Study in Subjects With Mild-to-Moderate Alzheimer's Dementia

Alzheimer Disease Clinical Trial

Official title: Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 1/2a Study to Assess Safety, Tolerability & Efficacy of Autologous Beta-Amyloid Mutant Peptide-pulsed Dendritic Cells in Subjects With Mild-to-Moderate Alzheimer's Dementia

Status Active, not recruiting

Clinical Trial Summary

ALZN002-01 is a first-in-human, randomized, double-blind, placebo-controlled, parallel-group, phase 1/2a study of autologous amyloid beta mutant peptide-pulsed dendritic cells (ALZN002) in subjects with mild-to-moderate dementia of the Alzheimer's type.

Clinical Trial Description

ALZN002-01 is a first-in-human, randomized, double-blind, placebo-controlled, parallel-group, phase 1/2a study. The primary purpose of this study is to assess the safety and tolerability of multiple ascending doses of ALZN002 compared with that of placebo in subjects with mild to moderate dementia of the Alzheimer's type (AD) and to determine the optimal dosage of ALZN002 that allows for induction of anti-amyloid-beta (Aβ) antibody responses while maintaining safety. The overall goal of this study is to determine an appropriate dose to use in a larger phase 2b study (ALZN002-02) where efficacy is the primary study purpose. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

• NCT number: NCT05834296
• Study type: Interventional
• Source: Alzamend Neuro, Inc.
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: July 5, 2023
• Completion date: March 3, 2028