Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
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 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