- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00744978
Evaluation of the Efficacy of Varenicline on Cognition, Safety, Tolerability and Pharmacokinetics in Subjects With Mild-to-Moderate Alzheimer's Disease
October 12, 2011 updated by: Pfizer
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
- Assess the efficacy of varenicline, relative to placebo, on a performance based measure of cognition in patients with mild to moderate Alzheimer's disease
- Evaluate the effects of varenicline on clinically relevant measures including attention and executive function, behavior, and clinician rated global change.
- Evaluate the safety and tolerability of varenicline, relative to placebo, in patients with mild to moderate Alzheimer's disease
- Evaluate the pharmacokinetics of varenicline in patients with mild to moderate Alzheimer's disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Busan, Korea, Republic of, 602-715
- Pfizer Investigational Site
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Daegu, Korea, Republic of, 700-721
- Pfizer Investigational Site
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Incheon, Korea, Republic of, 400-711
- Pfizer Investigational Site
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Seoul, Korea, Republic of, 138-736
- Pfizer Investigational Site
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Seoul, Korea, Republic of, 136-705
- Pfizer Investigational Site
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Seoul, Korea, Republic of, 158-710
- Pfizer Investigational Site
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Suwon, Korea, Republic of, 443-721
- Pfizer Investigational Site
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Gyunggido
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Seongnam, Gyunggido, Korea, Republic of, 463-707
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
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Placebo once daily for 1 week followed by placebo twice daily for 5 weeks.
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EXPERIMENTAL: Varenicline
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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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 6
Time Frame: Week 6
|
12-item scale to assess severity of cognitive impairment in AD.
Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility.
Total score range from 0-75 with 75 indicating worse cognition.
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Week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 3
Time Frame: Week 3
|
12-item scale to assess severity of cognitive impairment in AD.
Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility.
Total score range from 0-75 with 75 indicating worse cognition.
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Week 3
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Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3
Time Frame: Week 3
|
11-item scale designed to assess the severity of cognitive impairments in AD subjects.
Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, and remembering test instructions.
Total score range from 0-70 with 70 indicating worse cognition.
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Week 3
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Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 6
Time Frame: Week 6
|
11-item scale designed to assess the severity of cognitive impairments in AD subjects.
Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, and remembering test instructions.
Total score range from 0-70 with 70 indicating worse cognition.
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Week 6
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Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 6
Time Frame: Week 6
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CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse).
Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
Higher score = more affected.
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Week 6
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Neuropsychiatric Inventory (NPI) Total Score at Week 3
Time Frame: Week 3
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Caregiver interview-based rating scale assessing 12 behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, appetite/eating, and sleep.
Each symptom score derived by frequency of symptoms * severity of symptoms (range 0-12).
Total score = sum of symptom scores; range: 0-144 with higher score indicating greater behavioral disturbances.
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Week 3
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Neuropsychiatric Inventory (NPI) Total Score at Week 6
Time Frame: Week 6
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Caregiver interview-based rating scale assessing 12 behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, appetite/eating, and sleep.
Each symptom score derived by frequency of symptoms * severity of symptoms (range 0-12).
Total score = sum of symptom scores; range: 0-144 with higher score indicating greater behavioral disturbances.
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Week 6
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Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 1
Time Frame: Week 1
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Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69.
Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses.
Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow.
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Week 1
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Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 3
Time Frame: Week 3
|
Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69.
Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses.
Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow.
|
Week 3
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Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 6
Time Frame: Week 6
|
Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69.
Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses.
Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow.
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Week 6
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Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 1
Time Frame: Week 1
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Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100.
Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.
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Week 1
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Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 3
Time Frame: Week 3
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Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100.
Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.
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Week 3
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Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 6
Time Frame: Week 6
|
Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100.
Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.
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Week 6
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Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 1
Time Frame: Week 1
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Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57.
Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.
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Week 1
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Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 3
Time Frame: Week 3
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Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57.
Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.
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Week 3
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Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 6
Time Frame: Week 6
|
Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57.
Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.
|
Week 6
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Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 1
Time Frame: Week 1
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Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57.
Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.
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Week 1
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Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 3
Time Frame: Week 3
|
Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57.
Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.
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Week 3
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Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 6
Time Frame: Week 6
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Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57.
Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.
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Week 6
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Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 1
Time Frame: Week 1
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Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69.
Performance variable: speed of performance; average log10 transformed reaction time for correct responses.
Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow.
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Week 1
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Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 3
Time Frame: Week 3
|
Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69.
Performance variable: speed of performance; average log10 transformed reaction time for correct responses.
Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow.
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Week 3
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Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 6
Time Frame: Week 6
|
Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69.
Performance variable: speed of performance; average log10 transformed reaction time for correct responses.
Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow.
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Week 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (ACTUAL)
November 1, 2010
Study Completion (ACTUAL)
November 1, 2010
Study Registration Dates
First Submitted
August 29, 2008
First Submitted That Met QC Criteria
August 29, 2008
First Posted (ESTIMATE)
September 1, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
November 22, 2011
Last Update Submitted That Met QC Criteria
October 12, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Alzheimer Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Nicotinic Agonists
- Cholinergic Agonists
- Varenicline
Other Study ID Numbers
- A3051101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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