NCT05245903 · RECRUITING
Passive Sensor Identification of Digital Biomarkers to Assess Effects of Orally Administered Nicotinamide Riboside
This trial is testing whether a supplement called nicotinamide riboside (a form of vitamin B3) produces measurable changes in brain energy metabolism in people with mild cognitive impairment or mild Alzheimer's dementia. Researchers are using a passive home sensor device to track digital biomarkers — things like sleep, movement, and breathing patterns — rather than clinic visits alone. The phase is unspecified, so the scale and stage of testing are unclear from the available information.
You may qualify if
- 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
You're excluded if
- 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-11-06