Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R33AG086944 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
This is an unblinded, non-randomized National Institute of Health (NIH) Stage I of Behavioral Intervention Development trial. The investigators will enroll 20 subjects with Parkinson disease (PD) for a series of 20 of N-of-1 trials. The investigators will use a single-arm crossover titration/reversal design ("ON" [A] vs. "OFF" [B]) with up to 4 periods. All participants will follow the sequence ABAB. Each period will last up to 10 weeks, allowing for sufficient time for up-titration and onset of drug action, and down-titration and washout. Each participant will have the option to participate in less (2-3) or more (3-4) periods depending on whether additional information is needed to make an informed decision about continuing or discontinuing the overactive bladder (OAB) antimuscarinic at the end of the study. The intervention drug will be an OAB antimuscarinic, previously prescribed to the participants by their physician. The investigators will reduce the dose of each OAB antimuscarinic by 25-50% every 1-2 weeks during the "OFF" [B] period, with the goal to completely discontinue the medication.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AB(AB) arm | Experimental | All participants will follow a single-arm AB(AB) sequence. During the initial "ON" [A] period, participants will continue their overactive bladder antimuscarinic at their maintenance dose for up to 10 weeks. This will be followed by an "OFF" [B] period of up to 10 weeks, during which the antimuscarinic will be gradually tapered by approximately 25%-50% every 1-2 weeks until the lowest effective dose or complete discontinuation is reached. A second AB sequence may be repeated, if needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Overactive bladder antimuscarinic deprescribing | Drug | During the "ON" [A] period (up to 10 weeks), the participant will continue taking their overactive bladder antimuscarinic at their maintenance dose. During the "OFF" [B] period (i.e., deprescribing), which will last up to 10 weeks, the antimuscarinic dose will be gradually tapered by 25%-50% every 1-2 weeks until the lowest effective dose or complete discontinuation is achieved. Alternative treatment with mirabegron (pharmacologic) may be initiated, as clinically indicated, if the participant experiences intolerable recurrence of overactive bladder symptoms after discontinuation of the antimuscarinic. |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of deprescribing overactive bladder antimuscarinics on cognitive function | The investigators will evaluate the effects of deprescribing overactive bladder (OAB) antimuscarinics in individuals with Parkinson disease (PD) on their cognitive function, as measured by the change in participant's cognitive function using the Montreal Cognitive Assessment (MoCA) when they are "ON" vs. "OFF" antimuscarinics. The MoCA score ranges from 0 to 30, with higher scores indicating better cognitive function and lower scores indicating greater cognitive impairment. | MoCA scores will be assessed at baseline (Visit 0) and at the completion of the study (Visit 41 or up to 46 weeks from baseline). |
| Effects of deprescribing overactive bladder antimuscarinics on autonomic symptom burden | The investigators will evaluate the effects of deprescribing overactive bladder (OAB) antimuscarinics in individuals with Parkinson disease (PD) on autonomic symptom burden, as measured by the change in participant's Scales for Outcomes in Parkinson's - autonomic (SCOPA-AUT) when they are "ON" vs. "OFF" antimuscarinics. SCOPA-AUT total score ranges from 0 to 69, with higher scores indicating greater autonomic symptom burden and worse autonomic dysfunction. | SCOPA-AUT scores will be assessed at baseline (Visit 0) and at the completion of the study (Visit 41 or up to 46 weeks after baseline). |
| Effects of deprescribing overactive bladder antimuscarinics on quality of life | The investigators will evaluate the effects of deprescribing overactive bladder (OAB) antimuscarinics in individuals with Parkinson disease (PD) on participant's quality of life (QOL), as measured by the change in participant's global impression of change using participant's QOL questionnaires when they are "ON" vs. "OFF" antimuscarinics. The baseline and end-of-study QOL questionnaires include questions about participant's current overall QOL (0=very poor, 1=poor, 2=fair, 3=good, 4=very good), current bladder-related QOL (0=very poor, 1=poor, 2=fair, 3=good, 4=very good), and current overall well-being affected by side effects of antimuscarinics (0=extremely, 1=quite a bit, 2=moderately, 3=a little, 4=not at all, 5=not applicable). The end-of-study QOL questionnaire include a question about overall state of health since the start of the study (0=very much worse, 1=minimally worse, 2=no change, 3=minimally improved, 4=very much improved). Higher scores indicate better QOL. |
| Measure | Description | Time Frame |
|---|---|---|
| Features of a feasible and pragmatic protocol for deprescribing N-of-1 trials | Feasibility and pragmatic features of a deprescribing N-of-1 trial protocol for older adults with Parkinson disease (PD) receiving chronic overactive bladder (OAB) antimuscarinics in a neurology specialty center will be evaluated using measures including, but not limited to, enrollment rate (participants enrolled/participants approached), retention rate (participants retained through study completion/participants enrolled), study adherence (participants attending 100% of scheduled visits and completing at least 90% of required assessments during the study period/participants enrolled), and time to study completion (weeks from enrollment to trial completion). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allison Willis, MD, MS | Contact | 215-823-5800 | Allison.Willis2@va.gov | |
| Thanh Phuong Pham Nguyen, PharmD, MBA, MSCE | Contact | 215-823-5800 | Thanhphuong.Phamnguyen@va.gov |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corporal Michael J. Crescenz VA Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25621434 | Background | Gray SL, Anderson ML, Dublin S, Hanlon JT, Hubbard R, Walker R, Yu O, Crane PK, Larson EB. Cumulative use of strong anticholinergics and incident dementia: a prospective cohort study. JAMA Intern Med. 2015 Mar;175(3):401-7. doi: 10.1001/jamainternmed.2014.7663. | |
| 37713748 | Background | Abraham DS, Pham Nguyen TP, Newcomb CW, Gray SL, Hennessy S, Leonard CE, Liu Q, Weintraub D, Willis AW. Comparative safety of antimuscarinics versus mirabegron for overactive bladder in Parkinson disease. Parkinsonism Relat Disord. 2023 Oct;115:105822. doi: 10.1016/j.parkreldis.2023.105822. Epub 2023 Sep 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
All participants will follow the AB(AB) sequence.
Not provided
Not provided
Not provided
Not provided
|
| QOL will be assessed at will be made at baseline (visit 0) and at the completion of the study (Visit 41 or up to 46 weeks from baseline). |
| These elements will be estimated at the conclusion of the study, once all participants have completed study participation (after Visit 41 or after week 46 from baseline). |
| Associations between participant and health system characteristics and attitudes toward deprescribing (i.e., satisfaction with current medications) | The investigators will explore the association between participant and health system characteristics and their satisfaction with current medication as measured by the Revised Patient Attitudes toward Deprescribing (rPATD) Questionnaire, when possible. The rPATD reports attitudes across 4 domains (burden, appropriateness, concerns about stopping, and involvement), and 2 global questions evaluating satisfaction with current medications and willingness to stop medication(s) if recommended by a physician. Scores range from 0-4, and higher scores indicate stronger agreement with the construct (e.g., greater perceived medication burden, stronger belief in medication inappropriateness, greater concerns about stopping, or greater desire for involvement, greater satisfaction with current medications and greater willingness to stop). The investigators will use participant's answer on satisfaction with current medications for this association. | At baseline (Visit 0) and at the completion of the study (Visit 41 or up to week 46 after baseline) |
| Associations between participant and health system characteristics and attitudes toward deprescribing (i.e., willingness to deprescribe) | The investigators will explore the association between participant and health system characteristics and their willingness to deprescribe as measured by the Revised Patient Attitudes toward Deprescribing (rPATD) Questionnaire, when possible. The rPATD reports attitudes across 4 domains (burden, appropriateness, concerns about stopping, and involvement), and 2 global questions evaluating satisfaction with current medications and willingness to stop medication(s) if recommended by a physician. Scores range from 0-4, and higher scores indicate stronger agreement with the construct (e.g., greater perceived medication burden, stronger belief in medication inappropriateness, greater concerns about stopping, or greater desire for involvement, greater satisfaction with current medications and greater willingness to stop). The investigators will use participant's answer on willingness to deprescribe for this association. | At baseline (Visit 0) and at the completion of the study (Visit 41 or up to week 46 after baseline) |
| 32255485 | Background | Abraham DS, Pham Nguyen TP, Hennessy S, Weintraub D, Gray SL, Xie D, Willis AW. Frequency of and risk factors for potentially inappropriate medication use in Parkinson's disease. Age Ageing. 2020 Aug 24;49(5):786-792. doi: 10.1093/ageing/afaa033. |
| 35705532 | Background | Goyal P, Safford MM, Hilmer SN, Steinman MA, Matlock DD, Maurer MS, Lachs MS, Kronish IM. N-of-1 trials to facilitate evidence-based deprescribing: Rationale and case study. Br J Clin Pharmacol. 2022 Oct;88(10):4460-4473. doi: 10.1111/bcp.15442. Epub 2022 Jul 13. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |