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

• Status: Recruiting
• Trial end date: 2025-03-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC

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 during the study and up to 16 weeks after the last dose of study intervention

Exclusion Criteria:

• Participants with CDR GS >=2 at predose baseline 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 (eg, MCI/dementia due to frontotemporal lobar degeneration, diffuse lewy body disease, 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 >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. Chronic use of benzodiazepines is not permitted