A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease
Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Nov 5, 2020
Trial Information
Current as of April 30, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called JNJ-63733657 to see how it affects people with early Alzheimer's disease. Researchers want to find out if this medication can help slow down the decline in thinking and daily functioning compared to a placebo, which is a look-alike pill with no active medicine. The study will include participants who have noticed a gradual decline in their memory and thinking skills over the past six months and have specific results from brain scans that show changes related to Alzheimer's disease.
To be eligible for this trial, participants must be diagnosed with early Alzheimer's disease, have a study partner to help them throughout the study, and be able to read and write. They should not have other types of dementia or cognitive issues that are not caused by Alzheimer's. If someone joins the study, they will receive either the JNJ-63733657 treatment or a placebo and will be monitored closely to see how their condition changes over time. It's important to note that participants will need to avoid certain medications that affect the brain for at least two months before the study begins.
Gender
ALL
Eligibility 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 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
About Janssen Research & Development, Llc
Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Albany, New York, United States
Boston, Massachusetts, United States
New York, New York, United States
Saint Louis, Missouri, United States
Providence, Rhode Island, United States
Boston, Massachusetts, United States
Rouen, , France
Chicago, Illinois, United States
Birmingham, Alabama, United States
Indianapolis, Indiana, United States
Los Alamitos, California, United States
New Haven, Connecticut, United States
Raleigh, North Carolina, United States
Albany, New York, United States
Los Angeles, California, United States
Northbrook, Illinois, United States
Tampa, Florida, United States
Parkville, , Australia
Charlottesville, Virginia, United States
Palo Alto, California, United States
Delray Beach, Florida, United States
Bath, , United Kingdom
Princeton, New Jersey, United States
Tampa, Florida, United States
Kurume, , Japan
London, , United Kingdom
Gent, , Belgium
Birmingham, Alabama, United States
Miami, Florida, United States
Adelaide, , Australia
Paris, , France
Leuven, , Belgium
La Jolla, California, United States
Edegem, , Belgium
Jette, , Belgium
Memphis, Tennessee, United States
Hattiesburg, Mississippi, United States
Boston, Massachusetts, United States
East Providence, Rhode Island, United States
Tokyo, , Japan
Atlantis, Florida, United States
Toronto, Ontario, Canada
Madrid, , Spain
Washington, District Of Columbia, United States
Kyoto, , Japan
Sun City, Arizona, United States
Stockholm, , Sweden
Atlantis, Florida, United States
San Antonio, Texas, United States
Fukuoka, , Japan
Brugge, , Belgium
Peterborough, Ontario, Canada
Montreal, Quebec, Canada
Tours, , France
Rotterdam, , Netherlands
Mount Arlington, New Jersey, United States
Melbourne, Victoria, Australia
Winston Salem, North Carolina, United States
Jacksonville, Florida, United States
Toms River, New Jersey, United States
London, Ontario, Canada
Barcelona, , Spain
Santa Ana, California, United States
Hasselt, , Belgium
Chicago, Illinois, United States
Tampa, Florida, United States
Columbus, Ohio, United States
Box Hill, , Australia
Miami, Florida, United States
Ocoee, Florida, United States
Ocala, Florida, United States
Jacksonville, Florida, United States
Barcelona, , Spain
Tokyo, , Japan
Atlanta, Georgia, United States
Jönköping, , Sweden
Kobe Shi, , Japan
Roeselare, , Belgium
Valencia, , Spain
Lille, , France
Winter Park, Florida, United States
Barcelona, , Spain
Jupiter, Florida, United States
Naples, Florida, United States
Houston, Texas, United States
Kanzaki Gun, , Japan
Noble Park, , Australia
Phoenix, Arizona, United States
Terrassa, , Spain
Kawasaki, , Japan
Barcelona, , Spain
Lady Lake, Florida, United States
Nantes, , France
Irvine, California, United States
West Palm Beach, Florida, United States
Bordeaux, , France
Elk Grove Village, Illinois, United States
Merritt Island, Florida, United States
East Syracuse, New York, United States
Saint Louis, Missouri, United States
Tucson, Arizona, United States
San Diego, California, United States
Fort Myers, Florida, United States
Maitland, Florida, United States
Orlando, Florida, United States
Viera, Florida, United States
Wellington, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Braintree, Massachusetts, United States
Cleveland, Ohio, United States
Plymouth Meeting, Pennsylvania, United States
Willow Grove, Pennsylvania, United States
Providence, Rhode Island, United States
Bennington, Vermont, United States
Ivanhoe, , Australia
Malvern, , Australia
Nedlands, , Australia
Brussels, , Belgium
Liège, , Belgium
Burlington, Ontario, Canada
London, Ontario, Canada
Toronto, , Canada
Paris, , France
Rennes, , France
Toulouse, , France
Aizuwakamatsu, , Japan
Chiba Shi, , Japan
Fujisawa Shi, , Japan
Hachioji, , Japan
Himeji City, Hyogo, , Japan
Kamakura Shi, , Japan
Kawasaki Shi, , Japan
Kurashiki Shi, , Japan
Kyoto Shi, , Japan
Narashino, , Japan
Obu Shi, , Japan
Shinjuku Ku, , Japan
Shizuoka Shi, , Japan
Toyonaka Shi, , Japan
Toyonaka Shi, , Japan
Yokohama Shi, , Japan
Amsterdam, , Netherlands
Den Bosch, , Netherlands
Leeuwarden, , Netherlands
Zwolle, , Netherlands
Algorta Getxo, , Spain
Barcelona, , Spain
Barcelona, , Spain
Lleida, , Spain
Cambridge, , United Kingdom
London, , United Kingdom
Plymouth Meeting, Pennsylvania, United States
Maitland, Florida, United States
East Syracuse, New York, United States
Naples, Florida, United States
Carlton, , Australia
Algorta Getxo, , Spain
Barcelona, , Spain
The Villages, Florida, United States
The Villages, Florida, United States
Bordeaux, , France
Toronto, Ontario, Canada
Rennes, , France
Zwolle, , Netherlands
Himeji City, , Japan
Maitland, Florida, United States
Toyonaka Shi, , Japan
Patients applied
Trial Officials
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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