Evaluation of the Efficacy of Varenicline on Cognition, Safety, Tolerability and Pharmacokinetics in Subjects With Mild-to-Moderate Alzheimer's Disease

Evaluation of the Efficacy of Varenicline on Cognition, Safety, Tolerability and Pharmacokinetics in Subjects With Mild-to-Moderate Alzheimer's Disease

This study is not yet open for participant recruitment.
Verified by Pfizer, October 2008

Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00744978
Purpose

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 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.

Condition Intervention Phase
Alzheimer's Disease
Drug: Varenicline
Drug: Placebo
Phase II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Varenicline Varenicline tartrate

U.S. FDA Resources

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Safety/Efficacy Study
Official Title: A Phase 2 Multicenter, Double-Blind, Placebo-Controlled, Crossover Trial of Varenicline Tartrate (CP-526,555) in Patients With Mild to Moderate Alzheimer's Disease

Further study details as provided by Pfizer:

Primary Outcome Measures:

* Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

* Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at week 3 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
* Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]
* Clinical Global Impression - Improvement [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
* Neuropsychiatric Inventory [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: Yes ]
* Computerized Test Battery for Cognition [ Time Frame: 1, 3 and 6 weeks ] [ Designated as safety issue: No ]
* Adverse events, vital signs (blood pressure, pulse rate, respiration), body weight, electrocardiogram, physical exam, laboratory tests [ Time Frame: 1, 3 and 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Varenicline: Experimental Drug: 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 Comparator Drug: Placebo
Placebo once daily for 1 week followed by placebo twice daily for 5 weeks.

Eligibility
Ages Eligible for Study: 55 Years to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744978

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Sponsors and Collaborators
Pfizer

Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party: Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A3051101
First Received: August 29, 2008
Last Updated: October 16, 2008
ClinicalTrials.gov Identifier: NCT00744978
Health Authority: Korea: Food and Drug Administration

Keywords provided by Pfizer:
Efficacy, Safety, Pharmacokinetics, Alzheimer's disease

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 12, 2008