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New hope for Alzheimer's? drug targets High-Risk gene carriers

NCT ID NCT04770220

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 tested an experimental drug called ALZ-801 in 325 people with early Alzheimer's disease who carry two copies of the APOE4 gene, a strong risk factor. Participants received either the drug or a placebo for a year. Researchers measured changes in memory, thinking, and daily living skills, and tracked side effects to see if the drug is safe and slows the disease.

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

325 people

The number who actually took part.

Started

May 2021

Finished

Jul 2024

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 80 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: * 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). * MMSE score at Screening of 22 to 30 (inclusive). * CDR - Global score of 0.5 or 1 and CDR Memory Box Score of ≥ 0.5. * RBANS delayed memory index score ≤ 85. * Evidence of progressive memory loss over the last 12 months per investigator assessment Exclusion Criteria: * Brain magnetic resonance imaging (MRI) indicative of significant abnormality per central reader, other than AD related atrophy. Computed tomography (CT) scan acceptable for subjects who cannot undergo MRI. * Diagnosis of neurodegenerative disorder other than AD. * Diagnosis of major depressive disorder (MDD) within one year prior to screening. * Currently taking memantine or has taken memantine within 12 weeks prior to the Baseline Visit. * History of suicidal behavior within one year prior to screening or has ongoing suicidal ideation. * History of seizures, excluding febrile seizures of childhood or a single distant seizure (\> 5 years). * Medically confirmed history of recent cerebral infarct or transient ischemic attack within one year prior to screening.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

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

  • Advanced Research Consultants

    Palm Beach Gardens, Florida, 33410, United States

  • Alphab Global Research

    Jupiter, Florida, 33458, United States

  • Aqualane Clinical Research

    Naples, Florida, 34105, United States

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351, United States

  • Bradenton Research Center

    Bradenton, Florida, 34205, United States

  • Brain Research Center Amsterdam

    Amsterdam, 1081 GN, Netherlands

  • Brain Research Center Den Bosch

    's-Hertogenbosch, 5223 LA, Netherlands

  • Brain Research Center Zwolle

    Zwolle, 8025 AZ, Netherlands

  • CCT Research

    Scottsdale, Arizona, 85297, United States

  • Center for Cognitive Health

    Portland, Oregon, 97225, United States

  • Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen

    Rouen, 76031, France

  • Centre Hospitalier Universitaire de Marseille - Hôpital de la Timone

    Marseille, 13385, France

  • Centre de Recherche Clinique du Gerontopole - CHU Toulouse

    Toulouse, 31059, France

  • Centre de Recherche-Hopital Geriatrique de Charpennes

    Villeurbanne, 69100, France

  • Centricity Research

    Halifax, Nova Scotia, B3S 1N2, Canada

  • Centricity Research

    New Minas, Nova Scotia, B4N 3R7, Canada

  • Centro Hospital Universitario Dr. Preset

    Valencia, 46017, Spain

  • Charter Research

    Lady Lake, Florida, 32159, United States

  • Charter Research

    Orlando, Florida, 32803, United States

  • Clinica Universidad de Navarra

    Madrid, 28027, Spain

  • Clinica Universidad de Navarra

    Pamplona, 31008, Spain

  • Collaborative NeuroScience Network LLC

    Long Beach, California, 90806, United States

  • Columbus Memory Center

    Columbus, Georgia, 31909, United States

  • Fakultní nemocnice u sv. Anny v Brně (St. Anne's University Hospital)

    Brno, 656 91, Czechia

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46804, United States

  • Fundacia ACE - Institut Catala de Neurociencies Aplicadas

    Barcelona, 08028, Spain

  • Galiz Research

    Hialeah, Florida, 33016, United States

  • Headlands Research Eastern MA

    Plymouth, Massachusetts, 02360, United States

  • Headlands Research Orlando

    Orlando, Florida, 32819, United States

  • Hopital Gui de Chauliac - CHRU de Montpellier

    Montpellier, 43431, France

  • Hopital Lariboisiere - Fernand-Widal - AP-HP

    Paris, 75475, France

  • Hopitaux Universitaires de Strasbourg Centre d'Investigation Clinique

    Strasbourg, 67200, France

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitari MutuaTerrassa

    Terrassa, 08221, Spain

  • IPS Research

    Oklahoma City, Oklahoma, 73106, 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

  • Kline Institute for Psychiatric Research

    Orangeburg, New York, 10962, United States

  • Klinikum der Universitaet Muenchen Innenstadt

    München, 80336, Germany

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104, United States

  • Louisiana State University Health Sciences Center (LSUHSC)

    Shreveport, Louisiana, 71103, United States

  • Medica 111, Spol. s r.o. - Neurologicka a Rehabilitacni Ambulance Brno, Centralni Pracoviste v Brne

    Brno, 602 00, Czechia

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Memory Clinic, Landspitali University Hospital

    Reykjavik, 101, Iceland

  • Miami Jewish Health

    Miami, Florida, 33137, United States

  • 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

  • NeuroScience Research Center

    Canton, Ohio, 44718, United States

  • Neurological Associates of Albany

    Albany, New York, 12208, United States

  • Neurology Diagnostics, Inc.

    Dayton, Ohio, 45459, United States

  • Neuropsychiatrie s.r.o.

    Prague, 160 00, Czechia

  • 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

  • Quantum CNS Clinical Research

    Pompano Beach, Florida, 33064, United States

  • Re-Cognition Health Ltd Birmingham

    Birmingham, West Midlands, B16 8LT, 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

  • Re:Cognition Health Ltd Bristol

    Bristol, BS32 4SY, United Kingdom

  • Recherches Neuro-Hippocampe Inc. d/b/a Clinique de la Mémoire de l'Outaouais

    Gatineau, Quebec, J8T 8J1, Canada

  • 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

  • Richmond Behavioral Associates

    Staten Island, New York, 10312, United States

  • SC3 Research Group

    Pasadena, California, 91105, United States

  • Sandhill Research, LLC

    Decatur, Georgia, 30030, United States

  • St. Pancras Clinical Research

    London, EC2Y 8EA, United Kingdom

  • Stanford University

    Palo Alto, California, 94304, United States

  • Studienzentrum Nord-West

    Westerstede, 26655, Germany

  • Sutter Health

    Sacramento, California, 95816, United States

  • Tilda Research

    Irvine, California, 92780, 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

  • UCSD Shiley-Marcos Alzheimer's Disease Research Center

    La Jolla, California, 92037, United States

  • UT Health Science Center at Houston

    Houston, Texas, 77054, United States

  • University Hospital RWTH Aachen Neurological Study Center

    Aachen, 52074, Germany

  • University of Rochester Medical Center

    Rochester, New York, 14620, United States

  • Universitätsklinik fuer Psychiatrie und Psychotherapie

    Tübingen, 72076, Germany

  • Vanderbilt Center for Cognitive Medicine

    Nashville, Tennessee, 37212, United States

  • Vestra Clinics - Dedicated Research Clinics

    Rychnov nad Kněžnou, 51601, Czechia

  • WR-CRCN

    Las Vegas, Nevada, 89106, United States

  • Xenoscience

    Phoenix, Arizona, 85004, United States

  • Y & L Advance Health Care, Inc /DBA Elite Clinical Research

    Miami, Florida, 33144, United States

More trials for these conditions

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