An Extension Study to Evaluate the Long-Term Safety and Tolerability of JNJ-54861911 in Participants in the Early Alzheimer's Disease Spectrum

NCT ID: NCT02406027

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-02
• Study Completion Date: 2018-06-28

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of JNJ-54861911 in participants in the early Alzheimer's disease (AD [progressive brain disease that slowly destroys memory and thinking skills, and eventually even the ability to carry out the simplest tasks]) spectrum that have completed a Phase 1b or Phase 2 clinical trial with JNJ-54861911, who are willing to continue their assigned treatment.

Detailed Description

Participants in the early Alzheimer's Disease (AD) spectrum, enrolled in ongoing or future clinical trials with JNJ-54861911 (Phase 1b or Phase 2 studies) will be provided the opportunity to participate in this study upon completion of their treatment period under the parent protocol. The study will consist of a Screening phase and 2 sequential treatment phases (a 12-month double-blind [DB] treatment phase [placebo controlled] and an open-label [OL] phase [active]) followed by an End-of-Treatment visit. Treatment in OL phase will continue until registration of JNJ-54861911; unless safety issues emerge as determined by the Data Review Committee (DRC) that would warrant termination of the study. Blood and cerebrospinal fluid (CSF) samples will be collected to evaluate the plasma and CSF pharmacokinetics of JNJ-54861911, as well as amyloid beta fragments. Participants' safety will be monitored throughout the study.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Double-blind Treatment Phase: JNJ-54861911, 10 mg

Participants will continue with their current treatment regimen (10 milligram \[mg\] of JNJ-54861911) established in the parent study of JNJ-54861911. Participants will receive 10 milligram (mg) of JNJ-54861911 orally, once daily from Day 1 up Week 52 in the DB treatment phase.

Group Type: EXPERIMENTAL

JNJ-54861911, 10 mg

Intervention Type: DRUG

Participants will self-administer JNJ-54861911 tablet, 10 mg (2\*5 mg), orally, once daily.

Double-blind Treatment Phase: JNJ-54861911, 25 mg

Participants will continue with their current treatment regimen (25 mg of JNJ-54861911) established in the parent study of JNJ-54861911. Participants will receive 25 mg of JNJ-54861911 orally, once daily from Day 1 up Week 52 in the DB treatment phase.

Group Type: EXPERIMENTAL

JNJ-54861911, 25 mg

Intervention Type: DRUG

Participants will self-administer 1 tablet of JNJ-54861911, containing 25 mg orally, once daily.

Double-blind Treatment Phase: Placebo

Participants will continue with their current treatment regimen established in the parent study of JNJ-54861911. Participants will receive placebo matching to JNJ-54861911 orally, once daily from Day 1 up Week 52 in the DB treatment phase.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will self administer placebo matching to JNJ-54861911 orally once daily.

Open-label Phase: JNJ-54861911, 5 mg

Participants who were receiving JNJ-54861911, 10 mg and placebo in the DB treatment phase, will receive the 5 mg JNJ-54861911 once daily up to end of treatment visit (until registration of JNJ-54861911 or any safety issue) in Open-label phase.

Group Type: ACTIVE_COMPARATOR

JNJ-54861911, 10 mg

Intervention Type: DRUG

Participants will self-administer JNJ-54861911 tablet, 10 mg (2\*5 mg), orally, once daily.

JNJ-54861911, 5 mg

Intervention Type: DRUG

Participants will self-administer JNJ-54861911 tablet, 5 mg, orally, once daily.

Open-label Phase: JNJ-54861911, 25 mg

Participants who were receiving JNJ-54861911, 25 mg in the DB treatment phase, will continue to receive the same regimen in open-label treatment phase. Participants who were receiving placebo in the DB treatment phase will be randomly assigned to receive 25 mg of JNJ-54861911 once daily up to end of treatment visit (until registration of JNJ-54861911 or any safety issue) in the open-label treatment phase.

Group Type: ACTIVE_COMPARATOR

JNJ-54861911, 25 mg

Intervention Type: DRUG

Participants will self-administer 1 tablet of JNJ-54861911, containing 25 mg orally, once daily.

Interventions

JNJ-54861911, 10 mg

Participants will self-administer JNJ-54861911 tablet, 10 mg (2\*5 mg), orally, once daily.

Intervention Type: DRUG

JNJ-54861911, 25 mg

Participants will self-administer 1 tablet of JNJ-54861911, containing 25 mg orally, once daily.

Intervention Type: DRUG

Placebo

Participants will self administer placebo matching to JNJ-54861911 orally once daily.

Intervention Type: DRUG

JNJ-54861911, 5 mg

Participants will self-administer JNJ-54861911 tablet, 5 mg, orally, once daily.

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
• Each Participants (or their legally acceptable representative and caregiver depending on disease state and local requirements) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
• Participants must have a reliable informant (relative, partner, or friend). The informant must be willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or other audio/visual communication). The informant must have sufficient contact such that the Investigator feels he/she can provide meaningful information about the participant's daily function. If possible, an alternate informant meeting these criteria who can replace the primary informant should be identified prior to randomization

• Any condition or situation which, in the opinion of the Investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with participant's participation in the study
• The use of concomitant medications known to prolong the QT/QTc interval
• Participant has a history of moderate or severe hepatic impairment or severe renal insufficiency unless completely resolved for more than a year. Participant has clinically significant ongoing hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, hematologic, rheumatologic, psychiatric or metabolic conditions (e.g., requiring frequent monitoring or medication adjustments or is otherwise unstable)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_CHAIR

Janssen Research & Development, LLC

Locations

Ghent, , Belgium

Hoboken, , Belgium

Montpellier, , France

Paris, , France

Toulouse, , France

Essen, , Germany

Homburg, , Germany

Lübeck, , Germany

Tübingen, , Germany

Ulm, , Germany

Amsterdam, , Netherlands

Barcelona, , Spain

Madrid, , Spain

Terrasa Barcelona, , Spain

Valencia, , Spain

Mölndal, , Sweden

Stockholm, , Sweden

Countries

Belgium; France; Germany; Netherlands; Spain; Sweden

References

Novak G, Streffer JR, Timmers M, Henley D, Brashear HR, Bogert J, Russu A, Janssens L, Tesseur I, Tritsmans L, Van Nueten L, Engelborghs S. Long-term safety and tolerability of atabecestat (JNJ-54861911), an oral BACE1 inhibitor, in early Alzheimer's disease spectrum patients: a randomized, double-blind, placebo-controlled study and a two-period extension study. Alzheimers Res Ther. 2020 May 14;12(1):58. doi: 10.1186/s13195-020-00614-5.

Reference Type: DERIVED

PMID: 32410694 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

54861911ALZ2004

Identifier Type: OTHER

Identifier Source: secondary_id

2014-004274-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR106978

Identifier Type: -

Identifier Source: org_study_id