Cognitive ImpairmentNCT05500170
Benefits of Nicotinamide Riboside Upon Cognition and Sleep
A study testing Nicotinamide riboside in people with Cognitive Impairment and Sleep Quality, run by State University of New York at Buffalo at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Sleep Quality
- What is being tested?
- Nicotinamide riboside
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Apr 2023to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Sleep Quality. Pittsburgh Sleep Quality Index (PSQI) global score >5
Who cannot join
- Dementia. Veteran Affairs - St. Louis University Mental Status questionnaire (VA-SLUMS) score <20
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
State University of New York at Buffalo
Buffalo, New York, 14203
Carleara Weiss, PhD, MS, RN
- Not yet recruiting
University at Buffalo State University of New York
Buffalo, New York, 14203
Carleara Weiss, PhD, MS, RN, 716-829-2006, carleara@buffalo.edu
- Recruiting
Buffalo Veteran Affairs Medical Center
Buffalo, New York, 14215
Carleara Weiss, PhD
About this study
Official title: The Benefits of Nicotinamide Riboside Upon Cognition and Sleep in Older Veterans
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.
Read the 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
- Being tested
- Nicotinamide riboside, Placebo
- Medical subject headings
- Cognitive Dysfunction, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide ribosideDietary supplement
Also called NR, vitamin B3
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.
PlaceboDietary supplement
Also called Placebo pill
The placebo pill will contain micro cellulose powder.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in the intervention group will receive 500mg of NR twice daily Receives: Dietary Supplement: Nicotinamide riboside |
| Placebo | Placebo comparator | Participants in the intervention group will receive 500mg of sham placebo twice daily Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to endpoint at 12 weeks
Secondary outcomes (1)
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.
Measured: Change from baseline to endpoint at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start4 Apr 2023
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A clinical trial, randomized controlled trial, double-blinded. Participants will be assigned to intervention (NR supplementation) or placebo groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carleara Weiss, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500170
- Sponsor's protocol ID
- FP00006694
- Status last verified
- Sep 2026
- First submitted
- 9 Aug 2022
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All clinical information obtained from the participants will be contained in a password-protected secure database that has been designed specifically for the current research proposal. Published or reported results from this trial will not contain any personal information that could be linked to individuals. The data will be monitored routinely to maintain safety and productivity, as well as to assist with research dissemination annually.
Publications
Zhang SQ, Lee J, Pan JP, Enger R, Hrubos-Strom H, Musiek ES, Fang EF, Le W. NAD+-circadian rhythm coupling in dementia. Alzheimers Dement. 2026 May;22(5):e71360. doi: 10.1002/alz.71360.
PubMed 42063312
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits of Nicotinamide Riboside Upon Cognition and Sleep in Older Veterans
- ClinicalTrials.gov ID
- NCT05500170
- Acronym / sponsor ID
- FP00006694
- Conditions
- Cognitive Impairment, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A clinical trial, randomized controlled trial, double-blinded. Participants will be assigned to intervention (NR supplementation) or placebo groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Nicotinamide ribosideParticipants in the intervention group will receive 500mg of NR twice daily |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants in the intervention group will receive 500mg of sham placebo twice daily |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Sleep Quality. Pittsburgh Sleep Quality Index (PSQI) global score >5
Key exclusion criteria (1 listed)
- Dementia. Veteran Affairs - St. Louis University Mental Status questionnaire (VA-SLUMS) score <20
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotinamide ribosideAlso: NR, vitamin B3Nicotinamide 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. | Dietary supplement | Intervention |
| PlaceboAlso: Placebo pillThe placebo pill will contain micro cellulose powder. | Dietary supplement | Placebo |
Primary outcome
Sleep Quality Assessment
Time frame: Change from baseline to endpoint at 12 weeks
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.
1 secondary outcome
Cognitive function
Time frame: Change from baseline to endpoint at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Derived from this study: PubMed 42063312Zhang SQ, Lee J, Pan JP, Enger R, Hrubos-Strom H, Musiek ES, Fang EF, Le W. NAD+-circadian rhythm coupling in dementia. Alzheimers Dement. 2026 May;22(5):e71360. doi: 10.1002/alz.71360.
- Individual participant dataSharing planned: Yes. All clinical information obtained from the participants will be contained in a password-protected secure database that has been designed specifically for the current research proposal. Published or reported results from this trial will not contain any personal information that could be linked to individuals. The data will be monitored routinely to maintain safety and productivity, as well as to assist with research dissemination annually.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotinamide riboside in people with Cognitive Impairment and Sleep Quality, run by State University of New York at Buffalo at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carleara Weiss, PhD, MS, RN (7168282006, carleara@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality Assessment (time frame: Change from baseline to endpoint at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05500170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.