Benefits of Nicotinamide Riboside Upon Cognition and Sleep

Cognitive Impairment Clinical Trial

Official title:

The Benefits of Nicotinamide Riboside Upon Cognition and Sleep in Older Veterans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05500170
• Other study ID #: FP00006694
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: September 2023
• Source: State University of New York at Buffalo
• Contact: Carleara Weiss, PhD, MS, RN
• Phone: 7168282006
• Email: carleara[@]buffalo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Poor sleep quality and short sleep duration may be a mechanistic component of cognitive impairment in older adults, associated with a decline in brain-derived neurotrophic factor. Increasing the availability of nicotinamide adenine dinucleotide (NAD+) with supplementation of its precursor, nicotinamide riboside (NR), a form of vitamin B3 may increase the expression of brain-derived neurotrophic factor. This study proposes to examine the benefits of NR supplementation on sleep and cognitive function in older adults with comprehensive subjective and objective measures and to explore its impacts on serum brain-derived neurotrophic factor.

Description:

Ten percent of adults aged ≥ 65 years and fifty percent of adults ≥ 85 years exhibit cognitive impairment. Dementia treatment cost $277 billion in 2018 and is predicted to surpass $500 billion with the aged population reaching 70 million by 2030 in America. In addition, 50% of older adults experience poor sleep quality, including fragmented nighttime sleep, reduced sleep efficiency, and earlier bedtime and wake-up times. Consequently, millions of Americans are at risk for both cognitive impairment, including Alzheimer's Disease and other dementias, and disrupted sleep. Sleep disruptions alter underlying circadian rhythms and synaptic plasticity in the hippocampus, as well as reduce expression of brain-derived neurotrophic factor (BDNF) - elements associated with impaired memory, dementia, and Alzheimer's Disease. Importantly, sleep disturbances and mild cognitive impairment may appear several years before the development of clinical dementia. Therefore, interventions that improve sleep may prevent cognitive impairment and would have substantial clinical importance. Pre-clinical animal models suggest that enhancing the availability of nicotinamide adenine dinucleotide (NAD+) may reduce cognitive decline and support sleep quality by boosting mitochondrial function and BDNF expression. Additionally, supplementation with NAD+ precursor nicotinamide riboside (NR), a form of vitamin B3, improves cognition in aged mice. The hypothesis for this study is that NR supplementation will enhance cognition by improving objective sleep duration and sleep quality in older persons. To test the hypothesis, this study will measure the benefits of NR supplementation on sleep and cognition in older Veterans and determine the role of BNDF as a potential biomarker of sleep quality.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Sleep Quality

Intervention

Dietary Supplement:
• Nicotinamide riboside
Nicotinamide riboside (NR) is a form of vitamin B3, which is found in fruits, vegetables, meat, and milk. NR is converted into nicotinamide adenosine dinucleotide NAD+. Low NAD+ levels have been linked to Alzheimer's disease and sleep disturbances.
• Placebo
The placebo pill will contain micro cellulose powder.

Locations

Country	Name	City	State
United States	Buffalo Veteran Affairs Medical Center	Buffalo	New York
United States	State University of New York at Buffalo	Buffalo	New York
United States	University at Buffalo State University of New York	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarkers	Assessment of serum levels of BDNF, NfL, Aß42/Aß40 ratio, and p-tau as potential markers of cognition and sleep	Change from baseline to endpoint at 12 weeks
Primary	Sleep Quality Assessment	Sleep quality will be assessed with the Pittsburgh Sleep Quality Index , where global score >5 indicates poor sleep quality and global score <5 indicates good sleep quality.	Change from baseline to endpoint at 12 weeks
Secondary	Cognitive function	Cognitive function will be assessed with the Veterans Affairs St. Louis University Mental Health Status (VA-SLUMS), which contains 11 items designed to measure orientation, memory, attention, and executive function. Scores range from 0-30 with categories of unimpaired, mildly impaired, and impaired.	Change from baseline to endpoint at 12 weeks