Alzheimer DiseaseEmerald-NRADNCT05245903
Passive Sensor Identification of Digital Biomarkers to Assess Effects of Orally Administered Nicotinamide Riboside
An observational study of Alzheimer Disease and Dementia Alzheimers, run by Mclean Hospital at 1 site in United States.
Trial summary
This project's main goal is to use state-of-the-art passive sensing techniques to identify digital biomarkers that relate to bioenergetic changes in the brain due to nicotinamide riboside supplementation in those with mild cognitive impairment and mild Alzheimer's dementia. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Alzheimer Disease, Dementia Alzheimers, Dementia
- What is being tested?
- Emerald Device Monitoring
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2022to 31 May 2026
- Phase
- Observational
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from the existing pool of study subjects for the parent study (MGB IRB protocol #2020P001652, ClinicalTrials.gov identifier NCT04430517). Participation in this supplemental portion of the parent study will be elective for study subjects. Separate informed consent for the installation of the Emerald device will be used, and recruitment for this study will run concurrently with the parent project (IRB protocol #2020P001652, ClinicalTrials.gov identifier NCT04430517). All consented individuals will be targeted for supplemental recruitment for this project.
Who may be able to join
- Ability of the participant and/or his/her legally authorized representative to understand the purpose and risks of the study, to provide signed and dated informed consent, and to authorize the use of confidential health information.
- Ability to speak and read fluently in English
- 18-89 years old (inclusive)
- Normal or corrected to normal hearing and vision
- Meet clinical diagnostic criteria for MCI or Mild AD, according to the criteria outlined above
- Study partner available for duration of trial participation
Show all 9Show fewer
- At least one copy of the APOE ε4 allele
- An aggregate risk score > 4 according to the risk analysis method developed by Sabbagh et al. (2017)
- For individuals who are taking niacin (or a vitamin supplement with niacin) of >200mg, the completion of a two-week wash-out period
Who cannot join
- Current serious or unstable medical or neurological condition that could affect cognitive functioning, as determined by study clinician
- Clinically unstable mood or anxiety disorder within 6 months prior to screening, as determined by study clinician
- Lifetime history of psychotic disorder (i.e. Schizophrenia, Schizoaffective Disorder), as determined by study clinician
- Diagnosis of a mitochondrial disorder
- Any MRI safety contraindications
- History of drug hypersensitivity or intolerance to NR
Show all 18Show fewer
- Transient ischemic attack or stroke within 1 year prior to screening
- History of alcohol or substance abuse within prior year, as determined by study clinician and urine toxicology screen
- History of head injury rated as moderate or worse, per DSM-5 criteria
- History of seizure within prior 10 years
- Current use of medication with known adverse effects on cognition (benzodiazepines, barbiturates, opiate analgesics, first generation antipsychotic medication, anticholinergics, sedating antihistamines, tricyclic anti-depressants)
- Change in dose of any psychiatric medications within 4 weeks of screening visit
- Prior use of L-DOPA, any anti-Parkinsonian medication, or prior treatment with anti-amyloid immunotherapy
- Current use of putative mitochondrial enhancers or antioxidants (e.g. carnitine, creatine, Co-Q10, N-acetyl cysteine, pramipexole)
- Initiation of treatment or change in dosing of acetylcholinesterase inhibitors (AChEIs) and memantine within 4 weeks of screening
- Prior use of prescription narcotics 4 weeks before screening
- Female subjects who are pregnant or breastfeeding
- The current use of niacin (or a vitamin supplement with niacin) >200mg within the last two weeks prior to study visit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
McLean Hospital
Belmont, Massachusetts, 02478
Edward de la Cruz, BA, 617-855-2489, edelacruz@mgb.org
Kimaya Reddy, BA, 617-855-3136, kareddy@mclean.harvard.edu
About this study
Official title: Passive Sensor Identification of Digital Biomarkers to Assess Effects of Orally Administered Nicotinamide Riboside on Bioenergetic Metabolism, Oxidative Stress, and Cognition in Mild Cognitive Impairment and Mild Alzheimer's Dementia
This project's main goal is to use state-of-the-art passive sensing techniques to identify digital biomarkers that relate to bioenergetic changes in the brain due to nicotinamide riboside supplementation in those with mild cognitive impairment and mild Alzheimer's dementia.
Read the detailed description
The investigators will conduct a prospective, single-arm, non-interventional study using the Emerald device to monitor the behavior of individuals enrolled in the parent study (ClinicalTrials.gov identifier NCT04430517). Investigators aim to enroll approximately 40 individuals aged 18 -89 (inclusive) with either MCI or mild AD who will have Emerald deployed in their home for up to 12 weeks, spanning the time of approval of parent study screening and formal study enrollment. The Emerald device is a radio-wave sensor that uses signal processing and machine learning algorithms to track the gait, movement, respiration, and sleep of subjects without physical contact or effort by the user, i.e. it neither requires the subject to wear a sensor nor record any data. Emerald works by transmitting low-powered radio signals, 1000x less than Wi-Fi, that reflect off of the subject and return back to the device. If the user moves their arm or leg, or their chest expands and contracts from breathing, that movement changes how the signal reflects off of their body. Emerald records these reflections and processes them using algorithms that convert the radio signals into movement data, breathing rate, sleep stages (Awake, Light, Deep and REM), and key sleep parameters. The device will be deployed in the bedroom of each subject to capture behavior continuously.
- Conditions
- Alzheimer Disease, Dementia Alzheimers, Dementia, Cognitive Impairment, Mild Cognitive Impairment, Neurodegenerative Diseases
- Being tested
- Emerald Device Monitoring
- Keywords
- Passive sensing, Digital phenotyping, Alzheimer's Dementia, Mild Cognitive Impairment, Digital biomarker
- Medical subject headings
- Alzheimer Disease, Dementia, Cognitive Dysfunction, Neurodegenerative Diseases, Neurocognitive Disorders, Cognition Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emerald Device MonitoringDevice
The study participants will have the Emerald device deployed in their home for up to 12 weeks as they participate in the parent study (ClinicalTrials.gov identifier NCT04430517). The device will be deployed in the bedroom of each subject to capture behavior continuously. The Emerald device is a radio-wave sensor that will use signal processing and machine learning algorithms to track the gait, movement, respiration, and sleep of these subjects via low-powered radio signals. Reflections of the radio signals are processed using algorithms to convert them into movement data, sleep stages, and key sleep parameters. These data will supplement bioenergetic, imaging, and biochemical data with digital biomarkers and phenotyping using this device.
| Study group | Role | What they receive |
|---|---|---|
| Parent Study Participants | The single group in this study will consist of individuals enrolled in the parent study (ClinicalTrials.gov identifier NCT04430517). We aim to enroll approximately 40 individuals aged 18 -89 (inclusive) with either MCI or mild AD who will have the Emerald device deployed in their home for up to 12 weeks, spanning the time of approval of parent study screening and formal study enrollment. Receives: Device: Emerald Device Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency
Sleep efficiency will be measured by the Emerald as a ratio of the total sleep time to the time in bed supplemented by tracking participants' wake after sleep onset (WASO), sleep stages (light, deep, REM), sleep latency, and number of awakenings per night.
Measured: Week 0 to week 12 of parent study (ClinicalTrials.gov identifier NCT04430517)
Longitudinal time series of gait speed measurements
Gait speed will be measured by the Emerald device and developed into a longitudinal time series of gait speed (meters per second) throughout the 12-week study.
Measured: Week 0 to week 12 of parent study (ClinicalTrials.gov identifier NCT04430517)
Diurnal rhythm
The diurnal rhythms of study participants will be extracted by using the Emerald device to track patients' spatial location within their living environment and quantifying levels and patterns of motion. This will serve as a marker of psychomotor activity.
Measured: Week 0 to week 12 of parent study (ClinicalTrials.gov identifier NCT04430517)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start31 May 2022
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Ipsit Vihang Vahia, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245903
- Sponsor's protocol ID
- 2021P003275
- Acronym
- Emerald-NRAD
- Status last verified
- Nov 2025
- First submitted
- 21 Dec 2021
- Last updated
- 6 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Sensor Identification of Digital Biomarkers to Assess Effects of Orally Administered Nicotinamide Riboside on Bioenergetic Metabolism, Oxidative Stress, and Cognition in Mild Cognitive Impairment and Mild Alzheimer's Dementia
- ClinicalTrials.gov ID
- NCT05245903
- Acronym / sponsor ID
- Emerald-NRAD / 2021P003275
- Conditions
- Alzheimer Disease, Dementia Alzheimers, Dementia, Cognitive Impairment, Mild Cognitive Impairment, Neurodegenerative Diseases
- Keywords
- Passive sensing, Digital phenotyping, Alzheimer's Dementia, Mild Cognitive Impairment, Digital biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 31 May 2022 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 18 Feb 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.
This project's main goal is to use state-of-the-art passive sensing techniques to identify digital biomarkers that relate to bioenergetic changes in the brain due to nicotinamide riboside supplementation in those with mild cognitive impairment and mild Alzheimer's dementia.
Detailed description
The investigators will conduct a prospective, single-arm, non-interventional study using the Emerald device to monitor the behavior of individuals enrolled in the parent study (ClinicalTrials.gov identifier NCT04430517). Investigators aim to enroll approximately 40 individuals aged 18 -89 (inclusive) with either MCI or mild AD who will have Emerald deployed in their home for up to 12 weeks, spanning the time of approval of parent study screening and formal study enrollment. The Emerald device is a radio-wave sensor that uses signal processing and machine learning algorithms to track the gait, movement, respiration, and sleep of subjects without physical contact or effort by the user, i.e. it neither requires the subject to wear a sensor nor record any data. Emerald works by transmitting low-powered radio signals, 1000x less than Wi-Fi, that reflect off of the subject and return back to the device. If the user moves their arm or leg, or their chest expands and contracts from breathing, that movement changes how the signal reflects off of their body. Emerald records these reflections and processes them using algorithms that convert the radio signals into movement data, breathing rate, sleep stages (Awake, Light, Deep and REM), and key sleep parameters. The device will be deployed in the bedroom of each subject to capture behavior continuously.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parent Study Participants | – | Device: Emerald Device MonitoringThe single group in this study will consist of individuals enrolled in the parent study (ClinicalTrials.gov identifier NCT04430517). We aim to enroll approximately 40 individuals aged 18 -89 (inclusive) with either MCI or mild AD who will have the Emerald device deployed in their home for up to 12 weeks, spanning the time of approval of parent study screening and formal study enrollment. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the existing pool of study subjects for the parent study (MGB IRB protocol #2020P001652, ClinicalTrials.gov identifier NCT04430517). Participation in this supplemental portion of the parent study will be elective for study subjects. Separate informed consent for the installation of the Emerald device will be used, and recruitment for this study will run concurrently with the parent project (IRB protocol #2020P001652, ClinicalTrials.gov identifier NCT04430517). All consented individuals will be targeted for supplemental recruitment for this project.
Key inclusion criteria (9 listed)
- Ability of the participant and/or his/her legally authorized representative to understand the purpose and risks of the study, to provide signed and dated informed consent, and to authorize the use of confidential health information.
- Ability to speak and read fluently in English
- 18-89 years old (inclusive)
- Normal or corrected to normal hearing and vision
- Meet clinical diagnostic criteria for MCI or Mild AD, according to the criteria outlined above
Key exclusion criteria (18 listed)
- Current serious or unstable medical or neurological condition that could affect cognitive functioning, as determined by study clinician
- Clinically unstable mood or anxiety disorder within 6 months prior to screening, as determined by study clinician
- Lifetime history of psychotic disorder (i.e. Schizophrenia, Schizoaffective Disorder), as determined by study clinician
- Diagnosis of a mitochondrial disorder
- Any MRI safety contraindications
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 |
|---|---|---|
| Emerald Device MonitoringThe study participants will have the Emerald device deployed in their home for up to 12 weeks as they participate in the parent study (ClinicalTrials.gov identifier NCT04430517). The device will be deployed in the bedroom of each subject to capture behavior continuously. The Emerald device is a radio-wave sensor that will use signal processing and machine learning algorithms to track the gait, movement, respiration, and sleep of these subjects via low-powered radio signals. Reflections of the radio signals are processed using algorithms to convert them into movement data, sleep stages, and key sleep parameters. These data will supplement bioenergetic, imaging, and biochemical data with digital biomarkers and phenotyping using this device. | Device | Parent Study Participants |
Primary outcome
Sleep efficiency
Time frame: Week 0 to week 12 of parent study (ClinicalTrials.gov identifier NCT04430517)
Sleep efficiency will be measured by the Emerald as a ratio of the total sleep time to the time in bed supplemented by tracking participants' wake after sleep onset (WASO), sleep stages (light, deep, REM), sleep latency, and number of awakenings per night.
Longitudinal time series of gait speed measurements
Time frame: Week 0 to week 12 of parent study (ClinicalTrials.gov identifier NCT04430517)
Gait speed will be measured by the Emerald device and developed into a longitudinal time series of gait speed (meters per second) throughout the 12-week study.
Diurnal rhythm
Time frame: Week 0 to week 12 of parent study (ClinicalTrials.gov identifier NCT04430517)
The diurnal rhythms of study participants will be extracted by using the Emerald device to track patients' spatial location within their living environment and quantifying levels and patterns of motion. This will serve as a marker of psychomotor activity.
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 6 Nov 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Dementia Alzheimers, run by Mclean Hospital at 1 site 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 9 inclusion and 18 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 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Ipsit V Vahia, MD (617-855-2300, ivahia@mclean.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep efficiency (time frame: Week 0 to week 12 of parent study (ClinicalTrials.gov identifier NCT04430517)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.