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Effects of Nicotinamide Riboside on Bioenergetics and Oxidative Stress in Mild Cognitive Impairment/Alzheimer's Dementia

Plain-language guide to NCT04430517: early phase 1 interventional trial of NAD+, dementia, alzheimer's & cognitive decline, 21 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04430517
Phase
early phase 1
Status
completed
Start
2022-03-02
Completion (planned or actual)
2026-04-29
Participants
21 (actual)
Design
na, open label (everyone knows who gets what), basic_science
Conditions studied
Mild Cognitive Impairment; Mild Alzheimer Disease
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this early phase 1 trial, researchers set out to test NAD+ for dementia, alzheimer's & cognitive decline.

The primary aim of this study is to investigate the effects of exogenously administered nicotinamide riboside (NR) on brain energy metabolism, oxidative stress, and cognitive function in individuals with mild cognitive impairment (MCI) and mild Alzheimer's dementia (AD).

It had 1 arm (groups): Mild Cognitive Impairment and Alzheimer's Dementia (experimental).

The registry classes the interventions as drug.

More on the Plan

Mitochondrial function is mediated, in part, by nicotinamide adenine dinucleotide (NAD).

Numerous preclinical and clinical studies have been performed using NR and related compounds to boost NAD+ level in human subjects with various diseases or animal models.

Who Took Part

21 actual participants took part.

It was open to people of any sex aged from 55 years up to 89 years.

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

Examples of who could join: Ability to speak and read fluently in English. 55-89 years old (inclusive). Normal or corrected to normal hearing and vision. Meet clinical diagnostic criteria for MCI or Mild AD, according to the following criteria:. CDR Global Score of 0.5 (MCI) or 1.0 (mild AD).

The full record lists 11 inclusion and 19 exclusion criteria; among the exclusions: current serious or unstable medical or neurological condition that could affect cognitive functioning, as determined by study clinician; clinically unstable mood or anxiety disorder within 6 months prior to screening, as determined by study clinician; lifetime history of psychotic disorder (i.e. schizophrenia, schizoaffective disorder), as determined by study clinician.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when NAD+ was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2022-03-02 with completion listed for 2026-04-29.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Changes in brain NAD+. Changes in brain redox state.

It also tracked 2 secondary outcomes, for example Changes in mitochondrial function and Changes in antioxidant glutathione (GSH) levels.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of NAD+ in 21 people with dementia, alzheimer's & cognitive decline.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, Dementia, Alzheimer's & cognitive decline research.

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.