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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06544616
Registration number
NCT06544616
Ethics application status
Date submitted
6/08/2024
Date registered
9/08/2024
Date last updated
22/06/2025
Titles & IDs
Public title
A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease
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Scientific title
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study, to Assess Efficacy, Safety and Immunogenicity of JNJ-64042056, a Phosphorylated Tau Targeted Active Immunotherapy, in Participants With Preclinical Alzheimer's Disease
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Secondary ID [1]
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64042056ALZ2001
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Secondary ID [2]
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64042056ALZ2001
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Universal Trial Number (UTN)
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Trial acronym
Retain
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Preclinical Alzheimer's Disease
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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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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - JNJ-64042056
Treatment: Drugs - Placebo
Experimental: Arm A: JNJ-64042056 - Participants will receive intramuscular (IM) injection of JNJ-64042056 from Week 0 until Week 180.
Placebo comparator: Arm B: Placebo - Participants will receive IM injection of placebo from Week 0 until Week 180.
Treatment: Drugs: JNJ-64042056
JNJ-64042056 will be administered intramuscularly.
Treatment: Drugs: Placebo
Placebo will be administered intramuscularly.
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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 Preclinical Alzheimer's Disease Cognitive Composite 5 (PACC-5) Total Scores up to Week 206
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Assessment method [1]
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Cognition will be measured using the PACC-5 scale, which includes 5 components: free/cued selective reminding test, delayed paragraph recall (logical memory test), digit-symbol substitution test, mini mental state examination, and the category fluency test (CFT). PACC-5 is a composite score which provides unique information about early cognitive decline not currently captured by the episodic memory, executive function, and global cognition components. The score reflects an averaged z-score, with higher scores indicating better cognitive performance.
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Timepoint [1]
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Baseline up to Week 206
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Secondary outcome [1]
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Change From Baseline in Brain tau Burden as Measured by tau PET
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Assessment method [1]
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Change from baseline in brain tau burden as measured by tau positron emission tomography (PET) in the Tau naive composite region of interest (ROI) at Weeks 102, 154 and 206 will be reported.
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Timepoint [1]
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Baseline and Weeks 102, 154 and 206
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Secondary outcome [2]
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Change From Baseline in PACC-5 Individual Domain Scores
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Assessment method [2]
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Cognition will be measured using the PACC-5 scale, which includes 5 components: free/cued selective reminding test, delayed paragraph recall (logical memory test), digit-symbol substitution test, mini mental state examination, and the category fluency test (CFT). PACC-5 is a composite score which provides unique information about early cognitive decline not currently captured by the episodic memory, executive function, and global cognition components. The score reflects an averaged z-score, with higher scores indicating better cognitive performance.
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Timepoint [2]
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Baseline up to Week 206
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Secondary outcome [3]
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Time to Event of Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS)
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Assessment method [3]
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Time to event of clinical progression as measured by clinical dementia rating-global score (CDR-GS) will be reported. The CDR assesses 3 domains of cognition (memory, orientation, judgment/problem solving) and 3 domains of function (community affairs, home/hobbies, personal care) using semi-structured interviews of both the study participant and the study partner carried out by a trained rater. Each domain is rated on a 5-point scale of functioning as follows: (0) no impairment; (0.5) questionable impairment; (1) mild impairment; (2) moderate impairment; and (3) severe impairment (Personal care is scored on a 4-point scale without a 0.5 rating available). CDR Global score ranging from 0 to 3, with 0 indicating no signs of clinically apparent cognitive impairment or dementia and 3 indicating severe dementia.
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Timepoint [3]
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Baseline up to Week 206
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Secondary outcome [4]
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Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Scores
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Assessment method [4]
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CDR assesses 3 domains of cognition (memory, orientation, judgment/problem solving) and 3 domains of function (community affairs, home/hobbies, personal care) using semi-structured interviews of both the study participant and the study partner carried out by a trained rater. Each domain is rated on a 5-point scale of functioning as follows: (0) no impairment; (0.5) questionable impairment; (1) mild impairment; (2) moderate impairment; and (3) severe impairment (Personal care is scored on a 4-point scale without a 0.5 rating available). Scores of the 6 domains (ranging from 0 to 3) summed to obtain the CDR. Sum of Boxes CDR-SB score with scores ranging from 0 to 18 where higher scores indicates greater impairment.
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Timepoint [4]
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Baseline up to Week 206
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Secondary outcome [5]
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Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVR) Biomarkers (tau Naive Composite ROI and Other ROIs)
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Assessment method [5]
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Change from baseline in Tau PET SUVR in the tau naive composite ROI and other ROIs will be reported.
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Timepoint [5]
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Baseline up to Week 206
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Secondary outcome [6]
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Change From Baseline in p217+tau
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Assessment method [6]
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Change from baseline in p217+tau will be reported.
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Timepoint [6]
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Baseline up to Week 206
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Secondary outcome [7]
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Change From Baseline in PACC-5 Total Score
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Assessment method [7]
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Change from baseline in PACC-5 total score will be reported.
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Timepoint [7]
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Baseline up to Week 180
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Secondary outcome [8]
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Change From Baseline in Brain Tau Burden as Measured by Tau PET in Other ROI
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Assessment method [8]
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Change from baseline in brain tau burden, as measured by tau PET (including but not limited to Braak I-VI ROIs, Connection Rank ROI, and New Tau Composite ROI Volume) will be reported.
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Timepoint [8]
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Baseline up to Week 206
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Secondary outcome [9]
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Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living -Prevention Instrument (ADCS-ADL-PI)
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Assessment method [9]
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The ADCS-ADL-PI is a functional measure composed of 18 items that include 15 activities of daily living rated on a 4-point scale and 3 high-level function items. Study participants and their study partners independently rate the participant's level of ability. Study partners are additionally asked to evaluate whether activities were completed less often, required more time to complete, and if any errors were made performing the task. High-level function items are rated as "yes" or "no". Total scores range from 0 to 45 with higher scores indicating less impairment.
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Timepoint [9]
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Baseline up to Week 206
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Secondary outcome [10]
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Change From Baseline in Mild Behavioral Impairment Checklist (MBI-C) Score
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Assessment method [10]
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MBI-C is a 2-page questionnaire consisting of 34 items, in 5 domains. The apathy domain consists of 6 questions including assessments of cognitive, behavioral and emotional apathy. The affect domain contains 6 items, including 4 for depressive features of low mood, anhedonia, hopelessness, and guilt, and 1 question each for worry and panic. The impulse dyscontrol domain is the largest, with 12 questions describing agitation, aggression, impulsivity, recklessness, and abnormal reward and reinforcement. The social appropriateness domain consists of 5 questions assessing sensitivity, empathy, and tact. Finally, the abnormal thought and perception domain consists of 5 questions assessing suspiciousness, grandiosity, and auditory and visual hallucinations.
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Timepoint [10]
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Baseline up to Week 206
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Secondary outcome [11]
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Change From Baseline in the Quality of Life- Alzheimer's Disease (QoL-AD)
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Assessment method [11]
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QoL-AD is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). It evaluates the caregiver's own perceived quality of life. Total score ranges from 13 to 52. Higher scores represent a better outcome.
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Timepoint [11]
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Baseline up to Week 206
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Secondary outcome [12]
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Change From Baseline in European Quality of Life-5 Dimensions 5-Levels (EQ-5D-5L) Score
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Assessment method [12]
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The EQ-5D-5L essentially consists of 2 elements: the European Quality of Life-5 Dimensions (EQ-5D) descriptive system and the European Quality visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems. The digits for the 5 dimensions can be combined in a 5-digit number describing the respondent's health state which can be converted into a single summary index (EQ-5D index) by applying a formula that attaches values to each of the levels in each dimension. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labeled Best imaginable health state and Worst imaginable health state. The EQ VAS can be used as a quantitative measure of health outcome as judged by the individual respondents
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Timepoint [12]
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Baseline up to Week 206
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Secondary outcome [13]
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Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score
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Assessment method [13]
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RUD-Lite assesses the healthcare resource utilization of participants and their study partners and determines the level of formal and informal care attributable to Alzheimer's disease (AD). It assesses time spent in assisting participants with basics such as dressing, bathing and instrumental activities of daily living (ADLs) such as shopping and cooking. The RUD-Lite results can be used for calculating cost offsets and cost effectiveness modeling.
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Timepoint [13]
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Baseline up to Week 206
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Secondary outcome [14]
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Levels of IgG Titers Against Enriched Paired Helical Filaments (ePHF), p-tau and tau in Serum
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Assessment method [14]
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Levels of IgG titers against ePHF, p-tau peptide and tau peptide in serum will be measured.
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Timepoint [14]
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Up to Week 206
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Secondary outcome [15]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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Assessment method [15]
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An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical or biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
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Timepoint [15]
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Up to Week 208
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Secondary outcome [16]
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Number of Participants With Reactogenicity
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Assessment method [16]
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Solicited AEs will be used to assess the reactogenicity of the active immunotherapy and are predefined local (at the injection site) and systemic events for which the participant is specifically questioned, and which are noted by participants in their participant diary.
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Timepoint [16]
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Up to Week 182
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Secondary outcome [17]
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Change from Baseline in Vital Signs
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Assessment method [17]
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Change from baseline in vital signs including temperature and blood pressure (systolic and diastolic) (supine) will be summarized over time.
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Timepoint [17]
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Baseline up to Week 206
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Secondary outcome [18]
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Change From Baseline in Clinical Laboratory Values
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Assessment method [18]
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Change from baseline in clinical laboratory values (chemistry, hematology, urinalysis) will be reported.
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Timepoint [18]
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Baseline up to Week 206
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Secondary outcome [19]
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Change from Baseline in Electrocardiogram (ECG) Values
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Assessment method [19]
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Change from baseline in ECG values will be reported.
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Timepoint [19]
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Baseline up to Week 206
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Secondary outcome [20]
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Change From Baseline in Columbia-Suicidality Severity Rating Scale (C-SSRS)
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Assessment method [20]
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A frequency distribution of C-SSRS scores at each scheduled time point by treatment will be provided. Shifts from the baseline visit to the most severe/maximum score during the treatment period will be summarized by treatment. The maximum score assigned for each participant will also be summarized into 1 of 3 categories: no suicidal ideation or behavior (0), suicidal ideation (1 to 5), suicidal behavior (6 to 10).
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Timepoint [20]
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Baseline up to Week 206
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Secondary outcome [21]
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Change From Baseline in Magnetic Resonance Imaging (MRI) Findings
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Assessment method [21]
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Change from baseline in brain MRI safety findings will be reported.
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Timepoint [21]
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Baseline up to Week 206
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Eligibility
Key inclusion criteria
* Elevated brain tau pathology defined as Braak 3 region of interest standardized uptake value ratio (ROI SUVR) greater than (>) 1.1 on a screening tau PET scan, reviewed centrally by a qualified reader
* Clinical Dementia Rating (CDR) global score of 0 at screening and baseline
* Mini Mental State Examination (MMSE) greater than or equal to (>=) 27 (with educational adjustment)
* Able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening
* A participant must be of non-childbearing potential
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Minimum age
55
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Maximum age
75
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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
* History consistent with or known autosomal dominant AD (mutation identified in the family and/or participant)
* Fulfills diagnostic criteria for Alzheimer's Dementia or non-Alzheimer's Dementia, including, but not limited to Frontotemporal Dementia (FTD), Diffuse Lewy Body Dementia (DLBD), Vascular Dementia (VAD), alcoholic dementia, Parkinson's dementia, Korsakov, Creutzfeldt-Jakob or other prion diseases, Posterior Cortical Atrophy
* Diagnosis of Mild Cognitive Impairment (MCI)
* Vitamin B12 or folate levels below the central laboratory lower limit of normal, unless in the opinion of the investigator it does not require treatment
* History of or current neurological disease other than preclinical AD that may make interpretation of possible new neurological signs or symptoms difficult
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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 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
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
22/07/2024
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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
7/07/2034
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Actual
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Sample size
Target
498
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Neuro Trials Victoria - Carlton
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Recruitment hospital [2]
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The Prince Charles Hospital - Chermside
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St Vincent's Centre for Applied Medical Research - Darlinghurst
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Austin Health Heidelberg Repatriation Hospital - Ivanhoe
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Southern Neurology - Kogarah
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Recruitment hospital [6]
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KaRa Institute of Neurological Diseases - Macquarie Park
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Recruitment hospital [7]
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Australian Alzheimer's Research Foundation Incorporated - Nedlands
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Recruitment postcode(s) [1]
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3053 - Carlton
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Recruitment postcode(s) [2]
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4032 - Chermside
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Recruitment postcode(s) [3]
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2010 - Darlinghurst
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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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2217 - Kogarah
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Recruitment postcode(s) [6]
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2113 - Macquarie Park
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Illinois
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Michigan
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Mississippi
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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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Vermont
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Virginia
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France
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Toulouse
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Germany
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Köln
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Japan
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Chofu-shi
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Chuo-ku
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Japan
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Hirakata-shi
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Kobe City
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Kobe
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Musashimurayama
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Narashino-shi
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Shinjuku ku
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Shinjuku-ku
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Shinjyuku Ku
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Suita shi
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Toyonaka-shi
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Barcelona
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Getxo
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Madrid
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Pamplona
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Pozuelo de Alarcón
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Terrassa
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Spain
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Zaragoza
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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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Birmingham
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Bristol
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Edinburgh
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Guildford
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London
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Oxford
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Plymouth
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United Kingdom
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Southampton
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United Kingdom
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Winchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Pharmaceutica N.V., Belgium
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the effect of JNJ-64042056 on cognitive decline, as measured by Preclinical Alzheimer's disease Cognitive Composite 5 (PACC-5) compared with placebo.
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Trial website
https://clinicaltrials.gov/study/NCT06544616
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Pharmaceutica N.V., Belgium Clinical trial
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Address
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Janssen Pharmaceutica N.V., Belgium
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Study Contact
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Address
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Country
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Phone
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844-434-4210
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
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/NCT06544616
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