Nicotinamide Riboside therapy to slow aging-related decline in frail elderly

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of nicotinamide riboside (NR) on functional decline in frail elderly individuals. It is designed as a double-blind, randomized, placebo-controlled trial, where participants will receive either 2000 mg of NR daily or a placebo for 52 weeks. The primary focus is to evaluate changes in gait speed, while secondary outcomes will assess safety, tolerability, and cognitive and physical functions through various standardized tests and assessments. The study aims to gather biological samples and utilize advanced imaging techniques to analyze the impact of NR on metabolism and brain health.

Why it matters

Who can join: the full rules

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.

Where it's running

• Haukeland University Hospital
  Bergen, Norway Recruiting
• Haukeland University Hospital
  Bergen, Vestland, Norway Not yet recruiting

Study contacts

• Study coordinator: Charalampos Tzoulis, PhD
• Email: charalampos.tzoulis@helse-bergen.no
• Phone: 55975061

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.