RecruitingNCT05245903

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

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

Sponsor

Mclean Hospital

Enrollment

40 participants

Start Date

May 31, 2022

Study Type

OBSERVATIONAL

Conditions

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

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.

Eligibility

Min Age: 18 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a supplement called nicotinamide riboside (a form of vitamin B3) can help people with mild memory or thinking problems. Researchers will also use smartphone-based sensors and digital tools to track how thinking ability changes over time. The goal is to see if this supplement slows early cognitive decline. **You may be eligible if...** - You are between 18 and 89 years old - You have been diagnosed with mild cognitive impairment (MCI) or early Alzheimer's disease - You carry at least one copy of the APOE ε4 gene (a genetic risk factor for Alzheimer's) - You have a study partner (like a family member) available for the duration of the trial - You can read and speak fluent English - Your hearing and vision are normal or corrected to normal **You may NOT be eligible if...** - You have an unstable medical or neurological condition affecting thinking - You have had an unstable mood or anxiety disorder in the last 6 months - You have a history of a psychotic disorder (e.g., schizophrenia) - You are taking high-dose niacin (>200mg) without completing a 2-week washout period first Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEmerald Device Monitoring

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.