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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 5, 2023

Primary Completion Date

March 3, 2028

Study Completion Date

March 3, 2028

Conditions
Alzheimer Disease
Interventions
BIOLOGICAL

ALZN002 (autologous DCs pulsed with E22W mutant peptide).

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.

DRUG

Placebo

Saline

Trial Locations (1)

33186

First Excellent Research Group, Doral

Sponsors
All Listed Sponsors
collaborator

bioRASI, LLC

INDUSTRY

lead

Alzamend Neuro, Inc.

INDUSTRY

NCT05834296 - Study in Subjects With Mild-to-Moderate Alzheimer's Dementia | Biotech Hunter | Biotech Hunter