Evaluation of the Efficacy of Varenicline on Cognition, Safety, Tolerability and Pharmacokinetics in Subjects With Mild-to-Moderate Alzheimer's Disease
NCT ID: NCT00744978
Last Updated: 2011-11-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2009-07-31
2010-11-30
Brief Summary
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2. Evaluate the effects of varenicline on clinically relevant measures including attention and executive function, behavior, and clinician rated global change.
3. Evaluate the safety and tolerability of varenicline, relative to placebo, in patients with mild to moderate Alzheimer's disease
4. Evaluate the pharmacokinetics of varenicline in patients with mild to moderate Alzheimer's disease.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Varenicline
Varenicline
0.5 mg once daily for 1 week followed by 0.5 mg twice daily for 1 week followed by 1 mg twice daily for 4 weeks
Placebo
Placebo
Placebo once daily for 1 week followed by placebo twice daily for 5 weeks.
Interventions
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Varenicline
0.5 mg once daily for 1 week followed by 0.5 mg twice daily for 1 week followed by 1 mg twice daily for 4 weeks
Placebo
Placebo once daily for 1 week followed by placebo twice daily for 5 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Diagnosis or history of clinically significant cerebrovascular or cardiovascular disease
* Subjects with pulmonary disease or evidence of clinically significant pulmonary symptoms
55 Years
85 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Seongnam, Gyunggido, South Korea
Pfizer Investigational Site
Busan, , South Korea
Pfizer Investigational Site
Daegu, , South Korea
Pfizer Investigational Site
Incheon, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Suwon, , South Korea
Countries
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References
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Kim SY, Choi SH, Rollema H, Schwam EM, McRae T, Dubrava S, Jacobsen J. Phase II crossover trial of varenicline in mild-to-moderate Alzheimer's disease. Dement Geriatr Cogn Disord. 2014;37(3-4):232-45. doi: 10.1159/000355373. Epub 2013 Nov 14.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3051101
Identifier Type: -
Identifier Source: org_study_id