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A Study to Compare Two Medications With an Inactive Medication and Look at the Effect on a Person's Mental Ability (SENIOR)

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ClinicalTrials.gov Identifier: NCT01126424
Recruitment Status : Completed
First Posted : May 19, 2010
Results First Posted : October 15, 2012
Last Update Posted : October 15, 2012
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition: Cognition
Interventions: Drug: Solifenacin
Drug: Oxybutynin
Drug: Placebo

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Solifenacin / Oxybutynin / Placebo Participants received 21 days of each treatment in the following order: 5 mg solifenacin, 10 mg oxybutynin, placebo. There was a 21-day washout period between each treatment period.
Solifenacin / Placebo / Oxybutynin Participants received 21 days of each treatment in the following order: 5 mg solifenacin, placebo, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
Oxybutynin / Placebo / Solifenacin Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, placebo, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
Oxybutynin / Solifenacin / Placebo Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, 5 mg solifenacin, placebo. There was a 21-day washout period between each treatment period.
Placebo / Solifenacin / Oxybutynin Participants received 21 days of each treatment in the following order: placebo, 5 mg solifenacin, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
Placebo / Oxybutynin / Solifenacin Participants received 21 days of each treatment in the following order: placebo, 10 mg oxybutynin, 5 mg solifenacin. There was a 21-day washout period between each treatment period.

Participant Flow:   Overall Study
    Solifenacin / Oxybutynin / Placebo   Solifenacin / Placebo / Oxybutynin   Oxybutynin / Placebo / Solifenacin   Oxybutynin / Solifenacin / Placebo   Placebo / Solifenacin / Oxybutynin   Placebo / Oxybutynin / Solifenacin
STARTED   3 [1]   4 [1]   5 [1]   6 [1]   4 [1]   4 [1] 
Safety Analysis Subset 1 (SAF 1)   3 [2]   4 [2]   4 [2]   4 [2]   4 [2]   4 [2] 
COMPLETED   3   4   4   3   2   4 
NOT COMPLETED   0   0   1   3   2   0 
Adverse Event                0                0                0                0                1                0 
Withdrawal by Subject                0                0                1                3                1                0 
[1] All randomized patients who took at least 1 dose of study drug
[2] Took at least 1 dose of study drug and completed cognitive function tests for at least 2 treatments.



  Baseline Characteristics

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
Solifenacin / Oxybutynin / Placebo Participants received 21 days of each treatment in the following order: 5 mg solifenacin, 10 mg oxybutynin, placebo. There was a 21-day washout period between each treatment period.
Solifenacin / Placebo / Oxybutynin Participants received 21 days of each treatment in the following order: 5 mg solifenacin, placebo, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
Oxybutynin / Placebo / Solifenacin Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, placebo, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
Oxybutynin / Solifenacin / Placebo Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, 5 mg solifenacin, placebo. There was a 21-day washout period between each treatment period.
Placebo / Solifenacin / Oxybutynin Participants received 21 days of each treatment in the following order: placebo, 5 mg solifenacin, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
Placebo / Oxybutynin / Solifenacin Participants received 21 days of each treatment in the following order: placebo, 10 mg oxybutynin, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
Total Total of all reporting groups

Baseline Measures
   Solifenacin / Oxybutynin / Placebo   Solifenacin / Placebo / Oxybutynin   Oxybutynin / Placebo / Solifenacin   Oxybutynin / Solifenacin / Placebo   Placebo / Solifenacin / Oxybutynin   Placebo / Oxybutynin / Solifenacin   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   4   5   6   4   4   26 
Age 
[Units: Years]
Mean (Standard Deviation)
 79.7  (3.8)   78.8  (2.5)   80.2  (4.4)   76.7  (2.0)   79.3  (2.9)   79.0  (4.1)   78.8  (3.2) 
Gender 
[Units: Participants]
             
Female   1   1   3   3   2   2   12 
Male   2   3   2   3   2   2   14 
Race/Ethnicity, Customized 
[Units: Participants]
             
White   3   4   5   6   4   4   26 
Stockholm criteria for mild cognitive impairment [1] 
[Units: Participants]
             
Yes   3   4   5   6   4   4   26 
No   0   0   0   0   0   0   0 
[1]

The Stockholm criteria for identification of mild cognitive impairment are:

  • Cognitive complaints from patients or families
  • Reporting of decline in cognitive functioning relative to previous abilities during the past year by patient or informant
  • Cognitive disorders as evidenced by clinical evaluation (impairment in memory or in another cognitive domain)
  • Absence of major repercussions on daily life (the patient may report difficulties in day-to-day activities)
  • Absence of dementia
Total Mini-Mental State Examination (MMSE) Score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 27.7  (0.58)   28.3  (1.26)   28.0  (1.00)   27.3  (1.75)   26.5  (1.00)   27.3  (2.06)   27.5  (1.39) 
[1] The mini-mental state examination (MMSE) provides measures of orientation, registration (immediate memory), short-term memory (but not long-term memory) and language functioning. The investigator reads a series of questions aloud clearly and slowly to the patient and scores each incorrect answer with “0” and each correct answer with “1”, for a maximum score of 30.
Total Geriatric Depression Scale (GDS) Score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 1.0  (1.73)   1.0  (0.82)   1.4  (1.67)   1.0  (0.63)   1.3  (0.96)   1.8  (1.26)   1.2  (1.11) 
[1] The short-form geriatric depression scale (GDS) was developed as a basic screening measure for depression in older adults. It is a 15-point questionnaire in which the patient is required to answer ‘yes’ or ‘no’. The GDS responses were translated into a binary scale on which “1” was indicative of depression and “0” was not; the total score ranges from 0 to 15. A score of > 5 points is considered suggestive of depression. Scores of > 10 points are almost always indicative of depression.


  Outcome Measures

1.  Primary:   Change From Baseline in Cognitive Function Composite Score - Power of Attention   [ Time Frame: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose. ]

2.  Primary:   Change From Baseline in Cognitive Function Composite Score – Continuity of Attention   [ Time Frame: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose. ]

3.  Primary:   Change From Baseline in Cognitive Function Composite Score - Quality of Working Memory   [ Time Frame: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose. ]

4.  Primary:   Change From Baseline in Cognitive Function Composite Score - Quality of Episodic Secondary Memory   [ Time Frame: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose. ]

5.  Primary:   Change From Baseline in Cognitive Function Composite Score - Speed of Memory   [ Time Frame: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose. ]

6.  Secondary:   Change From Baseline in Postural Stability Test   [ Time Frame: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose. ]


  Serious Adverse Events


  Other Adverse Events


  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
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.


  More Information

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.


Results Point of Contact:  
Name/Title: Associate Medical Director Urology
Organization: Astellas Pharma Europe Ltd.
e-mail: clinicaltrials@us.astellas.com


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01126424     History of Changes
Other Study ID Numbers: 905-EC-008
2008-005966-29 ( EudraCT Number )
First Submitted: April 29, 2010
First Posted: May 19, 2010
Results First Submitted: July 5, 2012
Results First Posted: October 15, 2012
Last Update Posted: October 15, 2012