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Alzheimer DiseasePhase 2ReτainNCT06544616

A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease

A Phase 2 study testing JNJ-64042056 in people with Alzheimer Disease, run by Janssen Pharmaceutica N.V., Belgium at 90 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to assess whether JNJ-64042056 affects the spread and build up of tau (a protein in brain) when compared with placebo, using brain scan (tau PET) to determine results from specific areas of the brain. Read more about this study

Who is it for?
Ages 55 to 75 years
Conditions the study is for
Alzheimer Disease
What is being tested?
JNJ-64042056
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
90 sitesin 9 countries
Study dates
22 Jul 2024to 5 Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

90 sites in 9 countries.

90 sites in 9 countries

United States34 sites

  • Neurological Associates of Albany, PC

    Albany, New York, 12208

  • JEM Research LLC

    Atlantis, Florida, 33462

  • Memory Clinic Inc

    Bennington, Vermont, 05201

  • Excel Medical Clinical Trials, LLC

    Boca Raton, Florida, 33434

  • Valley Medical Research

    Centerville, Ohio, 45459-2785

  • University of Virginia

    Charlottesville, Virginia, 22903

  • Great Lakes Clinical Trials Chicago

    Chicago, Illinois, 60640

  • K2 Medical Research Winter Garden

    Clermont, Florida, 34711

  • Velocity Clinical Research East Syracuse

    East Syracuse, New York, 13057

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

  • Great Lakes Clinical Trials Gurnee

    Gurnee, Illinois, 60031

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Irvine Clinical Research

    Irvine, California, 92614

  • Clinical NeuroScience Solutions Inc

    Jacksonville, Florida, 32256

  • K2 Medical Research Lady Lake

    Lady Lake, Florida, 32159

  • K2 Medical Research Maitland

    Maitland, Florida, 32751

  • AMC Research, LLC

    Matthews, North Carolina, 28105

  • Merritt Island Medical Research, LLC

    Merritt Island, Florida, 32952

  • Esperanza Clinical

    Murrieta, California, 92562

  • Yale University School Of Medicine

    New Haven, Connecticut, 06510

  • The Medical Research Network, LLC

    New York, New York, 10128

  • Headlands Research Orlando

    Orlando, Florida, 32806

  • Xenoscience Inc.

    Phoenix, Arizona, 85004

  • Keystone Clinical Studies LLC

    Plymouth Meeting, Pennsylvania, 19462

  • Butler Hospital

    Providence, Rhode Island, 02906

  • Artemis Institute for Clinical Research Riverside

    Riverside, California, 92503

  • Clinical Trials of Texas Inc

    San Antonio, Texas, 78229

  • Artemis Institute for Clinical Research San Diego

    San Diego, California, 92123

  • The Cognitive and Research Center of New Jersey LLC

    Springfield, New Jersey, 07081

  • Alzheimers Research and Treatment Center Stuart

    Stuart, Florida, 34996

  • K2 Medical Research Tampa

    Tampa, Florida, 33634

  • Charter Research

    The Villages, Florida, 32162

  • Alzheimers Research and Treatment Center Wellington

    Wellington, Florida, 33414

  • Palm Beach Neurology and Premier Research Institute

    West Palm Beach, Florida, 33407

Other trials in United States

Japan13 sites

  • Enomoto Internal Medicine Clinic

    Chofu-shi, 1820036

  • Tokyo Asbo Clinic

    Chūōku, 104-0031

  • Hatsuta Neurology Clinic

    Hirakata-shi, 573-1121

  • Kobe City Medical Center General Hospital

    Kobe, 650 0047

  • Kusunoki Clinic

    Kobe, 650-0044

  • Musashimurayama Hospital

    Musashimurayama, 208-0022

  • Saiseikai Narashino Hospital

    Narashino-shi, 275-8580

  • ToCROM Clinic

    Shinjuku Ku, 160 0008

  • Higashi-Shinjuku Clinic

    Shinjuku-ku, 169-0072

  • Medical corporation Shinanokai Samoncho Clinic

    Shinjyuku Ku, 160 0017

  • OCROM Clinic

    Suita Shi, 565 0853

  • Nagomi Clinic

    Toyonaka-shi, 560-0004

  • Jinsenkai MI Clinic

    Toyonaka-shi, 5600004

Other trials in Japan

United Kingdom12 sites

  • Royal United Hospital

    Bath, BA1 3NG

  • Re-Cognition Health Birmingham

    Birmingham, B16 8LT

  • Re-Cognition Health Bristol

    Bristol, BS32 4SY

  • Scottish Brain Sciences

    Edinburgh, EH12 5PJ

  • Re-Cognition Health Guildford

    Guildford, GU2 7YD

  • Re-Cognition Health London

    London, W1G 8TA

  • Kings College Hospital

    London, WC2R 2LS

  • University of Oxford

    Oxford, OX3 7JX

  • Re-Cognition Health Plymouth

    Plymouth, PL6 8BT

  • Moorgreen Hospital Memory Assessment And Research Centre

    Southampton, S03 3JB

  • Southampton General Hospital

    Southampton, SO16 6YD

  • Re-Cognition Health Winchester

    Winchester, SO23 8SR

Other trials in United Kingdom

Spain11 sites

  • Barcelona Beta Brain Research Center

    Barcelona, 08005

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

    Barcelona, 08028

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Centro At. Esp. Oroitu

    Getxo, 48993

  • Hosp. Univ. Santa Maria

    Lleida, 25198

  • Hosp. Clinico San Carlos

    Madrid, 28040

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223

  • Idc Salud Hosp. Gral. de Catalunya

    Sant Cugat del Vallès, 08195

  • Hosp. Mutua Terrassa

    Terrassa, 08222

  • Hosp. Viamed Montecanal

    Zaragoza, 50012

Other trials in Spain

Australia7 sites

  • Neuro Trials Victoria

    Carlton, 3053

  • The Prince Charles Hospital

    Chermside, 4032

  • St Vincent's Centre for Applied Medical Research

    Darlinghurst, 2010

  • Austin Health Heidelberg Repatriation Hospital

    Ivanhoe, 3079

  • Southern Neurology

    Kogarah, 2217

  • KaRa Institute of Neurological Diseases

    Macquarie Park, 2113

  • Alzheimers Research Australia

    Nedlands, 6009

Other trials in Australia

France6 sites

  • Hopital Roger Salengro - CHU Lille

    Lille, 59037

  • Hopital Nord Laennec CHU NANTES

    Nantes, 44800

  • Hopital Lariboisiere-Fernand Widal

    Paris, 75010

  • CHU Pitie Salpetriere

    Paris, 75013

  • CHU Toulouse - Hôpital La Grave

    Toulouse, 31059

  • CHRU Tours Hopital Bretonneau

    Tours, 37000

Other trials in France

Germany4 sites

  • Universitaetsklinikum der RWTH Aachen

    Aachen, 52074

  • Universitaetsklinikum Koeln

    Cologne, 50937

  • Universitaetsklinikum des Saarlandes

    Homburg, 66421

  • Universitatsklinikum Munster

    Münster, 48149

Other trials in Germany

Sweden2 sites

  • Skanes universitetssjukhus

    Malmö, 20502

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm, 14186

Other trials in Sweden

Belgium1 site

  • Az Groeninge

    Kortrijk, 8500

Other trials in Belgium

About this study

Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study, to Assess Efficacy, Safety and Immunogenicity of JNJ-64042056, a Phosphorylated Tau Targeted Active Immunotherapy, in Participants With Preclinical Alzheimer's Disease

The purpose of this study is to assess whether JNJ-64042056 affects the spread and build up of tau (a protein in brain) when compared with placebo, using brain scan (tau PET) to determine results from specific areas of the brain.

Being tested
JNJ-64042056, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-64042056Drug

    JNJ-64042056 will be administered intramuscularly.

  • PlaceboDrug

    Placebo will be administered intramuscularly.

Study groups in NCT06544616
Study groupRoleWhat they receive
Arm A: JNJ-64042056ExperimentalParticipants will receive intramuscular (IM) injection of JNJ-64042056 from Week 0 up to a maximum of Week 76.
Receives: Drug: JNJ-64042056
Arm B: PlaceboPlacebo comparatorParticipants will receive IM injection of placebo from Week 0 up to a maximum of Week 76.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Brain Tau Burden as Measured by Tau PET in Specified Regions of Interest (ROI)

    Change from baseline in brain tau burden, as measured by tau PET (including but not limited to Braak I-VI ROIs, tau naive composite ROI, Connection Rank ROI, and New Tau Composite ROI Volume) will be reported.

    Measured: Baseline up to Week 102

Secondary outcomes (8)

  1. Levels of IgG Titers Against Enriched Paired Helical Filaments (ePHF), p-tau and tau in Serum

    Levels of IgG titers against ePHF, p-tau peptide and tau peptide in serum will be measured.

    Measured: Up to Week 102

  2. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical or biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

    Measured: Up to Week 104

  3. Number of Participants With Reactogenicity

    Solicited AEs will be used to assess the reactogenicity of the active immunotherapy and are predefined local (at the injection site) and systemic events for which the participant is specifically questioned, and which are noted by participants in their participant diary.

    Measured: Up to Week 78

  4. Number of Participants with Vital Signs Abnormalities

    Participants with vital signs abnormalities including temperature and blood pressure (systolic and diastolic) (supine) will be summarized over time.

    Measured: Up to Week 102

  5. Number of Participants with Clinical Laboratory Abnormalities

    Participants with clinical laboratory abnormalities values (chemistry, hematology, urinalysis and coagulation) will be reported.

    Measured: Up to Week 102

  6. Change from Baseline in Electrocardiogram (ECG) Values

    Change from baseline in ECG values will be reported.

    Measured: Baseline up to Week 102

  7. Change From Baseline in Columbia-Suicidality Severity Rating Scale (C-SSRS)

    A frequency distribution of C-SSRS scores at each scheduled time point by treatment will be provided. Shifts from the baseline visit to the most severe/maximum score during the treatment period will be summarized by treatment. The maximum score assigned for each participant will also be summarized into 1 of 3 categories: no suicidal ideation or behavior (0), suicidal ideation (1 to 5), suicidal behavior (6 to 10).

    Measured: Baseline up to Week 102

  8. Change From Baseline in Magnetic Resonance Imaging (MRI) Findings

    Change from baseline in brain MRI safety findings will be reported.

    Measured: Baseline up to Week 102

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start22 Jul 2024
  3. Primary completion22 Dec 2026 (estimated)
  4. Study completion5 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06544616
Sponsor's protocol ID
64042056ALZ2001
Other IDs
2023-505096-68-00, 2023
Acronym
Reτain
Status last verified
Nov 2026
First submitted
6 Aug 2024
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.jnj.com/innovativemedicine/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-64042056 in people with Alzheimer Disease, run by Janssen Pharmaceutica N.V., Belgium at 90 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, Japan, United Kingdom, Spain, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Brain Tau Burden as Measured by Tau PET in Specified Regions of Interest (ROI) (time frame: Baseline up to Week 102). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06544616.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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