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

Part of paid clinical trials in Belmont, Massachusetts.

Sponsor
Mclean Hospital
Study ID
NCT05245903
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Emerald Device Monitoring — DEVICE
    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 Details

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.

Key Dates

Start date
May 31, 2022
Status verified
Nov 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Sleep efficiency [ Time Frame: Week 0 to week 12 of parent study (ClinicalTrials.gov identifier NCT04430517) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
McLean HospitalBelmontMassachusetts02478
Edward de la Cruz, BA
[email protected]
617-855-2489
Kimaya Reddy, BA
[email protected]
617-855-3136

Find similar trials in Belmont, MA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
McLean Hospital· Belmont, MA

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