A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease (NCT04619420) | Clinical Trial Compass
TerminatedPhase 2
A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease
Stopped: Posdinemab did not achieve statistical significance in slowing clinical decline
United States523 participantsStarted 2021-01-06
Plain-language 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.
Who can participate
Age range55 Years – 80 Years
SexALL
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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 sys…
What they're measuring
1
Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Total Score at Week 104