Study of the Efficacy and Safety of Various Anti-inflammatory Agents in Participants With Mild Cognitive Impairment or Mild Alzheimer's Disease

Summary

The purpose of this platform study was to evaluate the effect of anti-inflammatory agents on cognition in early Alzheimer's disease. Additionally, the safety and tolerability and their effects on central and peripheral inflammation were evaluated. Due to early termination only a single agent could be studied.

Timeline

Start

2021-10-28

Primary completion

2024-03-07

Completion

2024-03-07

Outcome

Missed primary endpoint

Stopped: “Terminated by Sponsor”

registry analysis (superiority test); Canakinumab vs Placebo; p = 0.6386; NCT04795466 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Canakinumab	Monoclonal antibody	300 mg	Subcutaneous

Indications