicotinamide mononucleotide (NMN) in the afternoon significantly improved lower limb function and reduced drowsiness after 12 weeks.

The NMN group demonstrated the largest improvements in physical performance, particularly in the 5-times sit-to-stand test, indicating its potential to enhance physical capabilities and combat fatigue in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 12-Week Intake of Nicotinamide Mononucleotide on Sleep Quality, Fatigue, and Physical Performance in Older Japanese Adults: A Randomized, Double-Blind Placebo-Controlled Study. Kim, M., Seol, J., Sato, T., et al.[2022]

Nicotinamide riboside (NR) was safely administered to 20 older adults with mild cognitive impairment (MCI) over a 10-week period, resulting in a significant 2.6-fold increase in blood NAD+ levels without any adverse effects reported between the NR and placebo groups.

While NR treatment did not improve cognitive function as measured by the Montreal Cognitive Assessment (MoCA), it did lead to a reduction in cerebral blood flow in specific brain regions, indicating that further research is needed to explore its potential effects on cognition and brain health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized placebo-controlled trial of nicotinamide riboside in older adults with mild cognitive impairment. Orr, ME., Kotkowski, E., Ramirez, P., et al.[2023]

In an 8-week clinical trial with overweight but healthy participants, nicotinamide riboside (NR) significantly increased whole blood NAD+ levels in a dose-dependent manner, with increases of 22%, 51%, and 142% for doses of 100, 300, and 1000 mg, respectively.

The study found NR to be safe, with no significant adverse effects reported compared to placebo, and it did not negatively impact cholesterol levels or 1-carbon metabolism, supporting its potential as a dietary supplement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Metabolism of Long-term Administration of NIAGEN (Nicotinamide Riboside Chloride) in a Randomized, Double-Blind, Placebo-controlled Clinical Trial of Healthy Overweight Adults. Conze, D., Brenner, C., Kruger, CL.[2023]

Nicotinamide ribose (NR) supplementation for 3 months improved cognitive functions, such as short-term spatial memory in aged mice and contextual fear memory in Alzheimer's disease (AD) model mice, indicating its potential efficacy in combating cognitive decline.

NR supplementation also reduced harmful effects associated with AD, such as the accumulation of amyloid-beta (Aβ) and the activation of astrocytes, suggesting a mechanism of action that may help prevent the progression of dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotinamide ribose ameliorates cognitive impairment of aged and Alzheimer's disease model mice. Xie, X., Gao, Y., Zeng, M., et al.[2022]

A 7-day supplementation with RiaGev, a combination of nicotinamide and D-ribose, significantly increased NAD+ levels in healthy middle-aged adults, particularly boosting NADP+ by 27% compared to placebo, indicating its efficacy in enhancing the NAD metabolome.

Participants taking RiaGev reported reduced fatigue and improved mental concentration, with no significant adverse effects observed, suggesting that it is a safe option for enhancing energy metabolism and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Combination of Nicotinamide and D-Ribose (RiaGev) Is Safe and Effective to Increase NAD+ Metabolome in Healthy Middle-Aged Adults: A Randomized, Triple-Blind, Placebo-Controlled, Cross-Over Pilot Clinical Trial. Xue, Y., Shamp, T., Nagana Gowda, GA., et al.[2022]

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