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

Recruiting in Palo Alto (17 mi)

+143 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.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study is being conducted to evaluate the safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is a double-blind, randomized trial with one dose of ALZ-801 compared to placebo.

Research Team

Susan Abushakra, MD

Principal Investigator

Alzheon Inc.

Eligibility Criteria

This trial is for people with early Alzheimer's disease who have two copies of the APOE4 gene. They should show memory loss over the past year and have specific scores on cognitive tests like MMSE and CDR. People can't join if they've had recent strokes, seizures (except childhood febrile seizures), other brain disorders, major depression in the last year, or are taking certain dementia medications.

Inclusion Criteria

You have experienced worsening memory loss in the past year, according to the doctor's evaluation.

I have two copies of the APOE4 gene variant.

MMSE score at Screening of 22 to 30 (inclusive).

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Exclusion Criteria

I had a stroke or a mini-stroke in the last year.

I have not had seizures, except for childhood febrile ones or a single event over 5 years ago.

I am currently taking memantine or have taken it in the last 12 weeks.

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Treatment Details

Interventions

ALZ-801 (Small Molecule)

Trial OverviewThe study compares ALZ-801 to a placebo in individuals with early-stage Alzheimer's and the APOE4/4 genotype. Participants won't know which treatment they're getting as it's a double-blind trial where one group receives ALZ-801 and another gets an inactive substance.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ALZ-801Experimental Treatment1 Intervention

ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.

Group II: PlaceboPlacebo Group1 Intervention

Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study