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COMPLETEDPHASE2

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

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

NCT00744978•Pfizer

View on ClinicalTrials.gov

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 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.

Eligibility

Age

55 - 85 years

Sex

ALL

Healthy Volunteers

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

Locations (8)

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

Key Dates

Start Date

July 1, 2009

Primary Completion Date

November 1, 2010

Completion Date

November 1, 2010

Last Updated

November 22, 2011

Enrollment

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

Varenicline

DRUG

Placebo

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 22, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

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