Recruiting

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

Sponsor:

Mclean Hospital

Code:

NCT05245903

Conditions

Alzheimer Disease

Dementia Alzheimers

Dementia

Cognitive Impairment

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Emerald Device Monitoring

Study Details

Brief 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.

Conditions

Alzheimer Disease

Dementia Alzheimers

Dementia

Cognitive Impairment

Mild Cognitive Impairment

Study ID

NCT05245903

Start date

May 31, 2022

Status verified date

Nov, 2025

Completion date

May 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Emerald 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.

Primary outcome measure

Sleep efficiency [ Time Frame: Week 0 to week 12 of parent study (ClinicalTrials.gov identifier NCT04430517) ]
Longitudinal time series of gait speed measurements [ Time Frame: Week 0 to week 12 of parent study (ClinicalTrials.gov identifier NCT04430517) ]
Diurnal rhythm [ Time Frame: Week 0 to week 12 of parent study (ClinicalTrials.gov identifier NCT04430517) ]

Central Contacts and Locations

Central contacts

Ipsit V Vahia, MD

617-855-2300 ivahia@mclean.harvard.edu

Brent P Forester, MD, MSc

617-855-3622 bforester@mclean.harvard.edu

Locations

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

Contacts

Edward de la Cruz, BA

617-855-2489 edelacruz@mgb.org

Kimaya Reddy, BA

617-855-3136 kareddy@mclean.harvard.edu

More Information

Sponsor

Mclean Hospital

Last update posted

Nov 6, 2025

Last verified

Nov, 2025

Keywords

Passive sensing
Digital phenotyping
Alzheimer's Dementia
Mild Cognitive Impairment
Digital biomarker

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mclean Hospital on 2025-11-06.