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A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease (Autonomy)

Primary Purpose

Alzheimer Disease, Cognitive Dysfunction, Dementia

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JNJ-63733657
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Alabama BirminghamRecruiting
  • Dignity HealthRecruiting
  • Irvine Clinical ResearchRecruiting
  • University of California San Diego Medical CenterRecruiting
  • University of California - Los AngelesRecruiting
  • Stanford University Medical CenterRecruiting
  • Pacific Research Network PrnRecruiting
  • Syrentis Clinical ResearchRecruiting
  • Yale University School Of MedicineRecruiting
  • Georgetown University HospitalRecruiting
  • JEM Research, LLCRecruiting
  • Brain Matters ResearchRecruiting
  • Neuropsychiatric Research Center of SWFLRecruiting
  • Clinical NeuroScience Solutions, IncRecruiting
  • Alphab Global ResearchRecruiting
  • ClinCloud Clinical ResearchRecruiting
  • Merritt Island Medical Research, LLCRecruiting
  • University of Miami Miller School of MedicineRecruiting
  • Miami Jewish Health SystemRecruiting
  • Collier Neurologic Specialists LLCRecruiting
  • Renstar Medical ResearchRecruiting
  • Sensible HealthcareRecruiting
  • K2 Medical ResearchRecruiting
  • Axiom Clinical Research of Florida
  • Stedman Clinical Trials
  • University of South Florida - Health Byrd Alzheimer InstituteRecruiting
  • Charter ResearchRecruiting
  • ClinCloud Clinical ResearchRecruiting
  • Alzheimers Research and Treatment CenterRecruiting
  • Palm Beach Neurology and Premier Research InstituteRecruiting
  • Conquest ResearchRecruiting
  • Emory ClinicRecruiting
  • Sandhill Research
  • Great Lakes Clinical TrialsRecruiting
  • Alexian Brothers Medical Center - Neuroscience Research InstituteRecruiting
  • Indiana UniversityRecruiting
  • Massachusetts General HospitalRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Anil Nair dba Alzheimer's Disease CenterRecruiting
  • Hattiesburg ClinicRecruiting
  • Washington University School of MedicineRecruiting
  • NeuroCognitive Institute
  • Princeton Medical InstituteRecruiting
  • Advanced Memory Research Institute of NJRecruiting
  • Neurological Associates of Albany, PCRecruiting
  • Velocity Clinical ResearchRecruiting
  • New York University Medical CenterRecruiting
  • Wake Forest Health SciencesRecruiting
  • Cleveland Clinic Lou Revo Center for Brain HealthRecruiting
  • Wexner Medical Center at the Ohio State UniversityRecruiting
  • Keystone Clinical Studies, LLCRecruiting
  • Brown University School of MedicineRecruiting
  • The University of Texas Health Science Center at HoustonRecruiting
  • Memory Clinic IncRecruiting
  • University of VirginiaRecruiting
  • Royal Adelaide HospitalRecruiting
  • Box Hill HospitalRecruiting
  • Neuro Trials VictoriaRecruiting
  • Austin HealthRecruiting
  • HammondCare Neurodegenerative Clinical Trials - VICRecruiting
  • Australian Alzheimer's Research Foundation IncorporatedRecruiting
  • Royal Melbourne HospitalRecruiting
  • AZ St.-Jan Brugge-Oostende AV
  • UCL Hopital Saint-Luc
  • UZ Antwerpen
  • Universitair Ziekenhuis Gent
  • Jessa Ziekenhuis
  • UZ Brussel
  • UZ Leuven
  • Algemeen Ziekenhuis Delta
  • Parkwood InstituteRecruiting
  • Kawartha Centre - Redefining Healthy AgingRecruiting
  • UHN-Toronto Western HospitalRecruiting
  • McGill UniversityRecruiting
  • Toronto Memory Program (Neurology Research Inc.)Recruiting
  • Hopital Pellegrin CHU BordeauxRecruiting
  • Hopital Roger Salengro - CHU LilleRecruiting
  • CHU Nantes - Hopital Nord LaënnecRecruiting
  • Hopital Lariboisiere-Fernand WidalRecruiting
  • Hopital Pitie SalpetriereRecruiting
  • Chu Rennes - Hopital PontchaillouRecruiting
  • Hopital Charles NicolleRecruiting
  • CHU Toulouse - Hôpital La GraveRecruiting
  • Hôpital BretonneauRecruiting
  • Takeda General Hospital
  • Inage Neurology and Memory Clinic
  • Kawashima Neurology Clinic
  • Fukuoka University Hospital
  • Keikokai P-One Clinic
  • Himeji Central Hospital Clinic
  • Shonan Kamakura General Hospital
  • National Hospital Organization Hizen Psychiatric Center
  • Koukankai Koukan Clinic
  • Kobe City Medical Center General Hospital
  • Rijikai Medical Corporation Katayama Medical Clinic
  • Kurume University Hospital
  • Rakuwakai Otowa Rehabilitation Hospital
  • Rakuwakai Otowa Hospital
  • Saiseikai Narashino Hospital
  • National Center For Geriatrics And Gerontology
  • Clinical Research Hospital Tokyo
  • Tokyo Medical University Hospital
  • Tokyo Metropolitan Geriatric Hospital
  • Jinsenkai MI Clinic
  • Nagomi Clinic
  • Yokohama Brain and Spine Center
  • BRC - AmsterdamRecruiting
  • BRC - Den BoschRecruiting
  • QPS NetherlandsRecruiting
  • BRC - ZwolleRecruiting
  • Centro At. Esp. OroituRecruiting
  • Hosp. Del MarRecruiting
  • Hosp. de La Santa Creu I Sant PauRecruiting
  • Fund. Ace-Inst. Cat. Neuroc. AplicadesRecruiting
  • Idc Salud Hosp. Gral. de CatalunyaRecruiting
  • Hosp. Univ. Santa MariaRecruiting
  • Hosp. Clinico San CarlosRecruiting
  • Hosp. Mutua TerrassaRecruiting
  • Hosp. Univ. I Politecni La FeRecruiting
  • Karolinska UniversitetssjukhusetRecruiting
  • Royal United HospitalRecruiting
  • Charing Cross HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

JNJ-63733657

Placebo

Arm Description

Participants will receive single dose of JNJ-63733657 low dose or high dose administered by intravenous (IV) infusion every 4 weeks.

Participants will receive single dose of matching placebo to JNJ-63733657 administered by IV infusion every 4 weeks.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive subscale 13-item version (ADAS-Cog 13) Total Score at Week 104
ADAS-Cog11 consists of 11 tasks measuring the disturbances of memory, language, praxis, attention, and other cognitive abilities. The modified ADAS-Cog 13 item scale includes all original ADAS-Cog items with the addition of a number cancellation task and a delayed free recall task, for a maximum total score of 85 points, with higher scores indicative of worse cognitive performance. Thus, a negative change from baseline represents improvement in cognition. Items are recorded on an electronic device which will provide the ADAS-Cog 13 total score.
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
ADCS-ADL MCI is a functional measure based on information provided by the study partner (informant) that describes the performance of participants in several ADLs. It assesses 18 instrumental activities of daily living (higher level daily functions) and one basic daily function (dressing). Total score ranges from 0 to 53 with higher scores indicating less impairment.
Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index Score
The RBANS includes 12 subtests that are divided into 5 RBANS indices: 1-Immediate memory (List learning and story memory); 2-Visuospatial/constructional (figure copy and line orientation); 3-Language (picture naming and semantic fluency); 4-Attention (digit span and coding); 5-Delayed memory (list recall, list recognition, story memory, and figure recall) will be reported. Index scores are expressed as an age-adjusted standard score with a normal mean of 100 and an SD of 15. The sum of Index Scores is the sum of the 5 index scores, and the Sum of Index Scores is converted to an RBANS Total Scale Index Score via a mapping table. RBANS Total Scale Index Score is a norm-based t-score, based on a distribution with a mean of 100 and standard deviation (SD) of 15. Higher scores on each sub measure and index indicate better performance.
Change From Baseline in RBANS Indices
Change from baseline in RBANS indices will be assessed. The RBANS includes 12 subtests that are divided into 5 RBANS indices: 1-Immediate memory (List learning and story memory); 2-Visuospatial/constructional (figure copy and line orientation); 3-Language (picture naming and semantic fluency); 4-Attention (digit span and coding); 5-Delayed memory (list recall, list recognition, story memory, and figure recall) will be reported.
Change From Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB)
CDR is a global clinical staging instrument that includes 3 cognitive and 3 functional ratings, including: memory, orientation, judgment and problem solving, involvement in community affairs, home and hobbies, and personal care based on the CDR interview. The CDR is scored 2 ways yielding a global CDR score (CDR GS, derived from an algorithm including categorical scoring of 0, 0.5, 1, 2, and 3), as well as CDR-Sum of Boxes (CDR-SB, the continuous sum of 6 domains, up to a total score of 18, with higher scores representing worse disease state). The Sum of boxes and global score is calculated from the overall CDR.
Change from Baseline in Neuropsychiatric Inventory (NPI)
The NPI is a measure of psychobehavioral disturbances, assessing the frequency and severity of disturbances in 12 domains. Frequency for each domain is rated on a 4 point scale (from 1=rarely to 4=very often) and severity on a 3 point scale (from 1=mild to 3=severe), with the score for each domain being the product of the frequency and severity scores, such that each domain is scored from 1 to 12. The NPI total score is the sum of the 12 domain scores, ranging from 0 (best) to 144 (worst).
Percentage of Participants Progressing From Clinical Dementia Rating- Global Score (CDR-GS) 0 to 0.5 or Higher, 0.5 to 1 or Higher, 1 to 2 or Higher, from Baseline to Post-baseline
The CDR is a subjectively rated outcome measure that serves as a global clinical staging instrument that includes 3 cognitive and 3 functional ratings, including: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the CDR interview. The CDR is scored 2 ways yielding a global CDR score (CDR GS, derived from an algorithm developed by the Knight Alzheimer Disease Research Center at Washington University School of Medicine in St. Louis, Missouri, US, and including categorical scoring of 0= cognitively unimpaired, 0.5= mild cognitive impairment, 1= mild dementia, 2= moderate dementia, and 3= severe dementia), as well as CDR-Sum of Boxes (CDR-SB, the continuous sum of 6 domains, up to a total score of 18, with higher scores representing worse disease state).
Change From Baseline in Brain tau Burden as Measured by tau PET
Change from baseline in brain tau burden, as measured by tau positron emission tomography (PET) will be assessed.
Change From Baseline in Cerebrospinal Fluid (CSF) concentrations of Total, Free, and Bound p217+tau Fragments
Change from baseline in CSF concentrations of total, free, and bound p217+tau (phosphorylated tau) fragments will be assessed.
CSF Concentrations of JNJ-63733657
CSF concentrations of JNJ-63733657 will be assessed.
Serum Concentrations of JNJ-63733657
Serum concentrations of JNJ-63733657 will be assessed.
Anti-Drug Antibody to JNJ-63733657
Anti-drug antibody to JNJ-63733657 will be assessed.
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Number of Participants with Electrocardiogram (ECG) Abnormalities
Number of participants with ECG abnormalities will be reported.
Number of Participants with Clinical Laboratory Abnormalities
Number of participants with clinical laboratory (hematology, clinical chemistry, and urinalysis) abnormalities will be assessed.
Number of Participants with Physical and Neurological Examination Abnormalities
Number of participants with physical (body weight, height) and neurological (evaluation of mental status, cranial nerves, motor ability [including strength, tone, and involuntary movements], coordination [including finger-to-nose, gait, and postural reflexes], and sensation [including proprioception, cold, light touch, and deep tendon reflexes]) examination abnormalities will be reported.
Percentage of Participants with Vital Sign Abnormalities
Percentage of participants with vital sign abnormalities (temperature, pulse rate, systolic blood pressure [BP], diastolic BP) will be reported.
Changes From Baseline in Brain Magnetic Resonance Imaging (MRI) Safety Findings
Changes from baseline in brain MRI safety findings (brain tumors, aneurysm or atrioventricular malformations, territorial stroke (excluding smaller watershed strokes), recent hemorrhage (parenchymal or subdural), or obstructive hydrocephalus) will be assessed.
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) score
C-SSRS is semi structured clinician-administered questionnaire designed to solicit the occurrence, severity, and frequency of suicide-related ideation and behaviors . Total score ranges from 1 to 10, a score of 0 will be assigned (0="no event that can be assessed on the basis of C-SSRS"). Higher scores indicate greater severity. The maximum score assigned for each participant will also be summarized into one of three broad categories: no suicidal ideation or behavior (0), suicidal ideation (1 to 5), suicidal behavior (6 to 10).

Full Information

First Posted
November 5, 2020
Last Updated
August 15, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04619420
Brief Title
A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease
Acronym
Autonomy
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants With Early Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2021 (Actual)
Primary Completion Date
March 7, 2025 (Anticipated)
Study Completion Date
November 5, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Alzheimer's disease (AD) is a fatal neurodegenerative disease that is manifested by progressive cognitive deficits including memory loss followed by loss of independent function as well as neuropsychiatric symptoms such as apathy, depression, anxiety, agitation and psychosis. JNJ-63733657 is a humanized monoclonal anti-tau antibody which binds to phosphorylated tau (P-tau). The study will evaluate whether JNJ-63733657 can slow clinical (cognitive and functional) decline in participants with Early AD with evidence of elevated brain tau (T+) and assess its safety and tolerability. The study consists of: screening period (13 weeks), double-blind treatment period (up to 232 weeks), and a follow-up period (13 weeks). Safety and tolerability assessments will include adverse events (AEs), vital signs, electrocardiogram (ECG), early discontinuations, physical and neurological examinations, safety laboratory evaluations, suicidality risks (Columbia Suicide Severity Rating Scale [CSSRS]) and brain MRI will be performed during the study. The maximum treatment duration is up to 232 weeks (4.5 years).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Cognitive Dysfunction, Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JNJ-63733657
Arm Type
Experimental
Arm Description
Participants will receive single dose of JNJ-63733657 low dose or high dose administered by intravenous (IV) infusion every 4 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive single dose of matching placebo to JNJ-63733657 administered by IV infusion every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
JNJ-63733657
Intervention Description
JNJ-63733657 low or high dose will be administered by IV infusion.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to JNJ-63733657 will be administered by IV infusion.
Primary Outcome Measure Information:
Title
Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Total Score at Week 104
Description
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).
Time Frame
Week 104
Secondary Outcome Measure Information:
Title
Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive subscale 13-item version (ADAS-Cog 13) Total Score at Week 104
Description
ADAS-Cog11 consists of 11 tasks measuring the disturbances of memory, language, praxis, attention, and other cognitive abilities. The modified ADAS-Cog 13 item scale includes all original ADAS-Cog items with the addition of a number cancellation task and a delayed free recall task, for a maximum total score of 85 points, with higher scores indicative of worse cognitive performance. Thus, a negative change from baseline represents improvement in cognition. Items are recorded on an electronic device which will provide the ADAS-Cog 13 total score.
Time Frame
Week 104
Title
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
Description
ADCS-ADL MCI is a functional measure based on information provided by the study partner (informant) that describes the performance of participants in several ADLs. It assesses 18 instrumental activities of daily living (higher level daily functions) and one basic daily function (dressing). Total score ranges from 0 to 53 with higher scores indicating less impairment.
Time Frame
Week 104
Title
Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index Score
Description
The RBANS includes 12 subtests that are divided into 5 RBANS indices: 1-Immediate memory (List learning and story memory); 2-Visuospatial/constructional (figure copy and line orientation); 3-Language (picture naming and semantic fluency); 4-Attention (digit span and coding); 5-Delayed memory (list recall, list recognition, story memory, and figure recall) will be reported. Index scores are expressed as an age-adjusted standard score with a normal mean of 100 and an SD of 15. The sum of Index Scores is the sum of the 5 index scores, and the Sum of Index Scores is converted to an RBANS Total Scale Index Score via a mapping table. RBANS Total Scale Index Score is a norm-based t-score, based on a distribution with a mean of 100 and standard deviation (SD) of 15. Higher scores on each sub measure and index indicate better performance.
Time Frame
Baseline and up to 4.5 years (End of treatment)
Title
Change From Baseline in RBANS Indices
Description
Change from baseline in RBANS indices will be assessed. The RBANS includes 12 subtests that are divided into 5 RBANS indices: 1-Immediate memory (List learning and story memory); 2-Visuospatial/constructional (figure copy and line orientation); 3-Language (picture naming and semantic fluency); 4-Attention (digit span and coding); 5-Delayed memory (list recall, list recognition, story memory, and figure recall) will be reported.
Time Frame
Baseline and up to 4.5 years (End of treatment)
Title
Change From Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB)
Description
CDR is a global clinical staging instrument that includes 3 cognitive and 3 functional ratings, including: memory, orientation, judgment and problem solving, involvement in community affairs, home and hobbies, and personal care based on the CDR interview. The CDR is scored 2 ways yielding a global CDR score (CDR GS, derived from an algorithm including categorical scoring of 0, 0.5, 1, 2, and 3), as well as CDR-Sum of Boxes (CDR-SB, the continuous sum of 6 domains, up to a total score of 18, with higher scores representing worse disease state). The Sum of boxes and global score is calculated from the overall CDR.
Time Frame
Baseline and up to 4.5 years (End of treatment)
Title
Change from Baseline in Neuropsychiatric Inventory (NPI)
Description
The NPI is a measure of psychobehavioral disturbances, assessing the frequency and severity of disturbances in 12 domains. Frequency for each domain is rated on a 4 point scale (from 1=rarely to 4=very often) and severity on a 3 point scale (from 1=mild to 3=severe), with the score for each domain being the product of the frequency and severity scores, such that each domain is scored from 1 to 12. The NPI total score is the sum of the 12 domain scores, ranging from 0 (best) to 144 (worst).
Time Frame
Baseline and up to 4.5 years (End of treatment)
Title
Percentage of Participants Progressing From Clinical Dementia Rating- Global Score (CDR-GS) 0 to 0.5 or Higher, 0.5 to 1 or Higher, 1 to 2 or Higher, from Baseline to Post-baseline
Description
The CDR is a subjectively rated outcome measure that serves as a global clinical staging instrument that includes 3 cognitive and 3 functional ratings, including: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the CDR interview. The CDR is scored 2 ways yielding a global CDR score (CDR GS, derived from an algorithm developed by the Knight Alzheimer Disease Research Center at Washington University School of Medicine in St. Louis, Missouri, US, and including categorical scoring of 0= cognitively unimpaired, 0.5= mild cognitive impairment, 1= mild dementia, 2= moderate dementia, and 3= severe dementia), as well as CDR-Sum of Boxes (CDR-SB, the continuous sum of 6 domains, up to a total score of 18, with higher scores representing worse disease state).
Time Frame
Baseline and up to 4.5 years (End of treatment)
Title
Change From Baseline in Brain tau Burden as Measured by tau PET
Description
Change from baseline in brain tau burden, as measured by tau positron emission tomography (PET) will be assessed.
Time Frame
Baseline and up to 4.5 years (End of treatment)
Title
Change From Baseline in Cerebrospinal Fluid (CSF) concentrations of Total, Free, and Bound p217+tau Fragments
Description
Change from baseline in CSF concentrations of total, free, and bound p217+tau (phosphorylated tau) fragments will be assessed.
Time Frame
Baseline and up to 4.5 years (End of treatment)
Title
CSF Concentrations of JNJ-63733657
Description
CSF concentrations of JNJ-63733657 will be assessed.
Time Frame
At Weeks 52, 104, 208 (End of Treatment)
Title
Serum Concentrations of JNJ-63733657
Description
Serum concentrations of JNJ-63733657 will be assessed.
Time Frame
At Weeks 4, 8, 12, 16, 20, 24, 36, 52, 76, 104, 128, 156, 180, 208, 232 (End of treatment)
Title
Anti-Drug Antibody to JNJ-63733657
Description
Anti-drug antibody to JNJ-63733657 will be assessed.
Time Frame
Up to 245 Weeks (90 days [+-7 days] after last dose of study intervention)
Title
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Description
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
Time Frame
Up to 245 Weeks
Title
Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Description
An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time Frame
Up to 245 Weeks
Title
Number of Participants with Electrocardiogram (ECG) Abnormalities
Description
Number of participants with ECG abnormalities will be reported.
Time Frame
Up to 245 Weeks
Title
Number of Participants with Clinical Laboratory Abnormalities
Description
Number of participants with clinical laboratory (hematology, clinical chemistry, and urinalysis) abnormalities will be assessed.
Time Frame
Baseline and up to 245 Weeks
Title
Number of Participants with Physical and Neurological Examination Abnormalities
Description
Number of participants with physical (body weight, height) and neurological (evaluation of mental status, cranial nerves, motor ability [including strength, tone, and involuntary movements], coordination [including finger-to-nose, gait, and postural reflexes], and sensation [including proprioception, cold, light touch, and deep tendon reflexes]) examination abnormalities will be reported.
Time Frame
Up to 245 Weeks
Title
Percentage of Participants with Vital Sign Abnormalities
Description
Percentage of participants with vital sign abnormalities (temperature, pulse rate, systolic blood pressure [BP], diastolic BP) will be reported.
Time Frame
Up to 245 Weeks
Title
Changes From Baseline in Brain Magnetic Resonance Imaging (MRI) Safety Findings
Description
Changes from baseline in brain MRI safety findings (brain tumors, aneurysm or atrioventricular malformations, territorial stroke (excluding smaller watershed strokes), recent hemorrhage (parenchymal or subdural), or obstructive hydrocephalus) will be assessed.
Time Frame
Baseline and Up to 4.5 years (End of treatment)
Title
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) score
Description
C-SSRS is semi structured clinician-administered questionnaire designed to solicit the occurrence, severity, and frequency of suicide-related ideation and behaviors . Total score ranges from 1 to 10, a score of 0 will be assigned (0="no event that can be assessed on the basis of C-SSRS"). Higher scores indicate greater severity. The maximum score assigned for each participant will also be summarized into one of three broad categories: no suicidal ideation or behavior (0), suicidal ideation (1 to 5), suicidal behavior (6 to 10).
Time Frame
Baseline and Up to 245 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
Dignity Health
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Name
Irvine Clinical Research
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Name
Pacific Research Network Prn
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Name
Syrentis Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Individual Site Status
Recruiting
Facility Name
JEM Research, LLC
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Individual Site Status
Recruiting
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Individual Site Status
Recruiting
Facility Name
Neuropsychiatric Research Center of SWFL
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical NeuroScience Solutions, Inc
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Name
Alphab Global Research
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Individual Site Status
Recruiting
Facility Name
ClinCloud Clinical Research
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Name
Merritt Island Medical Research, LLC
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32952
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
Miami Jewish Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Individual Site Status
Recruiting
Facility Name
Collier Neurologic Specialists LLC
City
Naples
State/Province
Florida
ZIP/Postal Code
34105
Country
United States
Individual Site Status
Recruiting
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Individual Site Status
Recruiting
Facility Name
Sensible Healthcare
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Individual Site Status
Recruiting
Facility Name
K2 Medical Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Completed
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Completed
Facility Name
University of South Florida - Health Byrd Alzheimer Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
Charter Research
City
The Villages
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Individual Site Status
Recruiting
Facility Name
ClinCloud Clinical Research
City
Viera
State/Province
Florida
ZIP/Postal Code
32904
Country
United States
Individual Site Status
Recruiting
Facility Name
Alzheimers Research and Treatment Center
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Individual Site Status
Recruiting
Facility Name
Palm Beach Neurology and Premier Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Recruiting
Facility Name
Conquest Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Name
Sandhill Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Completed
Facility Name
Great Lakes Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Individual Site Status
Recruiting
Facility Name
Alexian Brothers Medical Center - Neuroscience Research Institute
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Anil Nair dba Alzheimer's Disease Center
City
Braintree
State/Province
Massachusetts
ZIP/Postal Code
02184
Country
United States
Individual Site Status
Recruiting
Facility Name
Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
NeuroCognitive Institute
City
Mount Arlington
State/Province
New Jersey
ZIP/Postal Code
07856
Country
United States
Individual Site Status
Completed
Facility Name
Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Memory Research Institute of NJ
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurological Associates of Albany, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Individual Site Status
Recruiting
Facility Name
New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic Lou Revo Center for Brain Health
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
Wexner Medical Center at the Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Individual Site Status
Recruiting
Facility Name
Keystone Clinical Studies, LLC
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Individual Site Status
Recruiting
Facility Name
Brown University School of Medicine
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Name
Memory Clinic Inc
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Box Hill Hospital
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Recruiting
Facility Name
Neuro Trials Victoria
City
Carlton
ZIP/Postal Code
3053
Country
Australia
Individual Site Status
Recruiting
Facility Name
Austin Health
City
Ivanhoe
ZIP/Postal Code
3079
Country
Australia
Individual Site Status
Recruiting
Facility Name
HammondCare Neurodegenerative Clinical Trials - VIC
City
Malvern
ZIP/Postal Code
3144
Country
Australia
Individual Site Status
Recruiting
Facility Name
Australian Alzheimer's Research Foundation Incorporated
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Melbourne Hospital
City
Parkville
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Recruiting
Facility Name
AZ St.-Jan Brugge-Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
UCL Hopital Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
UZ Brussel
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Algemeen Ziekenhuis Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Parkwood Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N65J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Kawartha Centre - Redefining Healthy Aging
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9H 2P4
Country
Canada
Individual Site Status
Recruiting
Facility Name
UHN-Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Toronto Memory Program (Neurology Research Inc.)
City
Toronto
ZIP/Postal Code
M3B 257
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hopital Pellegrin CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Roger Salengro - CHU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Nantes - Hopital Nord Laënnec
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Lariboisiere-Fernand Widal
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
Chu Rennes - Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35009
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Toulouse - Hôpital La Grave
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Recruiting
Facility Name
Takeda General Hospital
City
Aizuwakamatsu
ZIP/Postal Code
965-8585
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Inage Neurology and Memory Clinic
City
Chiba-shi
ZIP/Postal Code
263-0043
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kawashima Neurology Clinic
City
Fujisawa-shi
ZIP/Postal Code
251-0038
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Keikokai P-One Clinic
City
Hachioji
ZIP/Postal Code
192-0071
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Himeji Central Hospital Clinic
City
Himeji-city, Hyogo
ZIP/Postal Code
672-8043
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Shonan Kamakura General Hospital
City
Kamakura-shi
ZIP/Postal Code
247-8533
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
National Hospital Organization Hizen Psychiatric Center
City
Kanzaki-gun
ZIP/Postal Code
842-0192
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Koukankai Koukan Clinic
City
Kawasaki-shi
ZIP/Postal Code
210-0852
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kobe City Medical Center General Hospital
City
Kobe-shi
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Completed
Facility Name
Rijikai Medical Corporation Katayama Medical Clinic
City
Kurashiki-shi
ZIP/Postal Code
7100813
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kurume University Hospital
City
Kurume
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Rakuwakai Otowa Rehabilitation Hospital
City
Kyoto-shi
ZIP/Postal Code
607-8113
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Rakuwakai Otowa Hospital
City
Kyoto
ZIP/Postal Code
607-8062
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Saiseikai Narashino Hospital
City
Narashino
ZIP/Postal Code
275-0006
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
National Center For Geriatrics And Gerontology
City
Obu-shi
ZIP/Postal Code
474-8511
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Hospital Tokyo
City
Shinjuku-ku
ZIP/Postal Code
162-0053
Country
Japan
Individual Site Status
Completed
Facility Name
Tokyo Medical University Hospital
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tokyo Metropolitan Geriatric Hospital
City
Tokyo
ZIP/Postal Code
173-0015
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Jinsenkai MI Clinic
City
Toyonaka-shi
ZIP/Postal Code
560-0004
Country
Japan
Individual Site Status
Completed
Facility Name
Nagomi Clinic
City
Toyonaka-shi
ZIP/Postal Code
560-0004
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Yokohama Brain and Spine Center
City
Yokohama-shi
ZIP/Postal Code
235-0012
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
BRC - Amsterdam
City
Amsterdam
ZIP/Postal Code
1081 GN
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
BRC - Den Bosch
City
Den Bosch
ZIP/Postal Code
5223 LA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
QPS Netherlands
City
Leeuwarden
ZIP/Postal Code
8934AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
BRC - Zwolle
City
Zwolle
ZIP/Postal Code
8052 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Centro At. Esp. Oroitu
City
Algorta - Getxo
ZIP/Postal Code
48993
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Fund. Ace-Inst. Cat. Neuroc. Aplicades
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Individual Site Status
Recruiting
Facility Name
Idc Salud Hosp. Gral. de Catalunya
City
Barcelona
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Santa Maria
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Mutua Terrassa
City
Terrassa
ZIP/Postal Code
08221
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. I Politecni La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Karolinska Universitetssjukhuset
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Royal United Hospital
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease

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