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

Palo Alto (17 mi)

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.

Treatment Details

The 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.

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.