Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Atabecestat
JNJ-54861911 · 4 trials · 2 indications
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
The Cmax is the maximum observed plasma concentration.
The Cmin is the minimum observed plasma concentration.
The Tmax is time to reach the maximum observed plasma concentration.
The AUCtau is a measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption.
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Cmax is the observed maximum plasma concentration of study drug, taken directly from the plasma concentration-time profile
Time when Cmax is observed, taken directly from the plasma concentration-time profile
Area under the plasma concentration-time curve from 0 to t hours post dosing (time t is the dosing interval)
Elimination half-life associated with the terminal slope of the semi-logarithmic drug concentration-time curve, calculated as 0.693/terminal slope
Number of Participants with Atabecestat-Specific T-cell Mediated Inflammatory Immune Response (via cluster of differentiation \[CD\] 4+ T-cells and CD8+ T-cells) will be determined.
| Arm | Type | Description |
|---|---|---|
| Treatment Group 1 | EXPERIMENTAL | Participants will self-administer JNJ-54861911, two tablets of 5 milligram (mg) each for a total of 10 mg, orally, once daily, from Day 1 until Month 6. |
| Treatment Group 2 | EXPERIMENTAL | Participants will self-administer JNJ-54861911, two tablets of 25 mg each for a total of 50 mg, orally, once daily, from Day 1 until Month 6. |
| Placebo | PLACEBO_COMPARATOR | Placebo matched to JNJ-54861911, orally, once daily, from Day 1 until Month 6. |
| JNJ-54861911, 10 mg | EXPERIMENTAL | JNJ-54861911, 10 milligram (mg) (2\*5 mg tablet) orally once daily for 4 weeks. |
| JNJ-54861911, 50 mg | EXPERIMENTAL | JNJ-54861911, 50 mg (2\*25 mg tablet) orally once daily for 4 weeks. |
| JNJ-54861911 10 mg | EXPERIMENTAL | From Day 1 to Day 28 inclusive, patients will self-administer once daily study drug (JNJ-54861911 or placebo) with a glass of non-carbonated water (approximately 200 mL). |
| JNJ-54861911 50 mg | EXPERIMENTAL | - |
| Participants with Elevated Liver Enzymes | EXPERIMENTAL | Blood samples will be collected on Day 1 from participants previously treated with atabecestat and who had elevated liver enzymes while on atabecestat. |
| Participants Without Elevated Liver Enzymes | ACTIVE_COMPARATOR | Blood samples will be collected on Day 1 from participants who completed at least 3 months of dosing with atabecestat and who did not have the elevated liver enzymes (adverse event) while on atabecestat. |
| Name | Type | Description |
|---|---|---|
| JNJ-54861911, 10 milligram (mg) | DRUG | Participants will self-administer JNJ-54861911, two tablets of 5 mg each for a total of 10 mg, orally, once daily, from Day 1 until Month 6 in treatment group 1. |
| JNJ-54861911, 50 mg | DRUG | Participants will self-administer JNJ-54861911, two tablets of 25 mg each for a total of 50 mg, orally, once daily, from Day 1 until Month 6 in treatment group 2. |
| Placebo | DRUG | Placebo matched to JNJ-54861911, orally, once daily, from Day 1 until Month 6 in placebo group. |
| JNJ-54861911, 10 mg | DRUG | JNJ-54861911, 10 mg (2\*5 mg tablet) orally once daily for 4 weeks. |
| JNJ-54861911 10 mg | DRUG | JNJ-54861911 10 mg will be administered as two 5 mg oral tablets once daily. |
| JNJ-54861911 50 mg | DRUG | JNJ-54861911 50 mg will be administered as two 25 mg oral tablets once daily. |
| Atabecestat | DRUG | Blood samples will be collected from participants previously treated with atabecestat. |
Inclusion Criteria: * Participants in the early alzheimer's disease (AD) spectrum must have a global Clinical Dementia Rating Scale( CDR) score of 0 (asymptomatic at risk for AD) to 0.5 prodromal AD (pAD) inclusive * Participants must have evidence of amyloid pathology by means of either: a) low Ce...
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JNJ-54861911 is an investigational small molecule being studied for Alzheimer disease. It was evaluated in clinical trials involving participants with early Alzheimer's disease, prodromal Alzheimer's disease, and asymptomatic individuals at risk for Alzheimer dementia. It is not an approved treatment.
JNJ-54861911 is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the clinical trials evaluating the drug in Alzheimer disease and related early stages.
JNJ-54861911 has completed Phase 2 clinical development. The Phase 2 trial, NCT02260674, was a safety and tolerability study in participants with early Alzheimer's disease. The drug is investigational and has not been approved for any indication.
JNJ-54861911 has been studied in three completed trials: NCT02360657, a Phase 1 study in Japanese participants asymptomatic at risk for Alzheimer dementia; NCT02260674, a Phase 2 safety and tolerability study in early Alzheimer's disease; and NCT01978548, a Phase 1 study in prodromal Alzheimer's disease.