Status:
COMPLETED
Evaluation of the Efficacy of Varenicline on Cognition, Safety, Tolerability and Pharmacokinetics in Subjects With Mild-to-Moderate Alzheimer's Disease
Lead Sponsor:
Pfizer
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
55-85 years
Phase:
PHASE2
Brief Summary
1. Assess the efficacy of varenicline, relative to placebo, on a performance based measure of cognition in patients with mild to moderate Alzheimer's disease 2. Evaluate the effects of varenicline on ...
Eligibility Criteria
Inclusion
- Males or females, age 55-85
- Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and 2) Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
- Mini-mental status exam score of 14-26 inclusive
- Rosen-Modified Hachinski Ischemia Score of \< or = 4
Exclusion
- Diagnosis or history of other dementia or neurodegenerative disorders
- Diagnosis or history of clinically significant cerebrovascular or cardiovascular disease
- Subjects with pulmonary disease or evidence of clinically significant pulmonary symptoms
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00744978
Start Date
July 1 2009
End Date
November 1 2010
Last Update
November 22 2011
Active Locations (8)
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1
Pfizer Investigational Site
Seongnam, Gyunggido, South Korea, 463-707
2
Pfizer Investigational Site
Busan, South Korea, 602-715
3
Pfizer Investigational Site
Daegu, South Korea, 700-721
4
Pfizer Investigational Site
Incheon, South Korea, 400-711