Actively Recruiting
The NADage Study: Nicotinamide Riboside Replenishment Therapy Against Functional Decline in Aging
Led by Haukeland University Hospital · Updated on 2025-01-20
100
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the potential of nicotinamide riboside (NR) to slow down functional decline in elderly frail adults. This double-blind, randomized, placebo-controlled trial focuses on frailty, a condition associated with aging and linked to decreased levels of nicotinamide adenine dinucleotide (NAD), which plays a role in cell repair and energy production. The study aims to evaluate whether NR, a supplement that may replenish NAD, can improve physical and cognitive functions in this population and assess the safety of daily NR use at 2000 mg. Participants will be randomly assigned to receive either 2000 mg of NR daily or a placebo for 52 weeks. Both treatments are given orally in tablet form twice daily. The study is conducted at a single center and includes 100 individuals identified as frail by the Fried Frailty Phenotype. Researchers will compare changes in gait speed between the two groups, along with other physical and cognitive performance measures. During the year-long study, participants will undergo clinical evaluations including actigraphy to monitor activity, questionnaires, cognitive assessments, and bio sampling with blood, urine, and fecal samples collected. Imaging studies such as magnetic resonance imaging (MRI), 31P-MR-spectrometry to assess brain NAD levels, and FDG-PET scans to evaluate metabolic activity will also be performed. Safety and tolerability will be monitored, and the main measure of success is improvement in gait speed over the 52 weeks.
CONDITIONS
Brief Title
The NADage Study: Nicotinamide Riboside Replenishment Therapy Against Functional Decline in Aging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must understand the study and provide written informed consent
- Male or female aged 75 years or older
- Fried Frailty Phenotype score of 3 or higher
- Montreal Cognitive Assessment (MoCA) adjusted for age, gender, and education with a threshold at the 10th percentile (z-score ≤ -1.28)
You will not qualify if you...
- Unable to provide informed consent
- Does not reside in a facility or institution
- Advanced disability, end-stage disease, severe chronic illness, or life expectancy less than one year
- Unable to complete a 6-minute walk test or has contraindications such as unstable angina or recent myocardial infarction
- Active malignancy diagnosed in the last 2 years (exceptions apply for certain skin and prostate cancers)
- Significant neurological or psychiatric disorders including psychotic disorders, severe mood disorders, multiple sclerosis, uncontrolled seizures, or neurodegenerative disease
- History of cerebrovascular events except for transient ischemic attack more than 3 months prior
- Hospitalization or major surgery within 3 months before baseline
- Significant medication changes less than one month before baseline that interfere with study participation
- Use of NAD precursor supplements within 6 months before baseline
- Elective surgeries planned during the study
- Participation in other clinical trials that could affect frailty measures
- Any medical history that may hinder compliance or increase risk as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive daily doses of either 2000 mg nicotinamide riboside (NR) or placebo for 52 weeks to explore effects on brain and body metabolism, physical and cognitive functions, and safety.
Regular visits for assessments and sample collection during the 52 weeks
Trial Site Locations
Total: 2 locations
1
Haukeland University Hospital
Bergen, Vestland, Norway, 5021
Not Yet Recruiting
2
Haukeland University Hospital
Bergen, Norway, 5021
Actively Recruiting
Research Team
C
Charalampos Tzoulis, PhD
K
Katarina Lundervold, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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