The trial is taking place at:
R

Renstar Medical Research | Ocala, FL

Veeva-enabled site

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

J

Janssen (J&J Innovative Medicine)

Status and phase

Active, not recruiting
Phase 2

Conditions

Alzheimer Disease
Cognitive Dysfunction
Dementia

Treatments

Drug: Placebo
Drug: JNJ-63733657

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

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

Trial contacts and locations

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Central trial contact

Study Contact

Data sourced from clinicaltrials.gov

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