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Pilot Deprescribing of Antimuscarinic Overactive Bladder Medications in Parkinson Disease

2026年5月31日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

20

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アメリカ
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19104
        • Corporal Michael J. Crescenz VA Medical Center
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Allison Willis, MD, MS
        • 副調査官：
          • Thanh Phuong Pham Nguyen, PharmD, MBA, MSCE

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：他の
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Effects of deprescribing overactive bladder antimuscarinics on cognitive function
時間枠：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
時間枠：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
時間枠：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).

二次結果の測定

結果測定
メジャーの説明
時間枠
Features of a feasible and pragmatic protocol for deprescribing N-of-1 trials
時間枠：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)
時間枠：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)
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Corporal Michael J. Crescenz VA Medical Center

協力者

National Institute on Aging (NIA)

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2027年4月1日

研究の完了 (推定)

2027年4月1日

試験登録日

最初に提出

2026年5月8日

QC基準を満たした最初の提出物

2026年5月31日

最初の投稿 (実際)

2026年6月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月4日

QC基準を満たした最後の更新が送信されました

2026年5月31日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 1889946-4
  • R33AG086944 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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