Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as JNJ-54861911
Atabecestat · 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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Atabecestat was developed for the treatment of Alzheimer disease. It is an investigational small molecule that was studied in early clinical development. It is not an approved therapy, and no Phase 1 trial of Atabecestat is currently active.
Atabecestat targets BACE1, also known as beta-secretase 1. It acts as a BACE1 inhibitor, a class of small molecules designed to interfere with the enzyme's activity. BACE1 is involved in the production of amyloid beta peptides in the brain.
Atabecestat was developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The compound is also identified by the research code JNJ-54861911 and the ChEMBL identifier CHEMBL3916243.
Atabecestat is in Phase 1 development. It is an investigational drug and is not FDA approved. The only recorded trial is an early Phase 1 study that has been completed, and no active trials are ongoing.
Atabecestat was studied in one completed early Phase 1 trial, NCT03587376, titled Characterization of T-Cell Response in Participants Previously Treated With JNJ-54861911 (Atabecestat). The trial enrolled 9 participants with Alzheimer disease across Belgium, France, Germany, Spain, and Sweden.
Yes, Atabecestat is the same compound as JNJ-54861911. JNJ-54861911 is the research code used by Johnson & Johnson for this BACE1 inhibitor. Both names refer to the same investigational small molecule studied in Alzheimer disease.