The NADage Study: Nicotinamide Riboside Replenishment Therapy Against Functional Decline in Aging
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age75+
SponsorHaukeland University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Nicotinamide Riboside (NR)
Dietary supplementA total of 2000 mg NR is administered daily for 1 year.
Placebo
Other interventionPlacebo tablet identical in taste, shape and appearance to NR tablets.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Placebo groupPlacebo comparator 1 intervention
Group B: NR groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The between-group (NR vs. Placebo) difference in the change in gait speed.
Gait speed is assessed by the 6-minute walk test (6MWT).
Time frame
52 weeksSecondary outcomes
1
Incidence of treatment-emergent adverse events (safety and tolerability).
Monitor the frequency and severity of adverse events (AE).
Time frame
52 weeks2
Change in physical performance assessed by the Short Physical Performance Battery (SPPB).
SPPB is performed as an objective measurements on balance, lower extremity strength, and functional capacity through walking and sit to stand test.
Time frame
52 weeks3
Change in physical performance assessed by hand grip strength.
Grip strength is measured on the dominant hand with a hydraulic hand-held dynamometer.
Time frame
52 weeks4
Change in cognitive function assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) test battery.
The RBANS test battery is composed of tests on immediate memory, visuospatial/constructional abilities, language, attention, and delayed memory. Score range: 40-160. A higher score indicates a better performance.
Time frame
52 weeksOther outcomes
1
Change in daily step count.
Measured in number of steps using Axivity wearable sensors. Counts the total number of steps taken by an individual over a specified period.
Time frame
52 weeks2
Change in overall activity level.
Measured in activity counts using Axivity's accelerometer data. Quantifies the total amount of physical activity based on intensity and duration.
Time frame
52 weeks3
Change in speed of movements.
Measured in per second (m/s) using Axivity's accelerometer and gyroscope data. Calculates the average or peak speed of movements during different activities.
Time frame
52 weeks4
Change in acceleration of movements.
Measured in meters per second squared (m/s2) using Axivity's accelerometer data. Measures the rate of change of speed, indicating how quickly an individual is increasing or decreasing speed during activities. Measured in meters per second squared (m/s\^2) using Axivity's accelerometer data.
Time frame
52 weeksSponsors and contacts
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Source ClinicalTrials.gov