Pharmacokinetic and pharmacodynamic assessment of oral nicotinamide in the NEAT clinical trial for early Alzheimer's disease.

ABSTRACT:

Background

Nicotinamide, a form of B3 vitamin, is an NAD⁺ precursor that reduces pTau₂₃₁ levels via histone deacetylase inhibition in murine models of Alzheimer's disease (AD). A recent phase 2a randomized placebo-controlled trial tested high-dose oral nicotinamide for the treatment of early AD. While nicotinamide demonstrated good safety and tolerability, it did not significantly lower CSF pTau₂₃₁, the primary biomarker endpoint of the study. Characterization of nicotinamide's pharmacokinetics and metabolites in the blood and CSF is needed.

Methods

In these post hoc, blinded analyses of plasma and CSF samples from the completed two-site placebo controlled randomized trial testing of 1500 mg PO BID oral nicotinamide, we used mass spectroscopy

SUBMITTER: Ketron GL 

PROVIDER: S-EPMC11895359 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature