Trial Outcomes & Findings for The Effect of Anticholinergics on Cognitive Function in the Elderly (NCT NCT01922115)
NCT ID: NCT01922115
Last Updated: 2017-03-22
Results Overview
Assesses short term verbal learning and memory. Subscales include immediate recall (0-36) and delayed recall (0-12). Higher values indicate better outcomes.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
59 participants
Primary outcome timeframe
Week 4
Results posted on
2017-03-22
Participant Flow
Participant milestones
| Measure |
TROSPIUM CHLORIDE
Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit.
|
PLACEBO
Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
31
|
|
Overall Study
COMPLETED
|
21
|
24
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Anticholinergics on Cognitive Function in the Elderly
Baseline characteristics by cohort
| Measure |
TROSPIUM CHLORIDE
n=28 Participants
Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit.
|
PLACEBO
n=31 Participants
Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
Placebo
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.39 years
STANDARD_DEVIATION 11.615 • n=5 Participants
|
68.71 years
STANDARD_DEVIATION 10.615 • n=7 Participants
|
68.56 years
STANDARD_DEVIATION 11.005 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7 participants
n=5 Participants
|
25 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
21 participants
n=5 Participants
|
4 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4Assesses short term verbal learning and memory. Subscales include immediate recall (0-36) and delayed recall (0-12). Higher values indicate better outcomes.
Outcome measures
| Measure |
TROSPIUM CHLORIDE
n=21 Participants
Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit.
|
PLACEBO
n=24 Participants
Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
Placebo
|
|---|---|---|
|
Hopkins Verbal Learning Test - Revised
Immediate Recall
|
22.00 units on a scale
Standard Deviation 5.51
|
24.38 units on a scale
Standard Deviation 5.96
|
|
Hopkins Verbal Learning Test - Revised
Delayed Recall
|
6.71 units on a scale
Standard Deviation 2.80
|
7.83 units on a scale
Standard Deviation 3.28
|
PRIMARY outcome
Timeframe: Week 4Assesses short term verbal learning and memory. See below for the subscale delayed recognition (0-24). Percentages of total responses correct are reported for delayed recognition, higher values indicate better outcomes.
Outcome measures
| Measure |
TROSPIUM CHLORIDE
n=21 Participants
Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit.
|
PLACEBO
n=24 Participants
Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
Placebo
|
|---|---|---|
|
Hopkins Verbal Learning Test - Revised
|
81.68 percentage of total correct
Standard Deviation 47.45
|
83.49 percentage of total correct
Standard Deviation 26.72
|
SECONDARY outcome
Timeframe: Week 4The mini-mental state examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. The range is 0-30, with higher values indicating better outcomes.
Outcome measures
| Measure |
TROSPIUM CHLORIDE
n=21 Participants
Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit.
|
PLACEBO
n=24 Participants
Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
Placebo
|
|---|---|---|
|
Mini-Mental State Examination
|
28.14 units on a scale
Standard Deviation 1.90
|
28.38 units on a scale
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: Week 4The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument was developed and validated in both continent and incontinent OAB patients, including both men and women. Total range is 19-101 and higher values indicate worse outcomes.
Outcome measures
| Measure |
TROSPIUM CHLORIDE
n=21 Participants
Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit.
|
PLACEBO
n=24 Participants
Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
Placebo
|
|---|---|---|
|
Overactive Bladder Questionnaire
|
41.45 units on a scale
Standard Deviation 18.84
|
56.04 units on a scale
Standard Deviation 20.21
|
Adverse Events
TROSPIUM CHLORIDE
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
PLACEBO
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TROSPIUM CHLORIDE
n=28 participants at risk
Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit.
|
PLACEBO
n=31 participants at risk
Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
Placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Distress
|
3.6%
1/28 • Number of events 1
|
0.00%
0/31
|
|
Vascular disorders
Blood Clot
|
3.6%
1/28 • Number of events 1
|
0.00%
0/31
|
Other adverse events
| Measure |
TROSPIUM CHLORIDE
n=28 participants at risk
Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit.
|
PLACEBO
n=31 participants at risk
Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
14.3%
4/28 • Number of events 4
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Dry Mouth
|
14.3%
4/28 • Number of events 4
|
0.00%
0/31
|
|
Psychiatric disorders
Depression
|
3.6%
1/28 • Number of events 1
|
0.00%
0/31
|
|
Renal and urinary disorders
UTI
|
3.6%
1/28 • Number of events 1
|
0.00%
0/31
|
|
General disorders
Dizziness
|
3.6%
1/28 • Number of events 1
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
3.6%
1/28 • Number of events 1
|
0.00%
0/31
|
|
Eye disorders
Dry Eyes
|
0.00%
0/28
|
3.2%
1/31 • Number of events 1
|
|
Psychiatric disorders
Mood Swings
|
0.00%
0/28
|
3.2%
1/31 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place