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New treatment option for Frailty
Official title The NADage Study: Nicotinamide Riboside Replenishment Therapy Against Functional Decline in Aging
ClinicalTrials.gov ID: NCT06208527
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 52 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 75 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Diagnosis of active malignancy in the last 2 years at baseline (exceptions include non-metastatic skin conditions and non-metastatic and/or treated...
- Significant neurological or psychiatric disorders, including but not limited to psychotic disorders, severe bipolar or unipolar depression, multiple...
See the full eligibility 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).
- 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...
- Significant neurological or psychiatric disorders, including but not limited to psychotic disorders, severe bipolar or unipolar depression, multiple sclerosis, uncontrolled seizure conditions, and neurodegenerative...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bergen, Vestland, Norway
- Bergen, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 75 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bergen, Vestland, Norway; Bergen, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.