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Thymogen

Glu-Trp, EW dipeptide, Oglufanide, L-Glutamyl-L-tryptophan

Quick Stats
Studies 94
Trials 51
Active Not Recruiting PHASE1, PHASE2 INTERVENTIONAL NCT05834296

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

Name: ALZN002 (autologous DCs pulsed with E22W mutant peptide).
Type: BIOLOGICAL
Description: The cellular immunotherapy product consists of autologous dendritic cells (DCs) pulsed with a novel amyloid-beta peptide (Aβ1 42) containing a mutation at position 22 from glutamic acid to tryptophan (E22W). This mutation produces novel CD4+ T cell epitopes specific for the mutant E22W peptide that can facilitate an anti-Aβ1-42 antibody response. The activated E22W peptide specific CD4+ T cells license Aβ1-42-specific B cells to secrete anti Aβ1-42 antibodies, resulting in systemic reduction of amyloid and reduction or slowed accumulation of amyloid plaques in the brain.
Name: Placebo
Type: DRUG
Description: Saline

Primary Outcomes

Measure: TEAEs
TimeFrame: Through study completion, up to 33 months
Description: Frequency and severity of TEAEs

Trial Information

NCT ID

NCT05834296

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE1, PHASE2

Sponsor

Alzamend Neuro, Inc.

Last Updated

December 15, 2025