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