Investigating Nicotinamide Riboside for Mild Cognitive Impairment and Alzheimer's
Effects of Orally Administered Nicotinamide Riboside on Bioenergetic Metabolism, Oxidative Stress and Cognition in Mild Cognitive Impairment and Mild Alzheimer's Dementia
This study is testing if a supplement called nicotinamide riboside can help people with mild cognitive impairment and mild Alzheimer's improve their brain function and slow down memory loss.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 55 Years to 89 Years |
| Sex | All |
| Sponsor | Mclean Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Belmont, Massachusetts) |
| Trial ID | NCT04430517 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the effects of nicotinamide riboside (NR) on brain energy metabolism, oxidative stress, and cognitive function in individuals diagnosed with mild cognitive impairment (MCI) and mild Alzheimer's dementia (AD). By utilizing novel neuroimaging techniques, the research will assess how NR supplementation may enhance mitochondrial function and potentially slow or reverse cognitive decline associated with these conditions. Participants will undergo evaluations to confirm their eligibility based on specific clinical criteria and biomarker assessments.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55-89 with a diagnosis of mild cognitive impairment or mild Alzheimer's dementia who carry specific genetic markers or biomarkers indicative of Alzheimer's pathology.
Not a fit: Patients without the APOE ε4 allele or those who do not meet the clinical diagnostic criteria for MCI or mild AD may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic approach to improve cognitive function and quality of life for patients with mild cognitive impairment and Alzheimer's disease.
How similar studies have performed: While numerous studies have explored the effects of nicotinamide riboside in various contexts, this specific investigation into its effects on cognitive function in MCI and mild AD is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion 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 * 55-89 years old (inclusive) * Normal or corrected to normal hearing and vision * Meet clinical diagnostic criteria for MCI or Mild AD, according to the following criteria: 1. CDR Global Score of 0.5 (MCI) or 1.0 (mild AD) 2. 2018 NIA-AA guidelines for MCI/mild AD * Study partner available for the duration of trial participation * At least one copy of the APOE ε4 allele or AD+ including Amyloid positive PET scan, Tau positive PET Scan (MK6240 et al.), or CSF AD biomarkers \[i.e., amyloid-beta beta (Aβ42) total (T)-tau, and phosphorylated (P)-tau\] * 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, centrally acting 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 and antioxidants (e.g carnitine, creatine Co-Q10, N-acetyl cysteine \[NAC\], pramipexole) * Initiation of treatment or change in dosing of acetylcholinesterase inhibitors (AChEIs) and memantine within 4 weeks of baseline visit * Prior use of prescription narcotics 4 weeks before baseline visit * Female subjects who are pregnant or breastfeeding * The use of current use of niacin (or a vitamin supplement with niacin) \>200mg within the last two weeks prior to study visit. * Current or lifetime history of cancer.
Where this trial is running
Belmont, Massachusetts
- McLean Hospital — Belmont, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Fei Du, PhD — Mclean Hospital
- Study coordinator: Fei Du, PhD
- Email: fdu@mclean.harvard.edu
- Phone: 6178552710
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.