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Pilot Deprescribing of Antimuscarinic Overactive Bladder Medications in Parkinson Disease

31 de mayo de 2026 actualizado por: Allison Willis, Corporal Michael J. Crescenz VA Medical Center

Evaluating the Effect of Deprescribing Antimuscarinic Overactive Bladder Medications on Cognitive Function and Quality of Life of Individuals With Parkinson Disease: A Pharmacist-led Series of N-of-1 Trials

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

20

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Allison Willis, MD, MS
  • Número de teléfono: 215-823-5800
  • Correo electrónico: allison.willis2@va.gov

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Corporal Michael J. Crescenz VA Medical Center
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Allison Willis, MD, MS
        • Sub-Investigador:
          • Thanh Phuong Pham Nguyen, PharmD, MBA, MSCE

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. 60+ years old at time of enrollment
  2. Have a diagnosis of Parkinson disease (PD) made by a movement disorders specialist
  3. Life expectancy of at least six months
  4. Are on an antimuscarinic for overactive bladder (OAB) symptoms (without concurrent use of a beta-3 agonist) for at least 3 months
  5. Are able to provide informed consent
  6. Are able to complete online surveys/questionnaires
  7. Are able to receive telephone calls and Zoom calls/telehealth meeting

Exclusion Criteria:

  1. Have untreated or uncontrolled hypertension (blood pressure [BP] ≥180/110 mmHg),
  2. Have active urinary tract infection (UTI) or chronic/recurrent UTI (≥2 UTIs in six months or ≥3 in one year)
  3. Have moderate or severe hepatic impairment (Child-Pugh Score Class B or C)
  4. Have severe renal impairment (Estimated Glomerular Filtration Rate [eGFR] <30 mL/min/1.72 m2) or end-stage renal disease (on dialysis or renal replacement therapy)
  5. Have prior history of hypersensitivity or intolerance to mirabegron or vibegron
  6. Have existing cognitive impairment (Montreal Cognitive Assessment [MoCA] score <22/30) or psychiatric disorder that preclude informed consent
  7. Have any other condition that, in Principal Investigator (PI) and Co-PI's opinion, makes the individual unsuitable for study participation
  8. On non-oral form of OAB antimuscarinics, the oral solution formulation of oxybutynin chloride or the oral suspension formulation of solifenacin succinate (due to complicated tapering process)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: AB(AB) arm
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.
Droga: Overactive bladder antimuscarinic deprescribing
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Effects of deprescribing overactive bladder antimuscarinics on cognitive function
Periodo de tiempo: 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).
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
Periodo de tiempo: 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).
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
Periodo de tiempo: 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).
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.
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).

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Features of a feasible and pragmatic protocol for deprescribing N-of-1 trials
Periodo de tiempo: 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).
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).
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)
Periodo de tiempo: At baseline (Visit 0) and at the completion of the study (Visit 41 or up to week 46 after baseline)
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)
Periodo de tiempo: At baseline (Visit 0) and at the completion of the study (Visit 41 or up to week 46 after baseline)
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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Corporal Michael J. Crescenz VA Medical Center

Colaboradores

National Institute on Aging (NIA)

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de abril de 2027

Finalización del estudio (Estimado)

1 de abril de 2027

Fechas de registro del estudio

Enviado por primera vez

8 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

31 de mayo de 2026

Publicado por primera vez (Actual)

4 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

31 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1889946-4
  • R33AG086944 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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