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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00744978
First received: August 29, 2008
Last updated: October 12, 2011
Last verified: October 2011

August 29, 2008
October 12, 2011
July 2009
November 2010   (final data collection date for primary outcome measure)
Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
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.
Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00744978 on ClinicalTrials.gov Archive Site
  • Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 3 [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    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.
  • Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3 [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    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.
  • Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.
  • Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.
  • Neuropsychiatric Inventory (NPI) Total Score at Week 3 [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    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.
  • Neuropsychiatric Inventory (NPI) Total Score at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.
  • Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    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.
  • Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 3 [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    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.
  • Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.
  • Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    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.
  • Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 3 [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    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.
  • Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.
  • Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    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.
  • Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 3 [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    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.
  • Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.
  • Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    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.
  • Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 3 [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    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.
  • Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.
  • Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    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.
  • Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 3 [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    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.
  • Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.
  • 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 ]
Not Provided
Not Provided
 
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
  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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • 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
    Other Name: Chantix, Champix
  • Drug: Placebo
    Placebo once daily for 1 week followed by placebo twice daily for 5 weeks.
  • Experimental: Varenicline
    Intervention: Drug: Varenicline
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
55 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00744978
A3051101
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP