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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05500170
Other study ID # FP00006694
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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