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

Alzheimer Disease Clinical Trial

Official title: Exploratory PLatform Trial on Anti-Inflammatory Agents in Alzheimer's Disease (EXPLAIN-AD): A Randomized, Placebo-controlled, Multicenter Platform Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Various Anti-inflammatory Agents in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease

Status Terminated

Clinical Trial Summary

The purpose of this platform study is to evaluate the effect of anti-inflammatory agents on cognition in early Alzheimer's disease. Additionally, the safety and tolerability of these anti-inflammatory agents and the effects on central and peripheral inflammation will be evaluated.

Clinical Trial Description

This is a randomized, placebo-controlled, participant- and investigator-blinded study in participants with either mild cognitive impairment or mild Alzheimer's disease with evidence of peripheral inflammation. This study is using a platform design to be able to investigate different agents (therapies) in a perpetual manner. Each unique investigational agent will have a unique cohort of participants assigned. New cohorts of participants may be enrolled to investigate additional agents at unspecified timepoints throughout the study.

There are three periods in the study: screening period of 60 days that includes a baseline period of 7 days, a treatment period (20 weeks) and a follow-up period (28 days) and an additional follow-up visit for therapies with a longer washout. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

• NCT number: NCT04795466
• Study type: Interventional
• Source: Novartis
• Status: Terminated
• Phase: Phase 2
• Start date: October 28, 2021
• Completion date: March 7, 2024