Benefits of Nicotinamide Riboside Upon Cognition and Sleep

NCT ID: NCT05500170

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-04
• Study Completion Date: 2027-08-30

Brief 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.

Detailed 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.

Conditions

Cognitive Impairment; Sleep Quality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Nicotinamide riboside

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

The placebo pill will contain micro cellulose powder.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The placebo pill will contain micro cellulose powder.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

NR, vitamin B3; Placebo pill

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Carleara Weiss

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

State University of New York at Buffalo

Buffalo, New York, United States

Site Status: NOT_YET_RECRUITING

University at Buffalo State University of New York

Buffalo, New York, United States

Site Status: NOT_YET_RECRUITING

Buffalo Veteran Affairs Medical Center

Buffalo, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carleara Weiss, PhD, MS, RN

Role: CONTACT

carleara@buffalo.edu

7168282006

Rebecca A Lorenz, PhD, RN

Role: CONTACT

rlorenz@buffalo.edu

716-829-2204

Facility Contacts

Carleara Weiss, PhD, MS, RN

Role: primary

Carleara Weiss, PhD, MS, RN

Role: primary

carleara@buffalo.edu

716-829-2006

Carleara Weiss, PhD

Role: primary

Other Identifiers

FP00006694

Identifier Type: -

Identifier Source: org_study_id