A Double-blind, Placebo-Controlled, Randomized, 4-Week, Multiple-Dose, Proof-of-Mechanism Study in Subjects With Prodromal Alzheimer's Disease Investigating the Effects of JNJ-54861911 on Aβ Processing in CSF and Plasma

NCT01978548 Phase 1 COMPLETED

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JNJ-54861911 in patients with prodromal Alzheimer's disease (pAD).

Details

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 1
Status	COMPLETED
Enrolment	45
Start date	2013-12
Completion	2015-04

Conditions

• Alzheimer Disease

Interventions

• JNJ-54861911 10 mg
• JNJ-54861911 50 mg
• Placebo

Primary outcomes

• Levels of amyloid beta 1-40 in cerebrospinal (CSF) after treatment at the intended target dose range — Up to 4 weeks
• Levels of amyloid beta 1-40 in plasma after treatment at the intended target dose range — Up to 4 weeks
• Maximum observed plasma concentration (Cmax) of JNJ-54861911 — Up to 4 weeks
  Cmax is the observed maximum plasma concentration of study drug, taken directly from the plasma concentration-time profile
• Time to reach maximum observed plasma concentration of JNJ-54861911 — Up to 4 weeks
  Time when Cmax is observed, taken directly from the plasma concentration-time profile
• Area under the plasma concentration time curve (AUC) from 0 to t hours of JNJ-54861911 — Up to 4 weeks
  Area under the plasma concentration-time curve from 0 to t hours post dosing (time t is the dosing interval)
• Half-life of JNJ-54861911 — Up to 4 weeks
  Elimination half-life associated with the terminal slope of the semi-logarithmic drug concentration-time curve, calculated as 0.693/terminal slope

Countries

Belgium, Netherlands, Spain, Sweden