ALZ-801 for Early Alzheimer's Disease
(APOLLOE4-LTE Trial)

Recruiting in Palo Alto (17 mi)

+71 other locations

Overseen bySusan Abushakra, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alzheon Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for people with early-stage Alzheimer's disease who have a specific genetic makeup (APOE4/4 genotype). It's an extension of a previous study, so participants likely need to have been involved in that earlier phase.

Inclusion Criteria

I have someone who can accurately report on my mental and physical abilities.

I completed Week 78 of the ALZ-801-AD301 study while taking the medication.

Exclusion Criteria

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

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

I have new or worsening brain swelling or bleeding shown in scans.

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Treatment Details

Interventions

ALZ-801 (Anti-amyloid agent)

Trial OverviewThe trial is testing the long-term effects of ALZ-801 on patients. Since it's open-label, everyone knows they're getting the experimental drug and there’s no placebo group.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Experimental: ALZ-801Experimental Treatment1 Intervention

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.