Clinical trial NCT00744978: Evaluation of the Efficacy of Varenicline on Cognition, Safety, Tolerability and Pharmacokinetics in Subjects With Mild-to-Moderate Alzheimer's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Efficacy
Safety
Pharmacokinetics
Alzheimer's disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-01
Enrollment: 66
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 6
timeFrame: Week 6
Secondary outcomes:
measure: Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 3
timeFrame: Week 3
measure: Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3
timeFrame: Week 3
measure: Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 6
timeFrame: Week 6
measure: Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 6
timeFrame: Week 6
measure: Neuropsychiatric Inventory (NPI) Total Score at Week 3
timeFrame: Week 3
measure: Neuropsychiatric Inventory (NPI) Total Score at Week 6
timeFrame: Week 6
measure: Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 1
timeFrame: Week 1
measure: Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 3
timeFrame: Week 3
measure: Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 6
timeFrame: Week 6
measure: Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 1
timeFrame: Week 1
measure: Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 3
timeFrame: Week 3
measure: Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 6
timeFrame: Week 6
measure: Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 1
timeFrame: Week 1
measure: Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 3
timeFrame: Week 3
measure: Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 6
timeFrame: Week 6
measure: Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 1
timeFrame: Week 1
measure: Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 3
timeFrame: Week 3
measure: Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 6
timeFrame: Week 6
measure: Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 1
timeFrame: Week 1
measure: Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 3
timeFrame: Week 3
measure: Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 6
timeFrame: Week 6
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyunggido
city: Busan
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Incheon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Suwon
country: Korea, Republic of
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.