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

NCT ID: NCT06304883

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-02
• Study Completion Date: 2027-01-31

Brief Summary

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.

Detailed 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, were eligible for enrollment. Subjects will be treated for 104 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.

Conditions

Early Alzheimer's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: ALZ-801

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.

Group Type: EXPERIMENTAL

Experimental: ALZ-801

Intervention Type: DRUG

ALZ-801 265 mg BID tablet orally.

Interventions

Experimental: ALZ-801

ALZ-801 265 mg BID tablet orally.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alzheon Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Abushakra, MD

Role: PRINCIPAL_INVESTIGATOR

Alzheon Inc.

Locations

Xenoscience, Inc.

Phoenix, Arizona, United States

Banner Sun Health Research Institute

Sun City, Arizona, United States

ATP Clinical Research

Costa Mesa, California, United States

Torrance Clinical Research Institute

Lomita, California, United States

Sutter Health

Sacramento, California, United States

JEM Research Institute, Headlands Site

Atlantis, Florida, United States

K2 Medical Research, LLC

Maitland, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Aqualane Clinical Research

Naples, Florida, United States

Charter Research

Orlando, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

ALZ Research and Treatment Center (A.R.T.C.)

Stuart, Florida, United States

ALZ Research and Treatment Center (A.R.T.C.)

Wellington, Florida, United States

Premiere Research Institute

West Palm Beach, Florida, United States

Columbus Memory Center

Columbus, Georgia, United States

Fort Wayne Neurological Center

Fort Wayne, Indiana, United States

Headlands Research Eastern MA

Plymouth, Massachusetts, United States

Advanced Memory Research Center

Toms River, New Jersey, United States

Neurological Associates of Albany

Albany, New York, United States

NYU Alzheimer's Disease Research Center

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Triad Clinical Trials

Greensboro, North Carolina, United States

AMC Research

Matthews, North Carolina, United States

Center for Cognitive Health

Portland, Oregon, United States

Abington Neurological Associates

Abington, Pennsylvania, United States

Rhode Island Mood & Memory Research Institute

East Providence, Rhode Island, United States

UT Health Science Center at Houston

Houston, Texas, United States

Re:Cognition Health

Fairfax, Virginia, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

OCT Research ULC (dba Okanagan Clinical Trials)

Kelowna, British Columbia, Canada

Centricity Research

Halifax, Nova Scotia, Canada

Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic

Ottawa, Ontario, Canada

Kawartha Centre - Redefining Healthy Aging

Peterborough, Ontario, Canada

Toronto Memory Program

Toronto, Ontario, Canada

Re-Cognition Health Ltd Plymouth

Plymouth, Devon, United Kingdom

Re-Cognition Health Ltd London

London, Greater London, United Kingdom

NeuroClin Glasgow Ltd

Motherwell, North Lanarkshire, United Kingdom

Re-Cognition Health Ltd Guildford

Guildford, Surrey, United Kingdom

Re-Cognition Health Ltd Birmingham

Birmingham, West Midlands, United Kingdom

Re-Cognition Health Ltd Bristol

Bristol, , United Kingdom

Re-Cognition Health Ltd Winchester

Winchester, , United Kingdom

Countries

United States; Canada; United Kingdom

Other Identifiers

ALZ-801-AD351

Identifier Type: -

Identifier Source: org_study_id