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The trial is taking place at:
A

ATP Clinical Research, Inc. | Costa Mesa, CA

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

A

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)

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

Trial contacts and locations

61

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Central trial contact

Aidan Power, MB MRCPsych

Data sourced from clinicaltrials.gov

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