{"type":"trials","record":{"id":21632,"source_id":"clinicaltrials-gov","external_id":"NCT06208527","title":"The NADage Study: Nicotinamide Riboside Replenishment Therapy Against Functional Decline in Aging","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 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. Furthermore, aging is commonly associated with decreased tissue NAD levels, a phenomenon linked to premature aging and a spectrum of age-related disorders, including cardiovascular diseases and cancers. Existing preclinical and clinical research highlights the promise of NAD replenishment through enhanced DNA repair, sirtuin activity, and improved mitochondrial function. The research center has conducted two phase II clinical trials on NR for Parkinson's disease (NAD-PARK and NR-SAFE), administering up to 3000 mg of NR daily. These trials have shown promising results, indicating NR's potential as a treatment that may alter the course of the disease and possibly as neuroprotective treatment in Parkinson's disease. The NAD age trial primarily aims to determine: * The efficacy of NAD therapy in improving clinical symptoms of frailty, evaluated through standardized physical and cognitive function tests. * The safety of administering 2000 mg NR daily in an elderly frail population. The study will include 100 individuals, classified as frail based on the Fried Frailty Phenotype. Participants will be randomly assigned to receive either 2000 mg of NR daily or a placebo. Over a 52-week period, participants will undergo: * Clinical evaluations, including actigraphy and questionnaires. * Cognitive assessments. * Bio sampling. * Magnetic resonance imaging (MRI). * Positron emission tomography (FDG-PET) scanning. The outcomes of this study could potentially demonstrate that NR effectively reduces signs of frailty, offering considerable advantages to the individuals affected, their families, and society as a whole.","overall_status":"Recruiting","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Haukeland University Hospital","enrollment":100,"countries":["Norway"],"start_date":"2025-01-01","completion_date":"2030-12-01","last_update_date":"2025-01-20","source_url":"https://clinicaltrials.gov/study/NCT06208527","editorial_summary":"A registered PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-24T01:17:08.26846+00:00","last_seen_at":"2026-09-25T06:10:25.747+00:00","metadata":{"sex":"ALL","acronym":"NADage","age_range":"75 Years","comparator":"Placebo group","organization":"Haukeland University Hospital","interventions":["Nicotinamide Riboside (NR)","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["The between-group (NR vs. Placebo) difference in the change in gait speed. — 52 weeks","Incidence of treatment-emergent adverse events (safety and tolerability). — 52 weeks","Change in physical performance assessed by the Short Physical Performance Battery (SPPB). — 52 weeks","Change in physical performance assessed by hand grip strength. — 52 weeks","Change in cognitive function assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBA…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","source_has_results":false},"controlled_terms":["Frailty","Frail Elderly Syndrome","Frailty Syndrome","Aging","Nicotinamide Riboside (NR)","Placebo"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: nicotinamide riboside.","quality_checked_at":"2026-09-25T06:10:37.875473+00:00","duplicate_cluster_key":"id:nct06208527","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-01-01 to 2030-12-01","comparator":"Placebo group","confidence":"structured-source","population":"ALL · 75 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:25.835Z","intervention":["Nicotinamide Riboside (NR)","Placebo"],"participants":100,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE2","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["The between-group (NR vs. Placebo) difference in the change in gait speed. — 52 weeks","Incidence of treatment-emergent adverse events (safety and tolerability). — 52 weeks","Change in physical performance assessed by the Short Physical Performance Battery (SPPB). — 52 weeks","Change in physical performance assessed by hand grip strength. — 52 weeks","Change in cognitive function assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBA…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"nad-metabolism","is_published":true,"match_reasons":["Title contains controlled term: nicotinamide riboside.","Abstract contains controlled term: nicotinamide riboside.","Source terminology contains: nicotinamide riboside.","Title supplies longevity context: aging.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"NAD metabolism","slug":"nad-metabolism"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/21632","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}