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| ID | Type | Description | Link |
|---|---|---|---|
| 54861911ALZ1008 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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The purpose of this study is to determine the safety, tolerability and effect of JNJ-54861911 on level of amyloid-beta in Cerebrospinal Fluid (CSF) and plasma following 4 weeks of treatment in Japanese participants asymptomatic at risk for Alzheimer Dementia (ARAD) at the intended target dose range.
This is a multi-center (when more than one hospital or medical school team work on a medical research study), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (the experimental treatment or procedure is compared to an inactive substance), randomized (study medication assigned by chance), multiple dose, Proof of Mechanism (POM) study in Japanese participants ARAD. All eligible participants will be randomly assigned to 1 of 3 treatment groups (that is, placebo, JNJ-54861911 10 milligram [mg] or JNJ-54861911 50 mg once daily regimen). This study will consist of Screening Phase (8-week), Double blind Treatment Phase (4-week), and Follow-up Phase (2-week). The maximum study duration for a participant will be 14 weeks. Participant's safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | Placebo matching to JNJ-54861911 tablet orally once daily for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-54861911, 10 mg | Drug | JNJ-54861911, 10 mg (2*5 mg tablet) orally once daily for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Levels of Amyloid (A)-beta1-40 in Cerebrospinal Fluid (CSF) After Treatment at the Intended Target Dose Range | Up to 4 weeks | |
| Levels of A-beta1-40 in Plasma After Treatment at the Intended Target Dose Range | Up to 4 weeks | |
| Maximum Observed Plasma Concentration (Cmax) of JNJ 54861911 | The Cmax is the maximum observed plasma concentration. | Up to 4 weeks |
| Minimum Observed Plasma Concentration (Cmin) of JNJ 54861911 | The Cmin is the minimum observed plasma concentration. | Up to 4 weeks |
| Time to Reach Maximum Observed Concentration (Tmax) of JNJ 54861911 | The Tmax is time to reach the maximum observed plasma concentration. | Up to 4 weeks |
| Area Under the Curve From Time Zero to end of Dosing Interval (AUCtau) | 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. | Up to 4 weeks |
| Cerebrospinal Fluid Exposure of JNJ-54861911 | Up to 4 weeks | |
| The Number of Participants who Experienced Adverse Events as a Measure of Safety and Tolerability of JNJ-54861911 After Multiple-Dose Administration in the Anticipated Target Dose Range |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of A-beta Fragments (A-beta1-37, A-beta1-38, and A-beta1-42) in CSF After Treatment at the Intended Target Dose Range | Up to 4 weeks | |
| Levels of A-beta Fragments (A-beta1-37, A-beta1-38, and A-beta1-42) in Plasma After Treatment at the Intended Target Dose Range |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30134967 | Derived | Timmers M, Streffer JR, Russu A, Tominaga Y, Shimizu H, Shiraishi A, Tatikola K, Smekens P, Borjesson-Hanson A, Andreasen N, Matias-Guiu J, Baquero M, Boada M, Tesseur I, Tritsmans L, Van Nueten L, Engelborghs S. Pharmacodynamics of atabecestat (JNJ-54861911), an oral BACE1 inhibitor in patients with early Alzheimer's disease: randomized, double-blind, placebo-controlled study. Alzheimers Res Ther. 2018 Aug 23;10(1):85. doi: 10.1186/s13195-018-0415-6. |
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| JNJ-54861911, 50 mg | Drug | JNJ-54861911, 50 mg (2*25 mg tablet) orally once daily for 4 weeks. |
|
| Placebo | Drug | Placebo matching to JNJ-54861911 tablet orally once daily for 4 weeks. |
|
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.
| Up to 4 weeks |
| Up to 4 weeks |
| Levels of Soluble Amyloid Precursor Protein (APP) Fragments in CSF (sAPP-alpha, sAPP-beta, totalAPP) After Treatment at the Intended Target Dose Range | Up to 4 weeks |
| Compare the Relationship of A-beta1-40 Levels in Plasma and CSF After Treatment at the Intended Dose Range | Up to 4 weeks |
| Tokyo |
| Japan |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000634126 | atabecestat |
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