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

Janssen (J&J Innovative Medicine)

Status and phase: Active, not recruiting; Phase 2

Conditions: Alzheimer Disease; Cognitive Dysfunction; Dementia

Treatments: Drug: JNJ-63733657; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04619420

63733657ALZ2002 (Other Identifier)

2022-501188-42-00 (Registry Identifier)

2020-000116-30 (EudraCT Number)

CR108832

Details and patient eligibility

About

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.

Enrollment: 523 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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523 participants in 3 patient groups, including a placebo group

JNJ-63733657 Low-dose

Experimental group

Description:

Participants will receive single dose of JNJ-63733657 low-dose administered by intravenous (IV) infusion every 4 weeks during the double-blind treatment period. Participants will have an option to continue with the long-term extension (LTE) phase of the trial and will continue to receive the same treatment and dose during the LTE treatment period.

Treatment:

Drug: JNJ-63733657

JNJ-63733657 High-dose

Experimental group

Description:

Participants will receive single dose of JNJ-63733657 high-dose administered by IV infusion every 4 weeks during double-blind treatment period. Participants will have an option to continue with the LTE phase of the trial and will continue to receive the same treatment and dose during the LTE treatment period.

Treatment:

Drug: JNJ-63733657

Placebo

Placebo Comparator group

Description:

Participants will receive single dose of matching placebo to JNJ-63733657 administered by IV infusion every 4 weeks during double-blind treatment period. Participants will have an option to continue with the LTE phase of the trial and will be re-randomized in a 1:1 ratio to receive either JNJ-63733657 low-dose or JNJ-63733657 high-dose during the LTE treatment period.

Treatment:

Drug: Placebo