Status:
RECRUITING
Passive Sensor Identification of Digital Biomarkers to Assess Effects of Orally Administered Nicotinamide Riboside
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Alzheimer Disease
Dementia Alzheimers
Eligibility:
All Genders
18-89 years
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 supplementat...
Detailed Description
The investigators will conduct a prospective, single-arm, non-interventional study using the Emerald device to monitor the behavior of individuals enrolled in the parent study (ClinicalTrials.gov iden...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 31 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05245903
Start Date
May 31 2022
End Date
May 31 2026
Last Update
November 6 2025
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478