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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04619420
Registration number
NCT04619420
Ethics application status
Date submitted
5/11/2020
Date registered
6/11/2020
Date last updated
22/05/2024
Titles & IDs
Public title
A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease
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Scientific title
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
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Secondary ID [1]
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2020-000116-30
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Secondary ID [2]
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CR108832
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Universal Trial Number (UTN)
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Trial acronym
Autonomy
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease
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Cognitive Dysfunction
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Dementia
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Mental Health
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - JNJ-63733657
Treatment: Drugs - Placebo
Experimental: JNJ-63733657 Low-dose - Participants 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.
Experimental: JNJ-63733657 High-dose - Participants 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 Comparator: Placebo - Participants 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.
Treatment: Drugs: JNJ-63733657
JNJ-63733657 low or high dose will be administered by IV infusion.
Treatment: Drugs: Placebo
Placebo matching to JNJ-63733657 will be administered by IV infusion.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Total Score at Week 104
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Assessment method [1]
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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).
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Timepoint [1]
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Week 104
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Secondary outcome [1]
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Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive subscale 13-item version (ADAS-Cog 13) Total Score at Week 104
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Assessment method [1]
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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.
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Timepoint [1]
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Week 104
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Secondary outcome [2]
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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
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Assessment method [2]
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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.
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Timepoint [2]
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Week 104
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Secondary outcome [3]
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Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index Score at Week 88
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, Week 88
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Secondary outcome [4]
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Change From Baseline in RBANS Indices at Week 88
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, Week 88
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Secondary outcome [5]
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Change From Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) at Week 104
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline, Week 104
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Secondary outcome [6]
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Change from Baseline in Neuropsychiatric Inventory (NPI) at Week 104
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Assessment method [6]
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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).
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Timepoint [6]
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Baseline, Week 104
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Secondary outcome [7]
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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 through Week 104
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Assessment method [7]
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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).
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Timepoint [7]
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From Baseline through Week 104
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Secondary outcome [8]
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Change From Baseline in Brain tau Burden as Measured by tau PET at Week 104
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Assessment method [8]
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Change from baseline in brain tau burden, as measured by tau positron emission tomography (PET) will be assessed.
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Timepoint [8]
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Baseline, Week 104
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Secondary outcome [9]
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Change From Baseline in Cerebrospinal Fluid (CSF) concentrations of Total, Free, and Bound p217+tau Fragments at Week 104
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Assessment method [9]
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Change from baseline in CSF concentrations of total, free, and bound p217+tau (phosphorylated tau) fragments will be assessed.
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Timepoint [9]
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Baseline, Week 104
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Secondary outcome [10]
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CSF Concentrations of JNJ-63733657
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Assessment method [10]
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CSF concentrations of JNJ-63733657 will be assessed.
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Timepoint [10]
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At Weeks 52, 104, 208 (End of Treatment)
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Secondary outcome [11]
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Serum Concentrations of JNJ-63733657
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Assessment method [11]
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Serum concentrations of JNJ-63733657 will be assessed.
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Timepoint [11]
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At Weeks 4, 8, 12, 16, 20, 24, 36, 52, 76, 104, 128, 156, 180, 208, 232 (End of treatment)
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Secondary outcome [12]
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Anti-Drug Antibody to JNJ-63733657
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Assessment method [12]
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Anti-drug antibody to JNJ-63733657 will be assessed.
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Timepoint [12]
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Up to 245 Weeks (90 days [+-7 days] after last dose of study intervention)
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Secondary outcome [13]
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Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
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Assessment method [13]
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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.
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Timepoint [13]
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Up to 245 Weeks
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Secondary outcome [14]
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Number of Participants with Treatment-Emergent Adverse Event of Special Interest (AESI)
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Assessment method [14]
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Number of participants with a treatment-emergent AESI will be reported.
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Timepoint [14]
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Up to 245 Weeks
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Secondary outcome [15]
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Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
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Assessment method [15]
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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.
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Timepoint [15]
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Up to 245 Weeks
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Secondary outcome [16]
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Number of Participants with Electrocardiogram (ECG) Abnormalities
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Assessment method [16]
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Number of participants with ECG abnormalities will be reported.
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Timepoint [16]
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Up to 245 Weeks
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Secondary outcome [17]
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Number of Participants with Clinical Laboratory Abnormalities
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Assessment method [17]
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Number of participants with clinical laboratory (hematology, clinical chemistry, and urinalysis) abnormalities will be assessed.
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Timepoint [17]
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Up to 245 Weeks
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Secondary outcome [18]
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Number of Participants with Physical and Neurological Examination Abnormalities
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Assessment method [18]
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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.
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Timepoint [18]
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Up to 245 Weeks
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Secondary outcome [19]
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Percentage of Participants with Vital Sign Abnormalities
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Assessment method [19]
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Percentage of participants with vital sign abnormalities (temperature, pulse rate, systolic blood pressure [BP], diastolic BP) will be reported.
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Timepoint [19]
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Up to 245 Weeks
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Secondary outcome [20]
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Changes From Baseline in Brain Magnetic Resonance Imaging (MRI) Safety Findings
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Assessment method [20]
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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.
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Timepoint [20]
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Baseline and Up to 4.5 years (End of treatment)
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Secondary outcome [21]
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Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) score
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Assessment method [21]
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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).
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Timepoint [21]
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Baseline and Up to 245 Weeks
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Eligibility
Key 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
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Minimum age
55
Years
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/01/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/12/2032
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Actual
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Sample size
Target
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Accrual to date
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Final
523
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Box Hill Hospital - Box Hill
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Recruitment hospital [3]
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Neuro Trials Victoria - Carlton
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Recruitment hospital [4]
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Austin Health - Ivanhoe
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Recruitment hospital [5]
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HammondCare Neurodegenerative Clinical Trials - VIC - Malvern
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Recruitment hospital [6]
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Australian Alzheimer's Research Foundation Incorporated - Nedlands
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Recruitment hospital [7]
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Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3128 - Box Hill
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Recruitment postcode(s) [3]
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3053 - Carlton
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Recruitment postcode(s) [4]
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3079 - Ivanhoe
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Recruitment postcode(s) [5]
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3144 - Malvern
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Recruitment postcode(s) [6]
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6009 - Nedlands
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Recruitment postcode(s) [7]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Connecticut
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District of Columbia
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United States of America
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Florida
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Georgia
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Illinois
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Indiana
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Massachusetts
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Mississippi
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Pennsylvania
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Rhode Island
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Texas
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Vermont
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Virginia
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Belgium
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Brugge
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Belgium
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Brussels
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Hasselt
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Belgium
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Jette
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Belgium
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Leuven
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Belgium
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Roeselare
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Canada
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Ontario
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Canada
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Quebec
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France
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Bordeaux
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France
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Lille
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France
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Nantes
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France
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Paris
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France
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Rennes
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France
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Rouen
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France
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Toulouse
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France
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Tours
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Japan
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Aizuwakamatsu
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Japan
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Chiba-shi
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Japan
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Fujisawa-shi
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Japan
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Fukuoka
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Japan
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Hachioji
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Japan
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Himeji-city, Hyogo
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Japan
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Kamakura-shi
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Japan
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Kanzaki-gun
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Japan
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Kawasaki-shi
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0
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Japan
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Kobe-shi
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Japan
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Kurashiki-shi
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Japan
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Kurume
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0
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Japan
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Kyoto-shi
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Japan
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Kyoto
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Japan
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State/province [54]
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Narashino
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Japan
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Obu-shi
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Japan
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Shinjuku-ku
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Japan
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Tokyo
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Japan
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Toyonaka-shi
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Japan
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Yokohama-shi
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Country [60]
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Netherlands
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Amsterdam
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Netherlands
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Den Bosch
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Netherlands
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Leeuwarden
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Netherlands
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Zwolle
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Spain
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Algorta - Getxo
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Spain
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Barcelona
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Country [66]
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Spain
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Lleida
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Spain
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Madrid
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Spain
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Terrassa
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Spain
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Valencia
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Sweden
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Stockholm
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United Kingdom
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Bath
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04619420
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04619420
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