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

Plain-language guide to NCT06208527: phase 2 randomized trial of NAD+, 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06208527
Phase
phase 2
Status
recruiting participants
Start
2025-01
Completion (planned or actual)
2027-12
Participants
100 (estimated)
Design
randomized, triple-blind, treatment
Conditions studied
Frailty; Frail Elderly Syndrome; Frailty Syndrome; Aging
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around NAD+.

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.

It had two arms (groups): Placebo group (placebo comparator) and NR group (experimental).

Placebo, no active ingredients. Administered in tablet form twice daily for the duration of the trial (1 year).

The registry classes the interventions as dietary supplement and other.

More on the Plan

The research design is a single-center, double-blind, randomized, placebo-controlled approach.

The intervention will last for 52 weeks, during which primary and secondary outcomes will be assessed across and within both groups.

The primary objective is to evaluate the impact of NR on gait speed by comparing the treatment group with the placebo group.

Secondary objectives include assessing the safety and tolerability of NR, as well as its clinical effects on physical and cognitive functions, using standardized tests.

Who Took Part

Enrollment: 100 planned participants were the target.

It was open to people of any sex aged from 75 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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).

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got NAD+ and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on NAD+, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2025-01 with completion listed for 2027-12.

It ran at 2 sites in Norway (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The between-group (NR vs. Placebo) difference in the change in gait speed (time frame: 52 weeks).

It also tracked 4 secondary outcomes, for example Incidence of treatment-emergent adverse events (safety and tolerability), Change in physical performance assessed by the Short Physical Performance Battery (SPPB), Change in physical performance assessed by hand grip strength and Change in cognitive function assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) test battery.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of NAD+ in 100 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, all human trials.

Our Notes on the Compound

NAD+: The coenzyme that accepts electrons at complex I.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.