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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8931-010 | Other Identifier | Schering-Plough |
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This study will assess the safety and pharmacodynamics of three different doses of MK-8931, a ß-secretase inhibitor, in participants with mild to moderate Alzheimer's Disease (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: MK-8931 12 mg | Experimental | Participants receiving 12 mg MK-8931 for 7 days |
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| Treatment B: MK-8931 40 mg | Experimental | Participants receiving MK-8931 40 mg for 7 days |
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| Treatment C: Placebo matching MK-8931 12 mg or 40 mg | Placebo Comparator | Participants receiving placebo matching MK-8931 12 mg or 40 mg for 7 days |
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| Treatment D: MK-8931 60 mg | Experimental | Participant receiving MK-8931 60 mg for 7 days |
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| Treatment E: Placebo matching MK-8931 60 mg | Placebo Comparator | Participants receiving placebo matching MK-8931 60 mg for 7 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8931 | Drug | MK-8931, capsules, at a dose of 12 or 40 mg, orally, once per day for 7 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean population Inhibitory Concentration for 50% Effect (IC50) in cerebral spinal fluid (CSF) ß-amyloid peptide 40 (Aß40) | Hour 0 (predose) to 36 hours post-dose on Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CSF Aß40 concentration determined by time-weighted average from 0 to 24 hours (TWA0-24) | Baseline, and assessment over 24 hours post Day 7 dose | |
| Change in CSF soluble amyloid precursor protein ß (sAPPß ) concentration determined by TWA0-24 | Baseline, and assessment over 24 hours post Day 7 dose |
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Inclusion criteria:
Exclusion criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27807285 | Derived | Kennedy ME, Stamford AW, Chen X, Cox K, Cumming JN, Dockendorf MF, Egan M, Ereshefsky L, Hodgson RA, Hyde LA, Jhee S, Kleijn HJ, Kuvelkar R, Li W, Mattson BA, Mei H, Palcza J, Scott JD, Tanen M, Troyer MD, Tseng JL, Stone JA, Parker EM, Forman MS. The BACE1 inhibitor verubecestat (MK-8931) reduces CNS beta-amyloid in animal models and in Alzheimer's disease patients. Sci Transl Med. 2016 Nov 2;8(363):363ra150. doi: 10.1126/scitranslmed.aad9704. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000613570 | verubecestat |
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| Placebo | Drug | Placebo capsules, orally, once per day for 7 days |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |