Clinical Effectiveness of 10 cm^2 Rivastigmine Patch in Patients With Alzheimer's Disease (ADEPT)
2012年4月10日 更新者：Novartis
A 24-week, Multi-center, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm^2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (MMSE10-26)
This study evaluated the safety and efficacy of 10 cm^2 rivastigmine patch in patients with Alzheimer Disease (MMSE 10-26).
The primary objective was the percentage of patients who stayed on the target size of 10 cm^2 for at least 8 weeks.
This proportion was then compared to historical data of the percentage of patients who could reach a rivastigmine capsule target dose of 12 mg and stay on it at least 8 weeks.
調査の概要
研究の種類
介入
入学 (実際)
208
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。
研究場所
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Munich、ドイツ
- Novartis Investigative Site
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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
50年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Males, and females not of child-bearing potential (surgically sterile or at least one year postmenopausal), of at least 50 years of age
- Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria
- MMSE (Mini-Mental State Examination) score of > 10 and < 26
- Patients initiating therapy for the first time with a cholinesterase inhibitor (patients prescribed both rivastigmine and memantine are allowed)
- Patients who failed to benefit from previous cholinesterase inhibitor treatment
Exclusion Criteria:
- Patients not treated according to the product monograph for rivastigmine capsules
- patients involved in a clinical trial
- Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application)
Other protocol-defined exclusion criteria applied to the study.
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：処理
- 割り当て：非ランダム化
- 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 |
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実験的：Rivastigmine 5 and 10 cm^2 patch
For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch.
After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
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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 |
|---|---|---|
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Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Who Completed the Study
時間枠：Baseline to Week 24
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Dosages of study medication prescribed to and taken by the patient was assessed in a "Drug Administration Record" with start date, end date, dosage and reason for dose adjustment (if applicable).
Data was amended by counting the returned medication at the study visits and information by the caregiver.
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Baseline to Week 24
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Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Regardless Whether They Completed the Study
時間枠：Baseline to Week 24
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Dosages of study medication prescribed to and taken by the patient was assessed in a "Drug Administration Record" with start date, end date, dosage and reason for dose adjustment (if applicable).
Data was amended by counting the returned medication at the study visits and information by the caregiver.
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Baseline to Week 24
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Percentage of Participants Who Were Compliant to the 10 cm^2 Patch
時間枠：Baseline to Week 24
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Dosages of study medication prescribed to and taken by the patient was assessed in a "Drug Administration Record" with start date, end date, dosage and reason for dose adjustment (if applicable).
Data was amended by counting the returned medication at the study visits and information by the caregiver.
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Baseline to Week 24
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 24
時間枠：Baseline and Week 24
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The MMSE is a brief, practical screening test for cognitive dysfunction.
The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function.
A positive change score indicates improvement.
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Baseline and Week 24
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Mean Change From Baseline in the Trail-making Test Part A Score at Week 24
時間枠：Baseline to Week 24
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The Trail-making test is a neuropsychological test of visual attention and task switching.
The task requires a subject to 'connect-the-dots' of 25 consecutive numbers (1,2,3, etc.) on a sheet of paper or computer screen.
The goal of the subject is to finish the test as quickly as possible, and the time taken to complete the test is used as the primary performance metric (in seconds).
The maximum time allowed is 300 seconds.
A negative change score indicates improvement.
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Baseline to Week 24
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Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score at Week 24
時間枠：Baseline to Week 24
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The ADCS-ADL scale is composed of 23 items developed to assess a patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, as well as making judgments and decisions.
Responses for each item will be obtained from the caregiver through an interview.
The range for the total ADCS-ADL score is 0 to 78; a higher score indicates a more self-sufficient individual.
A positive change score indicates improvement.
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Baseline to Week 24
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Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician
時間枠：Baseline to Week 24
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The ADCS-CGIC is an assessment tool to make a judgment of change in a patient's condition.
Change is derived from comparing an assessment performed at baseline versus an assessment at the end of the study.
Change is categorized into 1 of 7 categories: No change; minimal, moderate, or marked improvement; or minimal, moderate, or marked decline.
Results are reported as number of patients in the indicated change category.
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Baseline to Week 24
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Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver
時間枠：Baseline t0 Week 24
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The ADCS-CGIC is an assessment tool to make a judgment of change in a patient's condition.
Change is derived from comparing an assessment performed at baseline versus an assessment at the end of the study.
Change is categorized into 1 of 7 categories: No change; minimal, moderate, or marked improvement; or minimal, moderate, or marked decline.
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Baseline t0 Week 24
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Mean Change From Baseline in the Mini-Zarit Inventory Score of Caregiver Burden at Week 24
時間枠：Baseline to Week 24
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The Mini-Zarit Inventory assesses the burden of a caregiver in caring for a patient.
The inventory is composed of 5 questions which are rated according to the following answers: 0 = never, ½ = sometimes, 1 = often.
The ratings on the 5 questions are added together resulting in a total score of 0 to 7 with a higher score indicating greater caregiver burden.
A negative change score indicates reduced burden.
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Baseline to Week 24
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スポンサー
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。
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
2007年11月1日
一次修了 (実際)
2008年11月1日
研究の完了 (実際)
2008年11月1日
試験登録日
最初に提出
2007年11月19日
QC基準を満たした最初の提出物
2007年11月19日
最初の投稿 (見積もり)
2007年11月21日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年4月16日
QC基準を満たした最後の更新が送信されました
2012年4月10日
最終確認日
2012年4月1日
詳しくは
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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