Open Actively Recruiting

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

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
55 Years
Maximum Age
80 Years

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

Join this Trial

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Study Stats
Protocol No.
21-001277
Category
Neurology
Principal Investigator
Contact
Thao Rodriguez
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04619420
For detailed technical eligibility, visit ClinicalTrials.gov.