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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04619420




Registration number
NCT04619420
Ethics application status
Date submitted
5/11/2020
Date registered
6/11/2020

Titles & IDs
Public title
A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease
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
Secondary ID [1] 0 0
2020-000116-30
Secondary ID [2] 0 0
CR108832
Universal Trial Number (UTN)
Trial acronym
Autonomy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Cognitive Dysfunction 0 0
Dementia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Total Score at Week 104
Timepoint [1] 0 0
Week 104
Secondary outcome [1] 0 0
Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive subscale 13-item version (ADAS-Cog 13) Total Score at Week 104
Timepoint [1] 0 0
Week 104
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Week 104
Secondary outcome [3] 0 0
Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index Score at Week 88
Timepoint [3] 0 0
Baseline, Week 88
Secondary outcome [4] 0 0
Change From Baseline in RBANS Indices at Week 88
Timepoint [4] 0 0
Baseline, Week 88
Secondary outcome [5] 0 0
Change From Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) at Week 104
Timepoint [5] 0 0
Baseline, Week 104
Secondary outcome [6] 0 0
Change from Baseline in Neuropsychiatric Inventory (NPI) at Week 104
Timepoint [6] 0 0
Baseline, Week 104
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
From Baseline through Week 104
Secondary outcome [8] 0 0
Change From Baseline in Brain tau Burden as Measured by tau PET at Week 104
Timepoint [8] 0 0
Baseline, Week 104
Secondary outcome [9] 0 0
Change From Baseline in Cerebrospinal Fluid (CSF) concentrations of Total, Free, and Bound p217+tau Fragments at Week 104
Timepoint [9] 0 0
Baseline, Week 104
Secondary outcome [10] 0 0
CSF Concentrations of JNJ-63733657
Timepoint [10] 0 0
At Weeks 52, 104, 208 (End of Treatment)
Secondary outcome [11] 0 0
Serum Concentrations of JNJ-63733657
Timepoint [11] 0 0
At Weeks 4, 8, 12, 16, 20, 24, 36, 52, 76, 104, 128, 156, 180, 208, 232 (End of treatment)
Secondary outcome [12] 0 0
Anti-Drug Antibody to JNJ-63733657
Timepoint [12] 0 0
Up to 245 Weeks (90 days [+-7 days] after last dose of study intervention)
Secondary outcome [13] 0 0
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Timepoint [13] 0 0
Up to 245 Weeks
Secondary outcome [14] 0 0
Number of Participants with Treatment-Emergent Adverse Event of Special Interest (AESI)
Timepoint [14] 0 0
Up to 245 Weeks
Secondary outcome [15] 0 0
Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Timepoint [15] 0 0
Up to 245 Weeks
Secondary outcome [16] 0 0
Number of Participants with Electrocardiogram (ECG) Abnormalities
Timepoint [16] 0 0
Up to 245 Weeks
Secondary outcome [17] 0 0
Number of Participants with Clinical Laboratory Abnormalities
Timepoint [17] 0 0
Up to 245 Weeks
Secondary outcome [18] 0 0
Number of Participants with Physical and Neurological Examination Abnormalities
Timepoint [18] 0 0
Up to 245 Weeks
Secondary outcome [19] 0 0
Percentage of Participants with Vital Sign Abnormalities
Timepoint [19] 0 0
Up to 245 Weeks
Secondary outcome [20] 0 0
Changes From Baseline in Brain Magnetic Resonance Imaging (MRI) Safety Findings
Timepoint [20] 0 0
Baseline and Up to 4.5 years (End of treatment)
Secondary outcome [21] 0 0
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) score
Timepoint [21] 0 0
Baseline and Up to 245 Weeks

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
Minimum age
55 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2032
Actual
Sample size
Target
Accrual to date
Final
523
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 0 0
Neuro Trials Victoria - Carlton
Recruitment hospital [4] 0 0
Austin Health - Ivanhoe
Recruitment hospital [5] 0 0
HammondCare Neurodegenerative Clinical Trials - VIC - Malvern
Recruitment hospital [6] 0 0
Australian Alzheimer's Research Foundation Incorporated - Nedlands
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3053 - Carlton
Recruitment postcode(s) [4] 0 0
3079 - Ivanhoe
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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California
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Connecticut
Country [5] 0 0
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District of Columbia
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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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Edegem
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Kanzaki-gun
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Kawasaki
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Kurume
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Kyoto
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Narashino
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Tokyo
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Yokohama-shi
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Amsterdam
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Den Bosch
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Zwolle
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Algorta - Getxo
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Bath
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04619420