Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06544616 · ClinicalTrials.gov registry record · Phase 2
A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease
A Phase 2 study of Preclinical Alzheimer's Disease, sponsored by Janssen Pharmaceutica N.V., Belgium.
- Active
- Registry status
- Phase 2
- Development phase
- 498
- Enrollment target
- 20
- Study locations
NCT06544616: Active Phase 2 study of Preclinical Alzheimer's Disease, sponsored by Janssen Pharmaceutica N.V., Belgium.
NCT06544616 is a Phase 2 study of Preclinical Alzheimer's Disease that is active but no longer recruiting, run by Janssen Pharmaceutica N.V., Belgium. The registered enrollment target is 498 participants, below the 813-participant average among 3 other Preclinical Alzheimer's Disease trials with a reported enrollment target (39% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06544616, a Phase 2 study of Preclinical Alzheimer's Disease, is active but no longer recruiting, sponsored by Janssen Pharmaceutica N.V., Belgium.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 498 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the effect of JNJ-64042056 on cognitive decline, as measured by Preclinical Alzheimer's disease Cognitive Composite 5 (PACC-5) compared with placebo.
Primary Outcome
Change from baseline in brain tau burden, as measured by tau PET (including but not limited to Braak I-VI ROIs, tau naive composite ROI, Connection Rank ROI, and New Tau Composite ROI Volume) will be reported.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG JNJ-64042056
Study Locations (20)
Florida
- JEM Research LLC - Atlantis
- Excel Medical Clinical Trials, LLC - Boca Raton
- K2 Medical Research Winter Garden - Clermont
- Clinical NeuroScience Solutions Inc - Jacksonville
- K2 Medical Research - Lady Lake
- K2 Medical Research - Maitland
- Merritt Island Medical Research, LLC - Merritt Island
- Headlands Research Orlando - Orlando
- Alzheimers Research and Treatment Center - Stuart
- K2 Medical Research - Tampa
- Charter Research - The Villages
- Alzheimers Research and Treatment Center - Wellington
- Palm Beach Neurology and Premier Research Institute - West Palm Beach
California
- Irvine Clinical Research - Irvine
- Esperanza Clinical - Murrieta
- Artemis Institute for Clinical Research - Riverside
- Artemis Institute for Clinical Research - San Diego
Arizona
- Xenoscience Inc. - Phoenix
Connecticut
- Yale University School Of Medicine - New Haven
Illinois
- Great Lakes Clinical Trials - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 498 participants |
| Start Date | 2024-07-22 |
| Est. Completion | 2032-07-16 |
| Phase | Phase 2 |
What the registry record for NCT06544616 still lists
NCT06544616 is an interventional study that assigns participants to a tested intervention. The registered 498 participants enrollment target is mid-sized for trials with a published cap, below the 813-participant average among 3 other Preclinical Alzheimer's Disease trials with a reported enrollment target (39% lower).
The record links to 1 condition, with Preclinical Alzheimer's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06544616 names 20 study sites across 5 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06544616 about?
NCT06544616 is a clinical study titled "A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease". The purpose of this study is to assess the effect of JNJ-64042056 on cognitive decline, as measured by Preclinical Alzheimer's disease Cognitive Composite 5 (PACC-5) compared with placebo.
What is the current status of trial NCT06544616?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 498 participants. The study started on 2024-07-22. Estimated completion is 2032-07-16.
What conditions does trial NCT06544616 study?
This clinical trial studies the following conditions: Preclinical Alzheimer's Disease.
What interventions are being tested in trial NCT06544616?
The interventions under investigation include: Placebo (DRUG), JNJ-64042056 (DRUG).
Who is sponsoring clinical trial NCT06544616?
This trial is sponsored by Janssen Pharmaceutica N.V., Belgium, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06544616 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Preclinical Alzheimer's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Alzheimer's Plasma Extension
ACTIVE NOT RECRUITING
-
AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid
ACTIVE NOT RECRUITING · Phase 3
-
Concurrent Aerobic Exercise and Virtual Reality Cognitive Training
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04137900 · 499 participants · Phase 1
Safety, Tolerability and Pharmacokinetics of a Monoclonal Antibody Specific to B-and T-Lymphocyte Attenuator (BTLA) as Monotherapy and in Combination With an Anti-PD1 Monoclonal Antibody for Injection in Subjects With Advanced Malignancies
- NCT06733480 · 499 participants · NA
Innovating Physical Therapy: A Pilot Study on Band Connect's Impact on Compliance, Satisfaction, and Revenue
- NCT03175224 · 497 participants · Phase 2
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
- NCT05301816 · 497 participants · NA
PDN Post Market, Multicenter, Prospective, Global Clinical Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI