← Back to Search

Small Molecule

ALZ-801 for Alzheimer's Disease (APOLLOE4 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
Clinical diagnosis of MCI or Mild Dementia due to AD consistent with the National Institute on Aging-Alzheimer's Association (NIA-AA) Working Group Criteria.
Homozygous for the ε4 allele of the apolipoprotein E gene (APOE4/4).
Timeline
Screening 28 days
Treatment 12 weeks
Follow Up 30 days
Awards & highlights

APOLLOE4 Trial Summary

This trial is testing a potential Alzheimer's treatment in people with a specific gene type. It is double-blind, meaning neither the participants nor the researchers know who is receiving the treatment or the placebo.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
While specific side effects for ALZ-801 aren't provided here, common side effects in trials like this may include gastrointestinal issues, headaches, dizziness, or allergic reactions. The safety profile will be closely monitored throughout the study.

APOLLOE4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with early Alzheimer's disease.
Select...
I have two copies of the APOE4 gene variant.

APOLLOE4 Trial Timeline

Screening ~ 28 days
Treatment ~ 12 weeks
Follow Up ~30 days
This trial's timeline: 28 days for screening, 12 weeks for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAE)
Primary cognitive efficacy endpoint
Primary fluid biomarker endpoint 1
+2 more
Secondary outcome measures
Functional assessment 1
Functional assessment 2
Global assessment

APOLLOE4 Trial Design

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

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,668 Previous Clinical Trials
28,004,764 Total Patients Enrolled
Alzheon Inc.Lead Sponsor
4 Previous Clinical Trials
429 Total Patients Enrolled
Susan Abushakra, MDPrincipal InvestigatorAlzheon Inc.
1 Previous Clinical Trials
285 Total Patients Enrolled

Media Library

ALZ-801 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04770220 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research involve patients that are above the age of 75?

"This study is looking for individuals that are in their 50s or older but no more than 80 years old."

Answered by AI

Is it possible to join this research project at this time?

"That is correct, the clinicaltrials.gov website does show that this trial is looking for enrollees. The posted date was May 19th, 2021 and the last update was on August 18th, 2022. They are hoping to have 300 people sign up at 70 different locations."

Answered by AI

Can you tell me how many research facilities are participating in this project?

"There are 70 running for this trial such as Quantum Laboratories in Pompano Beach, Lehigh Center for Clinical Research in Allentown, and Headlands Research Orlando in Orlando,to name a few other locations."

Answered by AI

Does the FDA sanction using ALZ-801 in medical treatments?

"Experimental: ALZ-801 received a safety score of 3 because there is some efficacy data and multiple rounds of safety data from Phase 3 trials."

Answered by AI

How many volunteers are needed for this research project?

"In order to run this study, the research team needs to enroll 300 individuals that fit the pre-determined participant criteria. Those interested in taking part of this trial can do so at Quantum Laboratories (Pompano Beach, Florida) or Lehigh Center for Clinical Research (Allentown, Pennsylvania)."

Answered by AI

Who is eligible to take part in this experiment?

"Eligible patients for this Alzheimer's disease treatment clinical trial must be aged 50-80. A total of 300 individuals will be accepted into the study."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Pennsylvania
California
Other
How old are they?
65+
18 - 65
What site did they apply to?
Banner Sun Health Research Institute
Mount Sinai Medical Center
SC3 Research Group
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
0

Why did patients apply to this trial?

I have MCI and it is worsening. Need help. No success with other trials. I am very interested in brain health overall.
PatientReceived 2+ prior treatments
I've been in one before that was cancelled. Covid happened and he was no more testing. Ice wanted to get into about one.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long do screenings take, and where are the screenings done?
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. SC3 Research Group: < 48 hours
  2. NeuroScience Research Center: < 48 hours
Typically responds via
Email
Phone Call
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects
2021. "An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04770220.
All > Alzheimers Disease Miami
~8 spots leftby May 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top