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ALZN002 · 1 trial · 1 indication
Frequency and severity of TEAEs
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | ALZN002 (autologous DCs pulsed with E22W mutant peptide). |
| Placebo | PLACEBO_COMPARATOR | Saline ID and IV administrations. |
| Name | Type | Description |
|---|---|---|
| ALZN002 (autologous DCs pulsed with E22W mutant peptide). | BIOLOGICAL | 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. |
| Placebo | DRUG | Saline |
Inclusion Criteria: Potential study subjects must satisfy the following criteria to be randomized in the study: 1. Age ≥60 and ≤85 years with no restrictions on gender, race, or ethnicity. 2. Able and willing to give informed consent and adhere to study requirements, including testing for cognitiv...
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ALZN002 is being developed for the treatment of Alzheimer disease. It is an investigational therapy being studied in patients with mild-to-moderate Alzheimer's dementia. It has not been approved for any indication and remains in clinical development.
ALZN002 targets amyloid-beta, a protein that accumulates in the brains of Alzheimer disease patients. It is described as autologous dendritic cells pulsed with an E22W mutant peptide, a cell-based approach directed at the amyloid-beta target. It is designed to stimulate an immune response against amyloid-beta.
ALZN002 is being developed by Alzamend Neuro, Inc., which trades under the ticker ALZN. The company is the sponsor advancing this asset through clinical development for Alzheimer disease.
ALZN002 is in Phase 1 clinical development. It is an investigational therapy and has not received FDA approval. The Phase 1 program is evaluating the therapy in patients with mild-to-moderate Alzheimer's dementia.
ALZN002 is being evaluated in a single Phase 1 trial, NCT05834296, titled Study in Subjects With Mild-to-Moderate Alzheimer's Dementia. The trial is active but not recruiting, enrolled 30 participants, is randomized, double-blind, and placebo-controlled, and is conducted in the United States.