Back to search results

Observational Study: Emerald Device Monitoring for Cognitive Impairment

This study is looking at how a device called Emerald can help us understand the effects of nicotinamide riboside in people with mild cognitive impairment (MCI) or mild Alzheimer's dementia. The Emerald device is placed in your bedroom and uses radio waves to quietly track your sleep, movement, and breathing without you needing to wear anything. Researchers want to see if changes in these measurements, called digital biomarkers, are related to how nicotinamide riboside affects the brain. You can join if you are between 18 and 89 years old, speak English, and are already participating in a related study (NCT04430517). The study aims to include about 40 people, but the current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information without giving you a specific treatment. It will include about 40 participants.
What's involved
If you join, the Emerald device will be placed in your bedroom for up to 12 weeks. It will continuously capture your behavior without any effort from you.
Compensation
Not stated in the trial record.
Follow-up
Your sleep efficiency, gait speed, and daily rhythms will be measured from Week 0 to Week 12 of the parent study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05245903

Passive Sensor Identification of Digital Biomarkers to Assess Effects of Orally Administered Nicotinamide Riboside

Recruiting
Not specifiedAges 18–89Observational
Mclean Hospital
~40 participants
Updated 2025-11-06 on ClinicalTrials.gov
What's tested:Emerald Device Monitoring

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sleep efficiency
Measured over Week 0 to week 12 of parent study (ClinicalTrials.gov identifier NCT04430517)
+2 more outcomes measured

Conditions

Alzheimer Disease
Dementia Alzheimers
Dementia
Cognitive Impairment
Mild Cognitive Impairment
Neurodegenerative Diseases
Neurocognitive Disorders
Neurocognitive Dysfunction
Cognitive Dysfunction
Mental Disorder

Explore related trials

Alzheimer's DiseaseMild cognitive disorderAPOE Gene

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Ipsit V Vahia, MD
[email protected]
617-855-2300
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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
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

Exclusion

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
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

What this trial measures

  • Sleep efficiencyWeek 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 measurementsWeek 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 rhythmWeek 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.