Nicotinamide Riboside therapy to slow aging-related decline in frail elderly
The NADage Study: a Randomized Double-blind Trial of NAD Replenishment Therapy on Aging
This study is testing if taking nicotinamide riboside can help frail older adults maintain their walking speed and overall health over a year.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Haukeland University Hospital Academic / other |
| Locations | 2 sites (Bergen, Vestland and 1 other locations) |
| Trial ID | NCT06208527 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of nicotinamide riboside (NR) on functional decline in frail elderly individuals. It is designed as a double-blind, randomized, placebo-controlled trial, where participants will receive either 2000 mg of NR daily or a placebo for 52 weeks. The primary focus is to evaluate changes in gait speed, while secondary outcomes will assess safety, tolerability, and cognitive and physical functions through various standardized tests and assessments. The study aims to gather biological samples and utilize advanced imaging techniques to analyze the impact of NR on metabolism and brain health.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 75 years and older who meet the Fried Frailty Phenotype criteria and have a low score on the Montreal Cognitive Assessment.
Not a fit: Patients with advanced disabilities, severe chronic illnesses, or those who cannot provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve physical and cognitive functions in frail elderly patients, potentially enhancing their quality of life.
How similar studies have performed: Previous studies have shown promise in using nicotinamide riboside for neurodegenerative conditions, suggesting potential for success in this novel application for frailty.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant must understand the nature of the study and be able to provide written, informed consent. * Male or female aged ≥ 75 years at baseline. * Fried Frailty Phenotype score ≥ 3 to identify frail individuals. * Montreal Cognitive Assessment (MoCA) at screening adjusted to age, gender, and educational level, with a threshold set at the 10th percentile (z-score ≤ -1.28). Exclusion Criteria: * Inability to provide informed consent. * Does not reside in a facility or institution. * Advanced disability, end-stage disease, presence of severe chronic illness and/or life expectancy of less than a year. * Inability to complete a 6-minute walk test (6MWT) and/or contraindications to the procedure (history of unstable angina or myocardial infarction within 30 days prior to the test). * Diagnosis of active malignancy in the last 2 years at baseline (exceptions include non-metastatic skin conditions and non-metastatic and/or treated prostate cancer with stable prostate-specific antigen (PSA) levels in six months prior to baseline). Specific considerations may apply depending on the type of cancer. * Significant neurological or psychiatric disorders, including but not limited to psychotic disorders, severe bipolar or unipolar depression, multiple sclerosis, uncontrolled seizure conditions, and neurodegenerative disorder. * A history of cerebrovascular events, excluding transient ischemic attack (TIA) that occurs more than 3 months prior to baseline. * Hospitalization or major surgery within 3 months prior to baseline. * Significant changes in medications or treatment plans made less than one month prior to baseline, judged by the site investigator to interfere with the subject's participation in the study. * Consumption of NAD precursor supplements (e.g., Nicotinamide riboside, nicotinamide mononucleotide or Vitamin B3), or related supplements within 6 months prior to baseline. * Elective surgeries scheduled during the study duration. * Concurrent participation in other clinical trials with interventions that could affect frailty measures. * Any medical history, at the discretion of the investigator, might hinder compliance with study procedures or increase risk to the participant.
Where this trial is running
Bergen, Vestland and 1 other locations
- Haukeland University Hospital — Bergen, Vestland, Norway (Not_yet_recruiting)
- Haukeland University Hospital — Bergen, Norway (Recruiting)
Study contacts
- Study coordinator: Charalampos Tzoulis, PhD
- Email: charalampos.tzoulis@helse-bergen.no
- Phone: 55975061
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.