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
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical study, designed as a double-blind, randomized, placebo-controlled trial, aims to investigate the potential of nicotinamide riboside (NR) to decelerate functional decline in the elderly frail population. In animal studies, NR, which is converted to nicotinamide adenine dinucleotide (NAD), has shown potential as a neuroprotective agent, with indications of protection against amyotrophic lateral sclerosis (ALS), Alzheimer's dementia, and Parkinson's disease. Furthermore, aging is commonly associated with decreased tissue NAD levels, a phenomenon linked to premature aging and a spectrum of age-related disorders, including cardiovascular diseases and cancers. Existing preclinical and clinical research highlights the promise of NAD replenishment through enhanced DNA repair, sirtuin activity, and improved mitochondrial function. The research center has conducted two phase II clinical trials on NR for Parkinson's disease (NAD-PARK and NR-SAFE), administering up to 3000 mg of NR daily. These trials have shown promising results, indicating NR's potential as a treatment that may alter the course of the disease and possibly as neuroprotective treatment in Parkinson's disease. The NAD age trial primarily aims to determine: * The efficacy of NAD therapy in improving clinical symptoms of frailty, evaluated through standardized physical and cognitive function tests. * The safety of administering 2000 mg NR daily in an elderly frail population. The study will include 100 individuals, classified as frail based on the Fried Frailty Phenotype. Participants will be randomly assigned to receive either 2000 mg of NR daily or a placebo. Over a 52-week period, participants will undergo: * Clinical evaluations, including actigraphy and questionnaires. * Cognitive assessments. * Bio sampling. * Magnetic resonance imaging (MRI). * Positron emission tomography (FDG-PET) scanning. The outcomes of this study could potentially demonstrate that NR effectively reduces signs of frailty, offering considerable advantages to the individuals affected, their families, and society as a whole.
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
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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
CONTACT
K
Katarina Lundervold, MD
CONTACT
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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