Using a passive home sensor to find digital signs of brain energy changes from 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
This project will try a contact-free home sensor to see if it can detect activity, sleep, and breathing changes related to nicotinamide riboside in people with mild cognitive impairment or mild Alzheimer's.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Mclean Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Belmont, Massachusetts) |
| Trial ID | NCT05245903 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm observational study deploying the Emerald radio-wave sensor in the bedrooms of about 40 participants enrolled in a parent nicotinamide riboside study (NCT04430517). The Emerald device continuously records reflected low-power radio signals and uses signal processing and machine learning to derive movement, gait, respiration rate, sleep stages, and other digital features without requiring wearable devices. Data collection will span up to 12 weeks around the parent study screening and enrollment period to capture behavioral and sleep patterns while participants take nicotinamide riboside. Investigators will analyze the derived digital biomarkers to identify patterns that relate to bioenergetic changes in the brain associated with supplementation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–89 with a clinical diagnosis of mild cognitive impairment or mild Alzheimer's dementia, at least one APOE ε4 allele, an available study partner, English fluency, and a bedroom suitable for device placement.
Not a fit: People without MCI or mild AD, those who do not carry an APOE ε4 allele, those with unstable medical or neurological conditions, lacking a study partner, or who cannot have the device installed in their bedroom are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could provide an unobtrusive way to monitor treatment-related changes in activity, sleep, and breathing that might serve as objective digital biomarkers for people with early cognitive impairment.
How similar studies have performed: Passive sensing and digital phenotyping studies have shown promising correlations between sleep/activity measures and cognitive status, but applying passive radio-wave sensors to detect bioenergetic effects of nicotinamide riboside is a novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Belmont, Massachusetts
- McLean Hospital — Belmont, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Ipsit V Vahia, MD
- Email: ivahia@mclean.harvard.edu
- Phone: 617-855-2300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.