The NADage Study: Nicotinamide Riboside Replenishment Therapy Against Functional Decline in Aging

Launched by HAUKELAND UNIVERSITY HOSPITAL · Jan 4, 2024

Keywords

ClinConnect Summary

The NADage Study is a clinical trial investigating whether a supplement called nicotinamide riboside (NR) can help older adults who are frail maintain their physical and mental abilities. As people age, they often experience a decline in these functions, which can lead to increased frailty and related health issues. This study aims to find out if taking 2000 mg of NR daily for a year can improve symptoms of frailty and if it is safe for older adults. Researchers will evaluate the participants' progress through various tests, including physical activity tracking, cognitive assessments, and brain imaging.

To be eligible for the study, participants need to be 75 years or older and meet specific criteria indicating they are frail. They must also be able to provide informed consent and complete simple physical tests. The trial will include 100 individuals, who will either receive the NR supplement or a placebo (a non-active treatment) without knowing which one they are taking. This study is important because it could lead to new ways to help frail elderly individuals improve their quality of life and manage age-related health challenges.

Gender

ALL

Eligibility criteria

• Inclusion 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).
• Exclusion Criteria:
• • 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.