Trial record 1 of 1 for:    pfizer varenicline alzheimer's
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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
Results First Received: October 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: Varenicline
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Each participant was to complete a 3-week placebo run-in period then receive a treatment sequence of either varenicline followed by placebo, or placebo followed by varenicline, separated by a 3-week placebo washout period. Of 92 participants screened, 66 participants were randomized to treatment.

Reporting Groups
  Description
Varenicline Then Placebo Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks; then placebo once daily for 1 week followed by placebo BID for 5 weeks.
Placebo Then Varenicline Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks; then varenicline 0.5 mg once daily for 1 week followed by 0.5 mg BID for 1 week followed by 1 mg BID for 4 weeks.

Participant Flow for 3 periods

Period 1:   Period 1
    Varenicline Then Placebo     Placebo Then Varenicline  
STARTED     32     34  
Treated     31     33  
COMPLETED     26     29  
NOT COMPLETED     6     5  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 0                 2  
Unspecified                 0                 2  
Adverse Event                 4                 0  
Randomized but not Treated                 1                 1  

Period 2:   Placebo Washout
    Varenicline Then Placebo     Placebo Then Varenicline  
STARTED     26     29  
COMPLETED     26     29  
NOT COMPLETED     0     0  

Period 3:   Period 2
    Varenicline Then Placebo     Placebo Then Varenicline  
STARTED     26     29  
COMPLETED     26     28  
NOT COMPLETED     0     1  
Adverse Event                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Varenicline Then Placebo Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks; then placebo once daily for 1 week followed by placebo BID for 5 weeks.
Placebo Then Varenicline Placebo twice a day (BID) initiated with a 2-week titration regimen (Week 1: once a day [QD]; Week 2: BID), followed by varenicline 1 mg BID initiated with a 2-week titration regimen (Week 1: 0.5 mg QD; Week 2: 0.5 mg BID).
Total Total of all reporting groups

Baseline Measures
    Varenicline Then Placebo     Placebo Then Varenicline     Total  
Number of Participants  
[units: participants]
  32     34     66  
Age  
[units: years]
Mean ± Standard Deviation
  71.5  ± 8.7     73.9  ± 5.8     72.7  ± 7.4  
Gender  
[units: participants]
     
Female     21     21     42  
Male     11     13     24  



  Outcome Measures
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1.  Primary:   Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 6   [ Time Frame: Week 6 ]

2.  Secondary:   Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 3   [ Time Frame: Week 3 ]

3.  Secondary:   Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3   [ Time Frame: Week 3 ]

4.  Secondary:   Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 6   [ Time Frame: Week 6 ]

5.  Secondary:   Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 6   [ Time Frame: Week 6 ]

6.  Secondary:   Neuropsychiatric Inventory (NPI) Total Score at Week 3   [ Time Frame: Week 3 ]

7.  Secondary:   Neuropsychiatric Inventory (NPI) Total Score at Week 6   [ Time Frame: Week 6 ]

8.  Secondary:   Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 1   [ Time Frame: Week 1 ]

9.  Secondary:   Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 3   [ Time Frame: Week 3 ]

10.  Secondary:   Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 6   [ Time Frame: Week 6 ]

11.  Secondary:   Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 1   [ Time Frame: Week 1 ]

12.  Secondary:   Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 3   [ Time Frame: Week 3 ]

13.  Secondary:   Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 6   [ Time Frame: Week 6 ]

14.  Secondary:   Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 1   [ Time Frame: Week 1 ]

15.  Secondary:   Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 3   [ Time Frame: Week 3 ]

16.  Secondary:   Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 6   [ Time Frame: Week 6 ]

17.  Secondary:   Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 1   [ Time Frame: Week 1 ]

18.  Secondary:   Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 3   [ Time Frame: Week 3 ]

19.  Secondary:   Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 6   [ Time Frame: Week 6 ]

20.  Secondary:   Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 1   [ Time Frame: Week 1 ]

21.  Secondary:   Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 3   [ Time Frame: Week 3 ]

22.  Secondary:   Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 6   [ Time Frame: Week 6 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00744978     History of Changes
Other Study ID Numbers: A3051101
Study First Received: August 29, 2008
Results First Received: October 12, 2011
Last Updated: October 12, 2011
Health Authority: Korea: Food and Drug Administration