Alzheimer Disease Clinical Trial
— Emerald-NRADOfficial title:
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'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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | April 30, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | 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 e4 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Mclean Hospital | National Institute on Aging (NIA) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sleep efficiency | Sleep efficiency will be measured by the Emerald as a ratio of the total sleep time to the time in bed supplemented by tracking participants' wake after sleep onset (WASO), sleep stages (light, deep, REM), sleep latency, and number of awakenings per night. | Week 0 to week 12 of parent study (ClinicalTrials.gov identifier NCT04430517) | |
Primary | Longitudinal time series of gait speed measurements | Gait speed will be measured by the Emerald device and developed into a longitudinal time series of gait speed (meters per second) throughout the 12-week study. | Week 0 to week 12 of parent study (ClinicalTrials.gov identifier NCT04430517) | |
Primary | Diurnal rhythm | The diurnal rhythms of study participants will be extracted by using the Emerald device to track patients' spatial location within their living environment and quantifying levels and patterns of motion. This will serve as a marker of psychomotor activity. | Week 0 to week 12 of parent study (ClinicalTrials.gov identifier NCT04430517) |
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