Alzheimer’s disease · Drug research

ALZ-801

The registry reports completed. This is trial metadata, not an assessment of treatment benefit.

Content updated Oct 27, 2026 · Sources last checked Oct 27, 2026

Who was studied? Read the registry eligibility criteria

Inclusion Criteria: * Clinical diagnosis of MCI or Mild Dementia due to AD consistent with the National Institute on Aging-Alzheimer's Association (NIA-AA) Working Group Criteria. * Homozygous for the ε4 allele of the apolipoprotein E gene (APOE4/4). * MMSE score at Screening of 22 to 30 (inclusive). * CDR - Global score of 0.5 or 1 and CDR Memory Box Score of ≥ 0.5. * RBANS delayed memory index score ≤ 85. * Evidence of progressive memory loss over the last 12 months per investigator assessment Exclusion Criteria: * Brain magnetic resonance imaging (MRI) indicative of significant abnormality per central reader, other than AD related atrophy. Computed tomography (CT) scan acceptable for subjects who cannot undergo MRI. * Diagnosis of neurodegenerative disorder other than AD. * Diagnosis of major depressive disorder (MDD) within one year prior to screening. * Currently taking memantine or has taken memantine within 12 weeks prior to the Baseline Visit. * History of suicidal behavior within one year prior to screening or has ongoing suicidal ideation. * History of seizures, excluding febrile seizures of childhood or a single distant seizure (\> 5 years). * Medically confirmed history of recent cerebral infarct or transient ischemic attack within one year prior to screening.

This record covers only the linked trial population. This registry-based page does not review FDA approval or labeling.

Regulatory context

United States · FDA

FDA approval not reviewed here

Alzheimer’s disease

See FDA labeling for the approved population and indication; this page covers the trial population only.

FDA labeling has not been reviewed for this page. This does not mean the treatment is unapproved.

Approval is specific to the indication and population. It does not establish availability, reimbursement or suitability for an individual.

Clinical trials

An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects

This study has ended. Completion alone does not show that a treatment works.

Read trial record and posted results

Registry ID: NCT04770220
Phase: Phase 3
Recruitment: Completed
Sponsor: Alzheon Inc.
Design: Randomized
Comparator: ALZ-801; Placebo
Registry enrollment: 325
Endpoint: Primary Cognitive Efficacy Endpoint (ADAS-Cog13); Incidence, Nature, and Severity of Treatment Emergent Adverse Events (TEAE)

Study ages: 50 Years to 80 Years. Other eligibility criteria apply; see the full criteria above.

Study countries and territories (including sites that may be closed): Canada, Czechia, France, Germany, Iceland, Netherlands, Spain, United Kingdom, United States.

Primary data collection: May 29, 2024 (actual). This is not a results-release date.

Results posted Nov 10, 2025

Evidence 1

Evidence and limitations

Not assessed for clinical effectiveness

registry · Registry metadata is submitted by the sponsor or responsible party and does not independently validate efficacy.

Results are posted in the registry. Outcomes have not been appraised in this record.

Limitations: Outcomes, effect estimates, uncertainty and study quality have not been appraised. Consult original results and publications.

Evidence 1

Sources and verification

An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects

registry · NCT04770220 · Structured source fields

Source date: Sep 29, 2026 · Checked: Oct 27, 2026

Evidence location: protocolSection: identificationModule, statusModule, conditionsModule, armsInterventionsModule, designModule, outcomesModule, eligibilityModule, contactsLocationsModule, sponsorCollaboratorsModule; hasResults

Status: COMPLETED. Phase: PHASE3. Conditions: Early Alzheimer's Disease.

Open original source

Change history

Oct 27, 2026 — Initial registry evidence validated.