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.
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
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
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.
Case-only
Cross-sectional
Emerald Device Monitoring
DeviceThe 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.
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.
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.
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.
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Mclean Hospital
Lead sponsor
National Institute on Aging (NIA)
Collaborator
