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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01066481 |
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Date of registration:
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09/02/2010 |
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Primary sponsor: |
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Public title:
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A Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease
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Scientific title:
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A Phase 2, Multi-Center, Double-Blinded, Placebo-Controlled Safety And Efficacy Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT01066481 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Mild-to-Moderate Alzheimer's disease
- MMSE score 10-24 inclusive
Exclusion Criteria:
- Administration of anti-dementia drugs including cholinesterase-inhibitors or NMDA
receptor antagonists within 90 days
- Complication of other causes of dementia
Age minimum:
50 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alzheimer's Disease
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Dementia
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Dimebon
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Investigational Drug
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Intervention(s)
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Drug: PF-01913539 5 mg
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Drug: Placebo
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Primary Outcome(s)
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Distribution of Clinician's Interview-Based Impression of Change plus Caregiver (CIBIC-plus) Input
[Time Frame: 26 weeks]
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Mean change in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) score from baseline.
[Time Frame: 26 weeks]
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Secondary Outcome(s)
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Adverse events, physical examination, vital signs (blood pressure, temperature, and heart rate), 12-lead ECG, and laboratory tests (hematology, blood chemistry and urinalysis).
[Time Frame: 12, 26 weeks]
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Mean change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADAS-ADL) score from baseline.
[Time Frame: 12, 26 weeks]
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Mean change in each item of Resource Utilization In Dementia(RUD) Lite from baseline.
[Time Frame: 12, 26 weeks]
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Mean change in Mini-Mental State Examination (MMSE) score from baseline.
[Time Frame: 6, 12, 18, 26 weeks]
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Mean change in Neuropsychiatric Inventory (NPI) score from baseline.
[Time Frame: 12, 26 weeks]
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Population PK parameters (CL/F, V/F, etc.)
[Time Frame: 26 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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