Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Alzheimer's drug ALZ-801 tested Long-Term in High-Risk group

NCT ID NCT06304883

Disease control Sponsor: Alzheon Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the long-term safety and effects of ALZ-801, a tablet taken twice daily, in 163 people with early Alzheimer's disease who have the APOE4/4 gene. Participants had already completed a previous phase 3 study. The goal was to see if the drug could slow cognitive decline and brain shrinkage over two years. However, the study was terminated early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ALZ-801 (a tablet taken twice a day)
What this could lead to
If it works, this could point toward a treatment that slows cognitive decline and brain shrinkage in people with early Alzheimer's who have the APOE4/4 gene.
What could go wrong
This trial was terminated early, so results may be incomplete. It is an open-label extension, meaning everyone knows they are getting the drug, which can bias results. The drug may not show clear benefits or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

163 people

The number who actually took part.

Started

Apr 2024

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Early Alzheimer's disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Alzheimer disease central nervous system disorder cognitive disorder dementia nervous system disorder neurodegenerative disease psychiatric disorder tauopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early Alzheimer's disease

Contacts and locations

Locations

  • ALZ Research and Treatment Center (A.R.T.C.)

    Stuart, Florida, 34997, United States

  • ALZ Research and Treatment Center (A.R.T.C.)

    Wellington, Florida, 33414, United States

  • AMC Research

    Matthews, North Carolina, 28105, United States

  • ATP Clinical Research

    Costa Mesa, California, 92626, United States

  • Abington Neurological Associates

    Abington, Pennsylvania, 19001, United States

  • Advanced Memory Research Center

    Toms River, New Jersey, 08755, United States

  • Aqualane Clinical Research

    Naples, Florida, 34105, United States

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351, United States

  • Center for Cognitive Health

    Portland, Oregon, 97225, United States

  • Centricity Research

    Halifax, Nova Scotia, B3S 1N2, Canada

  • Charter Research

    Orlando, Florida, 32803, United States

  • Columbus Memory Center

    Columbus, Georgia, 31909, United States

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46804, United States

  • Headlands Research Eastern MA

    Plymouth, Massachusetts, 02360, United States

  • JEM Research Institute, Headlands Site

    Atlantis, Florida, 33462, United States

  • K2 Medical Research, LLC

    Maitland, Florida, 32751, United States

  • Kawartha Centre - Redefining Healthy Aging

    Peterborough, Ontario, K9H 2P4, Canada

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140, United States

  • NYU Alzheimer's Disease Research Center

    New York, New York, 10016, United States

  • NeuroClin Glasgow Ltd

    Motherwell, North Lanarkshire, ML1 4UF, United Kingdom

  • Neurological Associates of Albany

    Albany, New York, 12208, United States

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • OCT Research ULC (dba Okanagan Clinical Trials)

    Kelowna, British Columbia, V1Y 1Z9, Canada

  • Premiere Research Institute

    West Palm Beach, Florida, 33407, United States

  • Progressive Medical Research

    Port Orange, Florida, 32127, United States

  • Re-Cognition Health Ltd Birmingham

    Birmingham, West Midlands, B16 8LT, United Kingdom

  • Re-Cognition Health Ltd Bristol

    Bristol, BS32 4SY, United Kingdom

  • Re-Cognition Health Ltd Guildford

    Guildford, Surrey, GU2 7YD, United Kingdom

  • Re-Cognition Health Ltd London

    London, Greater London, W1G 9JF, United Kingdom

  • Re-Cognition Health Ltd Plymouth

    Plymouth, Devon, PL6 8BT, United Kingdom

  • Re-Cognition Health Ltd Winchester

    Winchester, SO21 1HU, United Kingdom

  • Re:Cognition Health

    Fairfax, Virginia, 22031, United States

  • Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic

    Ottawa, Ontario, K1Z 1G3, Canada

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914, United States

  • Sutter Health

    Sacramento, California, 95816, United States

  • Toronto Memory Program

    Toronto, Ontario, M3B 2S7, Canada

  • Torrance Clinical Research Institute

    Lomita, California, 90717, United States

  • Triad Clinical Trials

    Greensboro, North Carolina, 27410, United States

  • UT Health Science Center at Houston

    Houston, Texas, 77054, United States

  • University of Rochester Medical Center

    Rochester, New York, 14620, United States

  • Xenoscience, Inc.

    Phoenix, Arizona, 85004, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.