Alzheimer's Disease MedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852
Conditions
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants in the early Alzheimer’s disease (AD) spectrum at time of enrollment meeting all pertinent inclusion and exclusion criteria of the parent protocol, must have very recently completed their treatment in a phase 1b or phase 2 JNJ-54861911 clinical study (e.g., 54861911ALZ2002) under the parent protocol. Enrollment in the study should be completed (Day 1 double blind treatment phase) as soon as possible, but within 6 weeks, following completion of their treatment period under the parent protocol. If not defined under the parent protocol, completion of the treatment period is defined as having completed all study related procedures of the last visit of the treatment period under the parent protocol. A screening phase of up to 12 weeks may be allowed following written approval of the Sponsor - Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol - Each Participants 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 95
Exclusion criteria
Exclusion criteria: - Any condition or situation which, in the opinion of the Investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject’s participation in the study - The use of concomitant medications known to prolong the QT/QTc interval - Subject has a history of moderate or severe hepatic impairment or severe renal insufficiency unless completely resolved for more than a year. Subject 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 who have completed a Phase 1b or Phase 2 clinical trial with JNJ-54861911, who are willing to continue their assigned treatment.;Secondary Objective: To assess PK/PD affects and provide ongoing access to JNJ-54861911.;Primary end point(s): Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs);Timepoint(s) of evaluation of this end point: Day 1 up to 30 days after last dose of study drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels and Soluble Amyloid Precursor Protein (sAPP) Fragments (sAPP-alpha, sAPP-beta), Total sAPP Levels 2) Percent Change From Baseline in Plasma ABeta 1-40 Levels and sAPP Fragments (sAPP-alpha, sAPP-beta), Total sAPP Levels 3) Maximum Plasma Concentration (Cmax) of JNJ-54861911 4) Area Under the Plasma/CSF Concentration-time Curve From Time 0 to tau Hours Post Dosing (AUCtau) 5) Relationship Between Changes in CSF and Plasma ABeta Species and sAPP Fragments With Safety ; Timepoint(s) of evaluation of this end point: 1) Day 0 and Month 12 in treatment period 1; Every 24 weeks and 96 weeks in treatment period 2 up to end of treatment visit (until registration of JNJ-54861911 or any safety issue) 2) Day 0 and Month 12 in treatment period 1; Every 24 weeks and 96 weeks in treatment period 2 up to end of treatment visit (until registration of JNJ-54861911 or any safety issue) 3) Day 0 and Month 12 in treatment period 1; Every 24 weeks and 96 weeks in treatment period 2 up to end of treatment visit (until registration of JNJ-54861911 or any safety issue) 4) Day 0 and Month 12 in treatment period 1; Every 24 weeks and 96 weeks in treatment period 2 up to end of treatment visit (until registration of JNJ-54861911 or any safety issue) 5) Day 1 up to 30 days after last dose of study drug administration | — |
Countries
Belgium, France, Germany, Netherlands, Spain, Sweden
Contacts
Public ContactClinical Registry Group
Janssen Pharmaceutica N.V.
Outcome results
None listed