A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease
Autonomy
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study With a Long-Term Extension Treatment Period to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants With Early Alzheimer's Disease
4 other identifiers
interventional
523
10 countries
122
Brief Summary
The primary purpose of this study is to evaluate the effect of JNJ-63733657 versus placebo on clinical decline as measured by the Integrated Alzheimer's Disease Rating Scale (iADRS), a composite of cognition and function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 alzheimer-disease
Started Jan 2021
Longer than P75 for phase_2 alzheimer-disease
122 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2020
CompletedFirst Posted
Study publicly available on registry
November 6, 2020
CompletedStudy Start
First participant enrolled
January 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2026
CompletedFebruary 13, 2026
February 1, 2026
4.8 years
November 5, 2020
February 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Total Score at Week 104
The linear combination of the ADAS Cog13 and ADCS ADL MCI that serves as a composite of cognition and function (overall clinical status) of the participant and score range from 0 to 138 with lower scores indicating worse performance. The iADRS will be a combination of ADAS Cog13 (score 0 to 85, higher scores indicate worse cognitive performance) and ADCS-ADL MCI (yielding a score 0 to 53, lower scores indicate worse daily function).
Week 104
Secondary Outcomes (21)
Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive subscale 13-item version (ADAS-Cog 13) Total Score at Week 104
Week 104
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living for Mild Cognitive Impairment (ADCS-ADL MCI) Total Score at Week 104
Week 104
Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index Score at Week 88
Baseline, Week 88
Change From Baseline in RBANS Indices at Week 88
Baseline, Week 88
Change From Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) at Week 104
Baseline, Week 104
- +16 more secondary outcomes
Study Arms (3)
JNJ-63733657 Low-dose
EXPERIMENTALParticipants will receive single dose of JNJ-63733657 low-dose administered by intravenous (IV) infusion every 4 weeks during the double-blind treatment period. Participants will have an option to continue with the long-term extension (LTE) phase of the trial and will continue to receive the same treatment and dose during the LTE treatment period.
JNJ-63733657 High-dose
EXPERIMENTALParticipants will receive single dose of JNJ-63733657 high-dose administered by IV infusion every 4 weeks during double-blind treatment period. Participants will have an option to continue with the LTE phase of the trial and will continue to receive the same treatment and dose during the LTE treatment period.
Placebo
PLACEBO COMPARATORParticipants will receive single dose of matching placebo to JNJ-63733657 administered by IV infusion every 4 weeks during double-blind treatment period. Participants will have an option to continue with the LTE phase of the trial and will be re-randomized in a 1:1 ratio to receive either JNJ-63733657 low-dose or JNJ-63733657 high-dose during the LTE treatment period.
Interventions
JNJ-63733657 low or high dose will be administered by IV infusion.
Eligibility Criteria
You may qualify if:
- Early Alzheimer's disease (AD): Gradual and progressive subjective decline in the participant's cognition over at least the past 6 months, as reported by the participant and informant (study partner) and Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 and memory box score greater than or equal to (\>=) 0.5 at screening
- Participants must have positive tau PET results
- Able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening
- Have a designated study partner who has adequate literacy to participate and be judged to have high likelihood of completing the study with the participant
- Male participants must agree not to donate sperm for the purpose of reproduction during the study and up to 16 weeks after receiving the last dose of study intervention
You may not qualify if:
- Participants with CDR GS \>=2 at predose baseline Clinical Dementia Rating (CDR) administration
- Participants who fulfill diagnostic criteria for Mild Cognitive Impairment (MCI) or dementia/mild or major neurocognitive disorder suspected to be due to any etiology other than AD (example, Parkinson's disease, cerebrovascular disease, normal pressure hydrocephalus, head injury, drug or alcohol abuse/dependence, anoxic brain injury, (Et cetera\[etc\])
- Geriatric Depression Scale (GDS) 30 score greater than (\>) 12
- Hachinski Ischemic Scale (HIS) \>4
- Has received medications that affect the central nervous system (CNS), except treatments for AD, for less than 2 months; that is, doses of chronic medications that effect the CNS should be stable for at least 2 months before the start of screening. If a participant has recently stopped a chronic medication that effects the CNS, he or she must have discontinued treatment at least 2 months before the start of screening. Chronic use of benzodiazepines is not permitted
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (122)
University of Alabama Birmingham
Birmingham, Alabama, 35233, United States
Dignity Health
Phoenix, Arizona, 85013, United States
Irvine Clinical Research
Irvine, California, 92614, United States
University of California San Diego Medical Center
La Jolla, California, 92037, United States
University of California - Los Angeles
Los Angeles, California, 90095, United States
Stanford University Medical Center
Palo Alto, California, 94304, United States
Pacific Research Network Prn
San Diego, California, 92103, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
Yale University School Of Medicine
New Haven, Connecticut, 06510, United States
Georgetown University Clinical Research Unit CRU
Washington D.C., District of Columbia, 20007, United States
JEM Research LLC
Atlantis, Florida, 33462, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Neuropsychiatric Research Center of SWFL
Fort Myers, Florida, 33912, United States
Clinical NeuroScience Solutions Inc
Jacksonville, Florida, 32256, United States
Alphab Global Research
Jupiter, Florida, 33458, United States
K2 Medical Research
Maitland, Florida, 32751, United States
Tandem Intermediate LLC
Maitland, Florida, 32751, United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, 32952, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
Miami Jewish Health System
Miami, Florida, 33137, United States
Aqualane Clinical Research
Naples, Florida, 34105, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Sensible Healthcare
Ocoee, Florida, 34761, United States
Axiom Clinical Research of Florida
Tampa, Florida, 33609, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
University of South Florida - Health Byrd Alzheimer Institute
Tampa, Florida, 33613, United States
Charter Research
The Villages, Florida, 32162, United States
ClinCloud Clinical Research
Viera, Florida, 32904, United States
Alzheimers Research and Treatment Center
Wellington, Florida, 33414, United States
Palm Beach Neurology and Premier Research Institute
West Palm Beach, Florida, 33407, United States
Conquest Research
Winter Park, Florida, 32789, United States
The Emory Clinic
Atlanta, Georgia, 30329, United States
Sandhill Research
Decatur, Georgia, 30030, United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
Alexian Brothers Medical Center - Neuroscience Research Institute
Elk Grove Village, Illinois, 60007, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Anil Nair dba Alzheimer's Disease Center
Braintree, Massachusetts, 02184, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Washington University School Of Medicine
St Louis, Missouri, 63110, United States
NeuroCognitive Institute
Mount Arlington, New Jersey, 07856, United States
Princeton Medical Institute
Princeton, New Jersey, 08540, United States
Advanced Memory Research Institute of NJ
Toms River, New Jersey, 08755, United States
Neurological Associates of Albany, PC
Albany, New York, 12208, United States
Velocity Clinical Research
East Syracuse, New York, 13057, United States
New York University Medical Center
New York, New York, 10016, United States
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic Lou Revo Center for Brain Health
Cleveland, Ohio, 44195, United States
Wexner Medical Center at the Ohio State University
Columbus, Ohio, 43221, United States
Keystone Clinical Studies LLC
Plymouth Meeting, Pennsylvania, 19462, United States
Brown University School of Medicine
Providence, Rhode Island, 02906, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77054, United States
Memory Clinic Inc
Bennington, Vermont, 05201, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Royal Adelaide Hospital
Adelaide, 5000, Australia
Box Hill Hospital
Box Hill, 3128, Australia
Neuro Trials Victoria
Carlton, 3053, Australia
Austin Health
Ivanhoe, 3079, Australia
HammondCare Neurodegenerative Clinical Trials - VIC
Malvern, 3144, Australia
Australian Alzheimer's Research Foundation Incorporated
Nedlands, 6009, Australia
Royal Melbourne Hospital
Parkville, 3050, Australia
AZ St.-Jan Brugge-Oostende AV
Bruges, 8000, Belgium
UCL Hopital Saint-Luc
Brussels, 1200, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Jessa Ziekenhuis
Hasselt, 3500, Belgium
UZ Brussel
Jette, 1090, Belgium
UZ Leuven
Leuven, 3000, Belgium
Algemeen Ziekenhuis Delta
Roeselare, 8800, Belgium
Parkwood Institute
London, Ontario, N6C 0A7, Canada
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, K9H 2P4, Canada
Toronto Memory Program (Neurology Research Inc.)
Toronto, Ontario, M3B 257, Canada
UHN-Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
McGill University
Montreal, Quebec, H3A 2B4, Canada
Hopital Pellegrin CHU Bordeaux
Bordeaux, 33076, France
Hopital Roger Salengro - CHU Lille
Lille, 59037, France
CHU Nantes - Hopital Nord Laënnec
Nantes, 44093, France
Hopital Lariboisiere-Fernand Widal
Paris, 75010, France
Hopital Pitie Salpetriere
Paris, 75013, France
Chu Rennes Hopital Pontchaillou
Rennes, 35009, France
Hopital Charles Nicolle
Rouen, 76031, France
CHU Toulouse - Hôpital La Grave
Toulouse, 31059, France
Hôpital Bretonneau
Tours, 37000, France
Takeda General Hospital
Aizu-Wakamatsu, 965-8585, Japan
Inage Neurology and Memory Clinic
Chiba, 263-0043, Japan
Kawashima Neurology Clinic
Fujisawa-shi, 251-0038, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Keikokai P-One Clinic
Hachiōji, 192-0071, Japan
Himeji Central Hospital Clinic
Himeji, 672-8043, Japan
Shonan Kamakura General Hospital
Kamakura-shi, 247-8533, Japan
National Hospital Organization Hizen Psychiatric Center
Kanzaki-gun, 842-0192, Japan
Koukan Clinic
Kawasaki, 210-0852, Japan
Kobe City Medical Center General Hospital
Kobe, 650-0047, Japan
Rijikai Medical Corporation Katayama Medical Clinic
Kurashiki-shi, 7100813, Japan
Kurume University Hospital
Kurume, 830-0011, Japan
Rakuwakai Otowa Hospital
Kyoto, 607-8062, Japan
Rakuwakai Otowa Rehabilitation Hospital
Kyoto, 607-8113, Japan
Saiseikai Narashino Hospital
Narashino, 275-0006, Japan
National Center For Geriatrics And Gerontology
Obu-shi, 474-8511, Japan
Clinical Research Hospital Tokyo
Shinjuku-ku, 162-0053, Japan
Tokyo Medical University Hospital
Tokyo, 160-0023, Japan
Tokyo Metropolitan Geriatric Hospital
Tokyo, 173-0015, Japan
Nagomi Clinic
Toyonaka-shi, 560-0004, Japan
Jinsenkai MI Clinic
Toyonaka-shi, 5600004, Japan
Yokohama Brain and Spine Center
Yokohama, 235-0012, Japan
BRC - Den Bosch
's-Hertogenbosch, 5223 LA, Netherlands
BRC - Amsterdam
Amsterdam, 1081 GN, Netherlands
QPS Netherlands
Leeuwarden, 8934AD, Netherlands
BRC Zwolle
Zwolle, 8052 AZ, Netherlands
Centro At. Esp. Oroitu
Algorta - Getxo, 48993, Spain
Hosp. Del Mar
Barcelona, 08003, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08025, Spain
Fund. Ace-Inst. Cat. Neuroc. Aplicades
Barcelona, 08028, Spain
Idc Salud Hosp. Gral. de Catalunya
Barcelona, 08195, Spain
Hosp. Univ. Santa Maria
Lleida, 25198, Spain
Hosp. Clinico San Carlos
Madrid, 28040, Spain
Hosp. Mutua Terrassa
Terrassa, 08221, Spain
Hosp. Univ. I Politecni La Fe
Valencia, 46026, Spain
Karolinska Universitetssjukhuset
Stockholm, 14186, Sweden
Royal United Hospital
Bath, BA1 3NG, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
Related Publications (1)
Perez-Ruixo C, Li L, Galpern WR, Perez-Ruixo JJ. Mechanistic Population Pharmacokinetic-Pharmacodynamic Model of the Tau-Targeted Antibody Posdinemab in Healthy Participants and Participants with Alzheimer's Disease. Clin Pharmacol Ther. 2026 Apr;119(4):979-989. doi: 10.1002/cpt.70173. Epub 2025 Dec 22.
PMID: 41431125DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2020
First Posted
November 6, 2020
Study Start
January 6, 2021
Primary Completion
October 17, 2025
Study Completion
March 8, 2026
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/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