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Alzheimer's vaccine trial aims to stop brain protein buildup

NCT ID NCT06544616

Disease control Sponsor: Janssen Pharmaceutica N.V., Belgium 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This phase 2 study tests a vaccine called JNJ-64042056 in 55 people with very early signs of Alzheimer's (no symptoms yet but tau buildup in the brain). The vaccine is designed to train the immune system to attack tau protein, which forms tangles in Alzheimer's. Participants receive either the vaccine or a placebo, and researchers use brain scans to see if the vaccine slows tau spread over time.

What this could mean

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

Active substance
JNJ-64042056 (a vaccine that trains the immune system to attack a protein called tau in the brain)
What this could lead to
If it works, this could slow or stop the buildup of tau protein in the brain, potentially delaying or preventing Alzheimer's symptoms in people at high risk.
What could go wrong
This is a small, early-phase trial (55 people) testing safety and immune response, not yet proven to help memory or thinking. The vaccine may not work or could cause side effects like brain inflammation.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

55 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

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

55 to 75 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: * Elevated brain tau pathology defined as Braak 3 region of interest standardized uptake value ratio (ROI SUVR) greater than (\>) 1.1 (or equivalent based on emerging data) on a screening tau PET scan, reviewed centrally by a qualified reader to enrich for probability of disease progression during the study * Clinical Dementia Rating (CDR) global score of 0 at screening and baseline * Mini Mental State Examination (MMSE) greater than or equal to (\>=) 27 (with educational adjustment) at screening * Able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening * A participant must be of non-childbearing potential Exclusion Criteria: * History consistent with or known autosomal dominant AD (mutation identified in the family and/or participant) * Fulfills diagnostic criteria for Alzheimer's Dementia or non-Alzheimer's Dementia, including, but not limited to Frontotemporal Dementia (FTD), Diffuse Lewy Body Dementia (DLBD), Vascular Dementia (VAD), alcoholic dementia, Parkinson's dementia, Korsakov, Creutzfeldt-Jakob or other prion diseases, Posterior Cortical Atrophy * Diagnosis of Mild Cognitive Impairment (MCI) * Vitamin B12 or folate levels below the central laboratory lower limit of normal, unless the investigator determines that supplementation is not required after randomization * History of or current neurological disease other than preclinical AD that may make interpretation of possible new neurological signs or symptoms difficult

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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.

Alzheimer disease Preclinical Alzheimer's disease

Contacts and locations

Locations

  • AMC Research, LLC

    Matthews, North Carolina, 28105, United States

  • Alzheimers Research Australia

    Nedlands, 6009, Australia

  • Alzheimers Research and Treatment Center Stuart

    Stuart, Florida, 34997, United States

  • Alzheimers Research and Treatment Center Wellington

    Wellington, Florida, 33414, United States

  • Artemis Institute for Clinical Research Riverside

    Riverside, California, 92503, United States

  • Artemis Institute for Clinical Research San Diego

    San Diego, California, 92123, United States

  • Austin Health Heidelberg Repatriation Hospital

    Ivanhoe, 3079, Australia

  • Az Groeninge

    Kortrijk, 8500, Belgium

  • Barcelona Beta Brain Research Center

    Barcelona, 08005, Spain

  • Butler Hospital

    Providence, Rhode Island, 02906, United States

  • CHRU Tours Hopital Bretonneau

    Tours, 37000, France

  • CHU Pitie Salpetriere

    Paris, 75013, France

  • CHU Toulouse - Hôpital La Grave

    Toulouse, 31059, France

  • Centro At. Esp. Oroitu

    Getxo, 48993, Spain

  • Charter Research

    The Villages, Florida, 32162, United States

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Clinical NeuroScience Solutions Inc

    Jacksonville, Florida, 32256, United States

  • Clinical Trials of Texas Inc

    San Antonio, Texas, 78229, United States

  • Enomoto Internal Medicine Clinic

    Chofu-shi, 1820036, Japan

  • Esperanza Clinical

    Murrieta, California, 92562, United States

  • Excel Medical Clinical Trials, LLC

    Boca Raton, Florida, 33434, United States

  • Fund. Ace-Inst. Cat. Neuroc. Aplicades

    Barcelona, 08028, Spain

  • Great Lakes Clinical Trials Chicago

    Chicago, Illinois, 60640, United States

  • Great Lakes Clinical Trials Gurnee

    Gurnee, Illinois, 60031, United States

  • Hatsuta Neurology Clinic

    Hirakata-shi, 573-1121, Japan

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401, United States

  • Headlands Research Orlando

    Orlando, Florida, 32806, United States

  • Higashi-Shinjuku Clinic

    Shinjuku-ku, 169-0072, Japan

  • Hopital Lariboisiere-Fernand Widal

    Paris, 75010, France

  • Hopital Nord Laennec CHU NANTES

    Nantes, 44800, France

  • Hopital Roger Salengro - CHU Lille

    Lille, 59037, France

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp. Clinico San Carlos

    Madrid, 28040, Spain

  • Hosp. Mutua Terrassa

    Terrassa, 08222, Spain

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223, Spain

  • Hosp. Univ. Santa Maria

    Lleida, 25198, Spain

  • Hosp. Viamed Montecanal

    Zaragoza, 50012, Spain

  • Idc Salud Hosp. Gral. de Catalunya

    Sant Cugat del Vallès, 08195, Spain

  • Irvine Clinical Research

    Irvine, California, 92614, United States

  • JEM Research LLC

    Atlantis, Florida, 33462, United States

  • Jinsenkai MI Clinic

    Toyonaka-shi, 5600004, Japan

  • K2 Medical Research Lady Lake

    Lady Lake, Florida, 32159, United States

  • K2 Medical Research Maitland

    Maitland, Florida, 32751, United States

  • K2 Medical Research Tampa

    Tampa, Florida, 33634, United States

  • K2 Medical Research Winter Garden

    Clermont, Florida, 34711, United States

  • KaRa Institute of Neurological Diseases

    Macquarie Park, 2113, Australia

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm, 14186, Sweden

  • Keystone Clinical Studies LLC

    Plymouth Meeting, Pennsylvania, 19462, United States

  • Kings College Hospital

    London, WC2R 2LS, United Kingdom

  • Kobe City Medical Center General Hospital

    Kobe, 650 0047, Japan

  • Kusunoki Clinic

    Kobe, 650-0044, Japan

  • Medical corporation Shinanokai Samoncho Clinic

    Shinjyuku Ku, 160 0017, Japan

  • Memory Clinic Inc

    Bennington, Vermont, 05201, United States

  • Merritt Island Medical Research, LLC

    Merritt Island, Florida, 32952, United States

  • Moorgreen Hospital Memory Assessment And Research Centre

    Southampton, S03 3JB, United Kingdom

  • Musashimurayama Hospital

    Musashimurayama, 208-0022, Japan

  • Nagomi Clinic

    Toyonaka-shi, 560-0004, Japan

  • Neuro Trials Victoria

    Carlton, 3053, Australia

  • Neurological Associates of Albany, PC

    Albany, New York, 12208, United States

  • OCROM Clinic

    Suita Shi, 565 0853, Japan

  • Palm Beach Neurology and Premier Research Institute

    West Palm Beach, Florida, 33407, United States

  • Quest Research Institute

    Farmington Hills, Michigan, 48334, United States

  • Re-Cognition Health Birmingham

    Birmingham, B16 8LT, United Kingdom

  • Re-Cognition Health Bristol

    Bristol, BS32 4SY, United Kingdom

  • Re-Cognition Health Guildford

    Guildford, GU2 7YD, United Kingdom

  • Re-Cognition Health London

    London, W1G 8TA, United Kingdom

  • Re-Cognition Health Plymouth

    Plymouth, PL6 8BT, United Kingdom

  • Re-Cognition Health Winchester

    Winchester, SO23 8SR, United Kingdom

  • Royal United Hospital

    Bath, BA1 3NG, United Kingdom

  • Saiseikai Narashino Hospital

    Narashino-shi, 275-8580, Japan

  • Scottish Brain Sciences

    Edinburgh, EH12 5PJ, United Kingdom

  • Skanes universitetssjukhus

    Malmö, 20502, Sweden

  • Southampton General Hospital

    Southampton, SO16 6YD, United Kingdom

  • Southern Neurology

    Kogarah, 2217, Australia

  • St Vincent's Centre for Applied Medical Research

    Darlinghurst, 2010, Australia

  • The Cognitive and Research Center of New Jersey LLC

    Springfield, New Jersey, 07081, United States

  • The Medical Research Network, LLC

    New York, New York, 10128, United States

  • The Prince Charles Hospital

    Chermside, 4032, Australia

  • ToCROM Clinic

    Shinjuku Ku, 160 0008, Japan

  • Tokyo Asbo Clinic

    Chūōku, 104-0031, Japan

  • Universitaetsklinikum Koeln

    Cologne, 50937, Germany

  • Universitaetsklinikum der RWTH Aachen

    Aachen, 52074, Germany

  • Universitaetsklinikum des Saarlandes

    Homburg, 66421, Germany

  • Universitatsklinikum Munster

    Münster, 48149, Germany

  • University of Oxford

    Oxford, OX3 7JX, United Kingdom

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • Valley Medical Research

    Centerville, Ohio, 45459-2785, United States

  • Velocity Clinical Research East Syracuse

    East Syracuse, New York, 13057, United States

  • Xenoscience Inc.

    Phoenix, Arizona, 85004, United States

  • Yale University School Of Medicine

    New Haven, Connecticut, 06510, United States

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