Actively Recruiting
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
Led by Mclean Hospital · Updated on 2025-11-06
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mclean Hospital
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the use of passive sensing technology to identify digital markers related to brain energy changes from nicotinamide riboside supplementation in people with mild cognitive impairment or mild Alzheimer's dementia. This observational study focuses on adults aged 18 to 89 who have either mild cognitive impairment or mild Alzheimer's disease. The goal is to better understand bioenergetic metabolism, oxidative stress, and cognition through these digital markers. Participants will have the Emerald device, a radio-wave sensor, placed in their bedroom for up to 12 weeks. This device continuously monitors movement, breathing, gait, and sleep stages like Awake, Light, Deep, and REM without any physical contact or effort from the participant. The device uses low-powered radio signals and machine learning to convert reflections into detailed activity and sleep data, supplementing other biological and imaging information collected in the parent study. During the study, the Emerald device will collect continuous behavioral data while participants are also involved in the parent clinical trial. Researchers will assess outcomes such as sleep efficiency, gait speed over time, and daily activity rhythms across the 12-week period. This monitoring aims to provide digital biomarkers that relate to changes in brain bioenergetics and cognitive function. Participants' usual care continues alongside this monitoring, and the study runs until May 2026.
CONDITIONS
Brief Title
Passive Sensor Identification of Digital Biomarkers to Assess Effects of Orally Administered Nicotinamide Riboside
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability of the participant and/or legally authorized representative to understand the study purpose and risks, provide informed consent, and authorize use of health information
- Ability to speak and read English fluently
- Age between 18 and 89 years inclusive
- Normal or corrected to normal hearing and vision
- Meet clinical criteria for mild cognitive impairment or mild Alzheimer's dementia
- Have a study partner available for the trial duration
- Have at least one copy of the APOE b54 allele
- Have an aggregate risk score greater than 4 as per the specified method
- Completion of a two-week wash-out if currently taking niacin or supplements with niacin over 200mg
You will not qualify if you...
- Current serious or unstable medical or neurological conditions affecting cognition
- Clinically unstable mood or anxiety disorder within 6 months before screening
- Lifetime history of psychotic disorders such as schizophrenia
- Diagnosis of mitochondrial disorders
- Contraindications for MRI
- History of drug hypersensitivity or intolerance to nicotinamide riboside
- Transient ischemic attack or stroke within 1 year prior to screening
- History of alcohol or substance abuse within the prior year
- Moderate or worse head injury per DSM-5 criteria
- History of seizure within the past 10 years
- Current use of medications known to adversely affect cognition
- Recent changes in psychiatric medications within 4 weeks
- Prior use of L-DOPA or anti-Parkinsonian medications or anti-amyloid immunotherapy
- Current use of mitochondrial enhancers or antioxidants
- Recent changes in acetylcholinesterase inhibitors or memantine within 4 weeks
- Recent use of prescription narcotics within 4 weeks
- Pregnant or breastfeeding females
- Use of niacin or supplements over 200mg within 2 weeks prior to study visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants will have the Emerald device deployed in their home bedroom to continuously monitor their gait, movement, respiration, and sleep behavior without any physical contact or effort.
Continuous remote monitoring with the device deployed in the home
Trial Site Locations
Total: 1 location
1
McLean Hospital
Belmont, Massachusetts, United States, 02478
Actively Recruiting
Research Team
I
Ipsit V Vahia, MD
B
Brent P Forester, MD, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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