Actively Recruiting
Passive Sensor Identification of Digital Biomarkers to Assess Effects of Orally Administered Nicotinamide Riboside
Led by Mclean Hospital · Updated on 2025-11-06
40
Participants Needed
1
Research Sites
208 weeks
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
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
Official 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 signed informed consent, and authorize use of health information
- Ability to speak and read fluently in English
- Age between 18 and 89 years inclusive
- Normal or corrected hearing and vision
- Meet clinical criteria for mild cognitive impairment or mild Alzheimer's dementia
- Have a study partner available during the trial
- Have at least one copy of the APOE 4 allele
- Have an aggregate risk score greater than 4 per Sabbagh et al. (2017)
- Complete a two-week wash-out if taking niacin or vitamin supplements with niacin above 200mg
You will not qualify if you...
- Serious or unstable medical or neurological conditions affecting cognition
- Unstable mood or anxiety disorder within 6 months before screening
- Lifetime history of psychotic disorders such as schizophrenia or schizoaffective disorder
- Diagnosis of a mitochondrial disorder
- Any contraindications for MRI
- History of drug hypersensitivity or intolerance to nicotinamide riboside
- Transient ischemic attack or stroke within 1 year before screening
- Alcohol or substance abuse within the prior year
- Moderate or worse head injury per DSM-5 criteria
- Seizure history within the past 10 years
- Current use of medications known to impair cognition like benzodiazepines or anticholinergics
- Changes in psychiatric medication doses within 4 weeks before screening
- Prior use of L-DOPA, anti-Parkinsonian drugs, or anti-amyloid immunotherapy
- Current use of mitochondrial enhancers or antioxidants such as carnitine or Co-Q10
- Recent changes in acetylcholinesterase inhibitors or memantine within 4 weeks before screening
- Use of prescription narcotics within 4 weeks before screening
- Pregnant or breastfeeding females
- Use of niacin supplements over 200mg within 2 weeks before study visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
McLean Hospital
Belmont, Massachusetts, United States, 02478
Actively Recruiting
Research Team
I
Ipsit V Vahia, MD
CONTACT
B
Brent P Forester, MD, MSc
CONTACT
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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