Elderly, Pharmacokinetics, Overactive Bladder
Conditions
Brief summary
This study evaluates the penetration through the blood-brain-barrier of trospium chloride at plasma steady state (Day 10) in elderly subjects with overactive bladder symptoms. Trospium levels in cerebrospinal fluid (CSF) and peak and trough plasma levels will be measured. Baseline and day 10 post-dose neurocognitive testing will be compared using a reliable change index to assess if any study subject shows evidence of a clinically and statistically significant change in memory.
Interventions
Extended release, 60 mg, oral daily
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, 65-75 years of age without evidence of memory impairment * Subject has overactive bladder symptoms but otherwise healthy * Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit) * Weight within normal range * Ability to follow study instructions and likely to complete all required visits
Exclusion criteria
* Residual urine within bladder greater than 4 ounces * Moderate or severe memory impairment * Bleeding disorder * Blood-thinning agents * Concurrent overactive bladder medication * Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), galantamine or similar drugs for dementia * Chronic kidney failure * Abdominal bypass surgery for obesity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5 | Day 10, Hour 5 | Cerebral spinal fluid levels of Trospium at day 10, hour 5. Cerebral spinal fluid was collected from each patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose | Day 10 | The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). |
| Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Delayed Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose | Day 10 | The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The delayed recall score provides a measure of the patient's recent memory. The total score ranges from 0 (no memory) to 12 (best memory). |
| Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Total Score at Day 10 Post-Dose | Day 10 | The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid. |
| Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall Score at Day 10 Post-Dose | Day 10 | The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and a yes/no delayed recognition trial. The delayed recall score, derived from the delayed recall trial, provides a measure of the patient's recent memory. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Trospium Chloride Extended Release, 60 mg Trospium Chloride Extended Release, 60 mg | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Trospium Chloride Extended Release, 60 mg |
|---|---|
| Age, Continuous | 68 years |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5
Cerebral spinal fluid levels of Trospium at day 10, hour 5. Cerebral spinal fluid was collected from each patient.
Time frame: Day 10, Hour 5
Population: Intent-to-treat, which included all patients who started the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trospium Chloride Extended Release, 60 mg | Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5 | NA Picograms per milliliter (pg/mL) |
Secondary
Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall Score at Day 10 Post-Dose
The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and a yes/no delayed recognition trial. The delayed recall score, derived from the delayed recall trial, provides a measure of the patient's recent memory. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid.
Time frame: Day 10
Population: Intent-to-treat, which included all patients who started the study. Due to technical problems associated with the administration of the test, the results were invalid.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trospium Chloride Extended Release, 60 mg | Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall Score at Day 10 Post-Dose | NA Percentage of Subjects |
Secondary
Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Total Score at Day 10 Post-Dose
The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid.
Time frame: Day 10
Population: Intent-to-treat, which included all patients who started the study. Due to technical problems associated with the administration of the test, the results were invalid.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trospium Chloride Extended Release, 60 mg | Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Total Score at Day 10 Post-Dose | NA Percentage of Subjects |
Secondary
Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Delayed Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The delayed recall score provides a measure of the patient's recent memory. The total score ranges from 0 (no memory) to 12 (best memory).
Time frame: Day 10
Population: Intent-to-treat, which included all patients who started the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trospium Chloride Extended Release, 60 mg | Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Delayed Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose | 91.7 Percentage of Subjects |
Secondary
Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory).
Time frame: Day 10
Population: Intent-to-treat, which included all patients who started the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trospium Chloride Extended Release, 60 mg | Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose | 100 Percentage of Subjects |