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NCT05834296

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

Active, enrolled Phase 1, PHASE2 Last updated 2 September 2025
What this trial tests

Phase 1, PHASE2 trial testing ALZN002 (autologous DCs pulsed with E22W mutant peptide). in Alzheimer Disease in 30 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
5 July 2023
Primary endpoint
3 March 2028
3 March 2028

Quick facts

Lead sponsorAlzamend Neuro, Inc.
PhasePhase 1, PHASE2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment30
Start date5 July 2023
Primary completion3 March 2028
Estimated completion3 March 2028
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Alzamend Neuro, Inc. — full company profile →

Who can join

Adults 60 to 85, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Alzheimer's disease drug development pipeline: 2024.
    Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2024 · cited 209× · PMID 38659717 · DOI 10.1002/trc2.12465
  2. Recent Advances in Therapeutics for the Treatment of Alzheimer's Disease.
    Thawabteh AM, Ghanem AW, AbuMadi S, Thaher D, et al · · 2024 · cited 26× · PMID 39519769 · DOI 10.3390/molecules29215131
  3. Morphological and Molecular Profiling of Amyloid-β Species in Alzheimer's Pathogenesis.
    Almeida ZL, Vaz DC, Brito RMM. · · 2025 · cited 19× · PMID 39446217 · DOI 10.1007/s12035-024-04543-4
  4. Targeting Amyloid-β Proteins as Potential Alzheimer's Disease Therapeutics: Anti-Amyloid Drug Discovery, Emerging Therapeutics, Clinical Trials and Implications for Public Health.
    Abduljawad AA, Alkinani KB, Zaakan A, AlGhamdi AS, et al · · 2025 · cited 1× · PMID 41304975 · DOI 10.3390/ph18111731
  5. Decoding immunometabolism with next-generation tools: lessons from dendritic cells and T cells.
    Wang YH, Wang L, Ho PC. · · 2025 · cited 1× · PMID 40957982 · DOI 10.1038/s44318-025-00569-z

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05834296.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing