Passive Sensor Identification of Digital Biomarkers to Assess Effects of Orally Administered 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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 89 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 12 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Investigators aim to enroll approximately 40 individuals aged 18 -89 (inclusive) with either MCI or mild AD who will have Emerald deployed in their home for up to 12 weeks, spanning the time of approval of parent study screening and formal study enrollment."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility 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
Study sites (1)
MA
- McLean Hospital · Belmont, MA 02478Edward de la Cruz, BA · Study contact · 617-855-2489 · edelacruz@mgb.orgKimaya Reddy, BA · Study contact · 617-855-3136 · kareddy@mclean.harvard.eduMore trials in Belmont