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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Alzheimer Disease, Cognitive Dysfunction, Dementia

In brief

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.

Key facts

Study ID

NCT04619420

Run by

Janssen Research & Development, LLC

People needed

523

Starts

2021-01-06

Expected to finish

2026-03-03

Last updated by the study team

2026-04-03

Who can join

Age: 55 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dignity Health — Phoenix, Arizona, United States
• Irvine Clinical Research — Irvine, California, United States
• University of California San Diego Medical Center — La Jolla, California, United States
• University of California - Los Angeles — Los Angeles, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Pacific Research Network Prn — San Diego, California, United States
• Syrentis Clinical Research — Santa Ana, California, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• Georgetown University Clinical Research Unit CRU — Washington D.C., District of Columbia, United States
• JEM Research LLC — Atlantis, Florida, United States
• Brain Matters Research — Delray Beach, Florida, United States
• Neuropsychiatric Research Center of SWFL — Fort Myers, Florida, United States
• Clinical NeuroScience Solutions Inc — Jacksonville, Florida, United States
• Alphab Global Research — Jupiter, Florida, United States
• K2 Medical Research — Maitland, Florida, United States
• Tandem Intermediate LLC — Maitland, Florida, United States
• Merritt Island Medical Research, LLC — Merritt Island, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Miami Jewish Health System — Miami, Florida, United States
• Aqualane Clinical Research — Naples, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Sensible Healthcare — Ocoee, Florida, United States
• Axiom Clinical Research of Florida — Tampa, Florida, United States
• Stedman Clinical Trials — Tampa, Florida, United States
• University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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