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The purpose of this study is to demonstrate the safety and efficacy of PF-01913539 in the treatment of patients with mild-to-moderate Alzheimer's Disease. It is a 6-month study enrolling 651 patients in Japan, Hong Kong, Korea, and Republic of China. All patients completing the 6-month study will be eligible to receive PF-01913539 in an open-label extension trial (B1451031).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-01913539 5 mg three times daily | Experimental | PF-01913539 5 mg three times daily for 6 months |
|
| PF-01913539 20 mg three times daily | Experimental | PF-01913539 20 mg three times daily for 6 months |
|
| Placebo | Placebo Comparator | Placebo three times daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-01913539 5 mg | Drug | PF-01913539 5 mg three times daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) score from baseline. | 26 weeks | |
| Distribution of Clinician's Interview-Based Impression of Change plus Caregiver (CIBIC-plus) Input | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADAS-ADL) score from baseline. | 12, 26 weeks | |
| Mean change in Neuropsychiatric Inventory (NPI) score from baseline. | 12, 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D008569 | Memory Disorders |
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| ID | Term |
|---|---|
| C010119 | latrepirdine |
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| PF-01913539 5 mg | Drug | PF-01913539 5 mg three times daily for 6 months |
|
| Placebo | Drug | Placebo three times daily for 6 months |
|
| Mean change in Mini-Mental State Examination (MMSE) score from baseline. | 6, 12, 18, 26 weeks |
| Mean change in each item of Resource Utilization In Dementia(RUD) Lite from baseline. | 12, 26 weeks |
| Adverse events, physical examination, vital signs (blood pressure, temperature, and heart rate), 12-lead ECG, and laboratory tests (hematology, blood chemistry and urinalysis). | 12, 26 weeks |
| Population PK parameters (CL/F, V/F, etc.) | 26 weeks |
| D019965 |
| Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |