Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects (APOLLOE4-LTE)

June 23, 2026 updated by: Alzheon Inc.

Long-term Extension of a Phase 3, Multicenter, Randomized, Double-Blind, Placebo- Controlled Study of the Efficacy, Safety, and Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease and APOE4/4 Genotype

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a long-term extension study of the Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and imaging biomarker effects of ALZ-801 in subjects with Early Alzheimer's Disease and APOE4/4 genotype. Subjects who at initial screening for the Phase 3 study were 50-80 years old, had a clinical diagnosis of AD, carried the APOE4/4 genotype, and were at the early stage of disease (Early AD], who complete at least 78 weeks of the Phase 3 study while on study medication, were eligible for enrollment. Subjects will be treated for 104 weeks with ALZ-801, followed by a 4-week safety follow-up visit after the last dose of ALZ-801. Clinical trial sites, subjects and their study partner will remain blinded to the treatment (ALZ-801 or placebo) that they received in the core Phase 3 study. The primary efficacy outcome assessment is a measure of cognition (ADAS-Cog 13). Additional measures of global and functional impairments will also be assessed. Imaging and biomarkers of AD and neurodegeneration will be measured.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
163

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • OCT Research ULC (dba Okanagan Clinical Trials)
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3S 1N2
        • Centricity Research
    • Ontario
      • Ottawa, Ontario, Canada, K1Z 1G3
        • Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic
      • Peterborough, Ontario, Canada, K9H 2P4
        • Kawartha Centre - Redefining Healthy Aging
      • Toronto, Ontario, Canada, M3B 2S7
        • Toronto Memory Program
  • United Kingdom
      • Bristol, United Kingdom, BS32 4SY
        • Re-Cognition Health Ltd Bristol
      • Winchester, United Kingdom, SO21 1HU
        • Re-Cognition Health Ltd Winchester
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8BT
        • Re-Cognition Health Ltd Plymouth
    • Greater London
      • London, Greater London, United Kingdom, W1G 9JF
        • Re-Cognition Health Ltd London
    • North Lanarkshire
      • Motherwell, North Lanarkshire, United Kingdom, ML1 4UF
        • NeuroClin Glasgow Ltd
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7YD
        • Re-Cognition Health Ltd Guildford
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B16 8LT
        • Re-Cognition Health Ltd Birmingham
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Xenoscience, Inc.
      • Sun City, Arizona, United States, 85351
        • Banner Sun Health Research Institute
    • California
      • Costa Mesa, California, United States, 92626
        • ATP Clinical Research
      • Lomita, California, United States, 90717
        • Torrance Clinical Research Institute
      • Sacramento, California, United States, 95816
        • Sutter Health
    • Florida
      • Atlantis, Florida, United States, 33462
        • JEM Research Institute, Headlands Site
      • Maitland, Florida, United States, 32751
        • K2 Medical Research, LLC
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Naples, Florida, United States, 34105
        • Aqualane Clinical Research
      • Orlando, Florida, United States, 32803
        • Charter Research
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
      • Stuart, Florida, United States, 34997
        • ALZ Research and Treatment Center (A.R.T.C.)
      • Wellington, Florida, United States, 33414
        • ALZ Research and Treatment Center (A.R.T.C.)
      • West Palm Beach, Florida, United States, 33407
        • Premiere Research Institute
    • Georgia
      • Columbus, Georgia, United States, 31909
        • Columbus Memory Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Neurological Center
    • Massachusetts
      • Plymouth, Massachusetts, United States, 02360
        • Headlands Research Eastern MA
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Advanced Memory Research Center
    • New York
      • Albany, New York, United States, 12208
        • Neurological Associates of Albany
      • New York, New York, United States, 10016
        • NYU Alzheimer's Disease Research Center
      • Rochester, New York, United States, 14620
        • University of Rochester Medical Center
    • North Carolina
      • Greensboro, North Carolina, United States, 27410
        • Triad Clinical Trials
      • Matthews, North Carolina, United States, 28105
        • AMC Research
    • Oregon
      • Portland, Oregon, United States, 97225
        • Center for Cognitive Health
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Neurological Associates
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Rhode Island Mood & Memory Research Institute
    • Texas
      • Houston, Texas, United States, 77054
        • UT Health Science Center at Houston
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Re:Cognition Health
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject has completed the Week 78 of the Phase 3 core study (ALZ-801-AD301) while on study drug.
  • Subject has a reliable study partner who has sufficient contact with the subject to be able to provide accurate information about the subject's cognitive and functional abilities.

Exclusion Criteria:

  • Significant worsening of medical conditions that may preclude completion of this study.
  • Evidence of symptomatic or new moderate-severe radiologic ARIA at baseline.
  • Has received (or plans to receive) amyloid antibodies since completing Phase 3 core study (ALZ-801-AD301).
  • Subject taking any prohibited medications per protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: ALZ-801
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.
Drug: Experimental: ALZ-801
ALZ-801 265 mg BID tablet orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary cognitive efficacy endpoint 1
Time Frame: Week 104
Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog 13), from baseline of Phase 3 core study (ALZ-801-AD301) to Week 52 and Week 104 of this long-term extension study (ALZ-801-AD351).
Week 104
Primary cognitive efficacy endpoint 2
Time Frame: Week 104
Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog 13), from baseline of this study to Week 52 and Week 104.
Week 104
Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAEs)
Time Frame: Week 104
Safety and tolerability as measured by incidence, nature and severity of treatment emergent adverse events (TEAE), serious TEAE, and TEAE leading to withdrawal.
Week 104
Primary imaging biomarker endpoint 1
Time Frame: Week 104
Change from baseline in total hippocampal volume (mm3) as measured by Magnetic Resonance Imaging (MRI), from baseline of the Phase 3 core study (ALZ-801-AD301) to Week 52 and Week 104 of this long-term extension study (ALZ-801-AD351).
Week 104
Primary imaging biomarker endpoint 2
Time Frame: Week 104
Change from baseline in total hippocampal volume (mm3) as measured by Magnetic Resonance Imaging (MRI), from baseline of this study to Week 52 and Week 104.
Week 104

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary functional efficacy endpoint
Time Frame: Week 104
Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study, in Disability Assessment for Dementia scores.
Week 104
Secondary functional efficacy endpoint
Time Frame: Week 104
Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study, in Amsterdam - Instrumental Activities of Daily Living scores.
Week 104
Secondary global assessment efficacy endpoint
Time Frame: Week 104
Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study, in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores.
Week 104
Secondary cognitive efficacy endpoint 1
Time Frame: Week 104
Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study, in Alzheimer's Disease Assessment Scale - Cognitive Subscale 11.
Week 104
Secondary cognitive efficacy endpoint 2
Time Frame: Week 104
Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study, in Neuropsychiatric Inventory.
Week 104
Secondary cognitive efficacy endpoint 3
Time Frame: Week 104
Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study, in Mini-Mental State Examination.
Week 104
Secondary imaging biomarker endpoint
Time Frame: Week 104
Change from baseline of the Phase 3 core study (ALZ-801-AD301) and from baseline of this long-term extension study (ALZ-801-AD351) in cortical thickness, whole brain volume and ventricular volume (mm3) as measured by Magnetic Resonance Imaging (MRI) to Weeks 26, 52, 78 and 104.
Week 104
Secondary fluid biomarker endpoint
Time Frame: Week 104
Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study in plasma p-tau181, Aβ 42, Aβ 40, GFAP, and NfL levels.
Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alzheon Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Susan Abushakra, MD, Alzheon Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 11, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 11, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALZ-801-AD351

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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