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Anti-amyloid agent

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

Phase 3
Waitlist Available
Led By Susan Abushakra, MD
Research Sponsored by Alzheon Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights

Summary

"This trial is looking at how safe and effective ALZ-801 is for people with Early Alzheimer's disease who have a specific genetic marker. Participants will receive treatment with ALZ-801 in an open

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Specific side effects aren't listed here, but typically for Alzheimer's treatments, one might expect gastrointestinal issues, dizziness, headaches or even mood changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAEs)
Primary cognitive efficacy endpoint 1
Primary cognitive efficacy endpoint 2
+2 more
Secondary study objectives
Secondary cognitive efficacy endpoint 1
Secondary cognitive efficacy endpoint 2
Secondary cognitive efficacy endpoint 3
+4 more

Trial Design

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.

Find a Location

Who is running the clinical trial?

Alzheon Inc.Lead Sponsor
4 Previous Clinical Trials
444 Total Patients Enrolled
Susan Abushakra, MDPrincipal InvestigatorAlzheon Inc.
1 Previous Clinical Trials
300 Total Patients Enrolled
~190 spots leftby Dec 2025
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