Status:
RECRUITING
The NADage Study: Nicotinamide Riboside Replenishment Therapy Against Functional Decline in Aging
Lead Sponsor:
Haukeland University Hospital
Conditions:
Frailty
Frail Elderly Syndrome
Eligibility:
All Genders
75+ years
Phase:
PHASE2
Brief Summary
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 f...
Detailed Description
This study aims to administer 2000 mg of nicotinamide riboside (NR) daily to explore its effects on brain and body metabolism in an elderly, frail population. The research design is a single-center, d...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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 six months prior to baseline). Specific considerations may apply depending on the type of cancer.
- Significant neurological or psychiatric disorders, including but not limited to psychotic disorders, severe bipolar or unipolar depression, multiple sclerosis, uncontrolled seizure conditions, and neurodegenerative disorder.
- 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.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06208527
Start Date
January 1 2025
End Date
December 1 2030
Last Update
January 20 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Haukeland University Hospital
Bergen, Vestland, Norway, 5021
2
Haukeland University Hospital
Bergen, Norway, 5021