Disease: Age-related frailty and associated cognitive dysfunction
Type of study: Interventional trial
Coordinating investigator: Katarina Lundervold
Study director: Charalampos Tzoulis
Background: Frailty is a major source of morbidity and disability, as well as a prodromal state for cognitive impairment and dementia. Thus, frailty allows us to intervene in pre-dementia states before neurodegeneration has reached a point of no return. Preclinical and clinical evidence supports that NAD-replenishment therapy with NR targets molecular processes that play key role in frailty and neurodegeneration (i.e., mitochondrial function, proteostasis, and neuroinflammation). We will, therefore, test whether NR treatment can ameliorate frailty and associated cognitive, motor, and other forms of dysfunction.
In the NADage trial, 100 trial participants will be recruited and randomly assigned (1:1) to either NR 2,000 mg (1,000 mg x 2) daily (n=50), or placebo (n=50) for a 52-week period. During the study period, participants will be assessed at five in-clinic visits (week 0, 12, 26, 40, 52) with clinical, neuroimaging, and laboratory measures, in addition to long-term monitoring using wearables.
Primary objective is to assess the efficacy of NR in improving motor function in elderly, community-dwelling, frail individuals.
Status: Funding is secured, and screening started in Q4 2024 and will initiate recruitment in Q1 2025.
Participating centre
- Haukeland University Hospital, Bergen
Funding
- Horizon – ERA4HEALTH
- The Research Council of Norway, Neuro-SysMed
- Haukeland University Hospital
- The University of Bergen
- The DAM Foundation
- The GC Rieber Foundation