APOLLOE4-LTE

TerminatedPhase 3

Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects

Long-term Extension of a Phase 3, Multicenter, Randomized, Double-Blind, Placebo- Controlled Study of the Efficacy, Safety, and Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease and APOE4/4 Genotype

Lead sponsor

Alzheon Inc.

Asset

ALZ-801

Listed sites

Recruiting sites

Enrollment

163

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoints

•ADAS-Cog•Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAEs)•Primary imaging biomarker endpoint 1

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDALZ-801-AD351

NCT IDNCT06304883

Timeline

Milestones

Study first posted2024-03-12actual

Study start2024-04-02actual

Primary completion2026-03-11actual

Study completion2026-03-11actual

Last update posted2026-06-25actual

Assets

Drug assets

ALZ-801

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subject has completed the Week 78 of the Phase 3 core study (ALZ-801-AD301) while on study drug.

•Subject has a reliable study partner who has sufficient contact with the subject to be able to provide accurate information about the subject's cognitive and functional abilities

Exclusion criteria

•Significant worsening of medical conditions that may preclude completion of this study.

•Evidence of symptomatic or new moderate-severe radiologic ARIA at baseline.

•Has received (or plans to receive) amyloid antibodies since completing Phase 3 core study (ALZ-801-AD301).

•Subject taking any prohibited medications per protocol.

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Neuroimaging

Function / daily living

Behavior / neuropsychiatric

Neurodegeneration biomarkers

Safety / tolerability / PK

Other (unclassified)

Global cognition

4 endpoints

Primary/protocol endpoint

Primary cognitive efficacy endpoint 1

Time frame:Week 104

ADAS-Cog

change from baseline, improvement

Primary/protocol endpoint

Primary cognitive efficacy endpoint 2

Time frame:Week 104

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Secondary global assessment efficacy endpoint

Time frame:Week 104

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Secondary cognitive efficacy endpoint 3

Time frame:Week 104

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

2 endpoints

Secondary/protocol endpoint

Secondary functional efficacy endpoint

Time frame:Week 104

change from baseline, improvement

Secondary/protocol endpoint

Secondary functional efficacy endpoint

Time frame:Week 104

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Secondary cognitive efficacy endpoint 2

Time frame:Week 104

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Neurodegeneration biomarkers

1 endpoint

Secondary/protocol endpoint

Secondary fluid biomarker endpoint

Time frame:Week 104

Phosphorylated tau 181 (p-tau181)

change from baseline, improvement

Neuroimaging

3 endpoints

Primary/protocol endpoint

Primary imaging biomarker endpoint 1

Time frame:Week 104

change from baseline, improvement

Primary/protocol endpoint

Primary imaging biomarker endpoint 2

Time frame:Week 104

change from baseline, improvement

Secondary/protocol endpoint

Secondary imaging biomarker endpoint

Time frame:Week 104

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAEs)

Time frame:Week 104

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Secondary cognitive efficacy endpoint 1

Time frame:Week 104

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.