Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects (APOLLOE4-LTE)

Alzheon

Status and phase: Invitation-only; Phase 3

Conditions: Early Alzheimer's Disease

Treatments: Drug: Experimental: ALZ-801

Study type: Interventional

Funder types: Industry

Identifiers

NCT06304883

ALZ-801-AD351

Details and patient eligibility

About

This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801.

Full description

This is a long-term extension study of the Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and imaging biomarker effects of ALZ-801 in subjects with Early Alzheimer's Disease and APOE4/4 genotype. Subjects who at initial screening for the Phase 3 study were 50-80 years old, had a clinical diagnosis of AD, carried the APOE4/4 genotype, and were at the early stage of disease (Early AD], who complete at least 78 weeks of the Phase 3 study while on study medication, are eligible for enrollment. Subjects will be treated for 52 weeks with ALZ-801, followed by a 4-week safety follow-up visit after the last dose of ALZ-801. Clinical trial sites, subjects and their study partner will remain blinded to the treatment (ALZ-801 or placebo) that they received in the core Phase 3 study. The primary efficacy outcome assessment is a measure of cognition (ADAS-Cog 13). Additional measures of global and functional impairments will also be assessed. Imaging and biomarkers of AD and neurodegeneration will be measured.

Enrollment: 285 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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285 participants in 1 patient group

Experimental: ALZ-801

Experimental group

Description:

ALZ-801 265 mg BID tablet orally. Subjects will take one 265 mg tablet of ALZ-801 in the evening during the first 4 weeks of the study; thereafter, they will take one 265 mg tablet BID.

Treatment:

Drug: Experimental: ALZ-801