TerminatedPhase 3

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

Stopped: Sponsor business decision

United States, Canada, United Kingdom163 participantsStarted 2024-04-02

Plain-language 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.

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary cognitive efficacy endpoint 1

Timeframe: Week 104

Primary cognitive efficacy endpoint 2

Timeframe: Week 104

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

Timeframe: Week 104

Primary imaging biomarker endpoint 1

Timeframe: Week 104

Primary imaging biomarker endpoint 2

Timeframe: Week 104

Trial details

NCT IDNCT06304883

SponsorAlzheon Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-11

View on ClinicalTrials.gov More Early Alzheimer's Disease trials

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Primary cognitive efficacy endpoint 1

Timeframe: Week 104

Primary cognitive efficacy endpoint 2

Timeframe: Week 104

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

Timeframe: Week 104

Primary imaging biomarker endpoint 1

Timeframe: Week 104

Primary imaging biomarker endpoint 2

Timeframe: Week 104