Actively Recruiting
The NADage Study: Nicotinamide Riboside Therapy to Slow Functional Decline in Aging A Randomized, Double-Blind, Placebo-Controlled Trial in Frail Elderly Adults
Led by Haukeland University Hospital · Updated on 2025-01-20
100
Participants Needed
2
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of nicotinamide riboside (NR) on slowing down functional decline in elderly frail individuals. This phase 2, double-blind, randomized, placebo-controlled trial focuses on frailty and aging, studying whether NR, which increases nicotinamide adenine dinucleotide (NAD) levels, can improve physical and cognitive symptoms in this population. Previous studies in animals and patients with Parkinson's disease showed promising neuroprotective effects of NR, and this trial aims to explore its potential benefits further for frailty without neurodegenerative disorders. Participants will be randomly assigned to receive either 2000 mg of NR daily or a matching placebo for 52 weeks. The trial is conducted at a single center and includes equal allocation to both groups. During the study, researchers will assess changes in gait speed as the primary outcome. Secondary outcomes will evaluate safety, tolerability, and clinical effects on physical and cognitive functions. Exploratory assessments include questionnaires, biosampling of blood, urine, feces, actigraphy to monitor activity, and brain imaging such as MRI, FDG-PET, and 31P-MR spectroscopy to analyze NAD metabolism. Participants will undergo clinical evaluations, cognitive testing, and various biological sample collections throughout the year-long study. Safety and effectiveness will be monitored continuously, with data collected on physical performance and brain metabolism. The trial includes 100 frail elderly individuals aged 75 or older, with detailed follow-up involving standardized tests and advanced imaging. The goal is to determine whether NR can reduce frailty symptoms, offering potential benefits to affected individuals and society.
CONDITIONS
Official Title
The NADage Study: Nicotinamide Riboside Replenishment Therapy Against Functional Decline in Aging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understands the study and can provide written informed consent
- Male or female aged 75 years or older at baseline
- Frailty defined by Fried Frailty Phenotype score of 3 or higher
- Montreal Cognitive Assessment (MoCA) score at screening adjusted to age, gender, and education at or below the 10th percentile (z-score ≤ -1.28)
You will not qualify if you...
- Unable to provide informed consent
- Not residing 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 contraindications to it (e.g., recent unstable angina or myocardial infarction within 30 days)
- Active malignancy diagnosed within 2 years prior to baseline (except certain non-metastatic skin or stable prostate cancers)
- Significant neurological or psychiatric disorders including psychotic disorders, severe bipolar or unipolar depression, multiple sclerosis, uncontrolled seizures, or neurodegenerative disorders
- History of cerebrovascular events except transient ischemic attack more than 3 months before baseline
- Hospitalization or major surgery within 3 months before baseline
- Significant medication or treatment changes within 1 month before baseline that interfere with study participation
- Use of NAD precursor supplements (e.g., nicotinamide riboside, nicotinamide mononucleotide, or Vitamin B3) within 6 months before baseline
- Elective surgeries planned during the study period
- Participation in other clinical trials with interventions affecting frailty measures
- Any medical condition judged by the investigator to hinder study compliance or increase participant risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here