Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: Health Outcome
Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial: Further Study, Health Outcome
This study is a retrospective review of the data collected in a previously completed randomized, controlled trial (RCT) entitled "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" (NCT00120874). As part of the previously completed RCT, participants with Alzheimer's Disease (AD) were randomly placed into one of two groups: memantine, or memantine plus an individualized management program consisting of home visits, educational sessions for caregivers, and a caregiver support group. Participants received the study intervention for 28 weeks; study follow-up lasted for 52 weeks.
The collected data from the existing study books from the 28 week treatment portion of the RCT will be carefully examined with respect to each of the research questions for the present retrospective study.
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
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New York
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New York、New York、アメリカ、10016
- New York University School of Medicine
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Previously participated in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：ケースコントロール
- 時間の展望：回顧
コホートと介入
グループ/コホート |
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Memantine Alone
10 subjects who previously participated in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study will be enrolled in this cohort.
These subjects received memantine for a period of 28 weeks.
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Memantine plus Individualized Management of AD
10 subjects who previously participated in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study will be enrolled in this cohort.
These subjects received memantine plus individualized management of AD for a period of 28 weeks.
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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 |
時間枠 |
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Total number of prescription medications taken throughout the study
時間枠：28 weeks
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28 weeks
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Total number of hospitalizations
時間枠：28 weeks
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28 weeks
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The total number of new medical conditions
時間枠：28 weeks
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28 weeks
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Total number of days of hospice care
時間枠：28 weeks
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28 weeks
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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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Total number of psychotropic medications used
時間枠：28 weeks
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28 weeks
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Total number of increases in psychotropic medications
時間枠：28 weeks
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28 weeks
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Total number of decreases in psychotropic medications
時間枠：28 weeks
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28 weeks
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Total number of cardiac medications taken during the study
時間枠：28 weeks
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28 weeks
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Total number arthritic and anti-inflammatory medications taken during the study
時間枠：28 weeks
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28 weeks
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Total number of analgesic medications taken during the study
時間枠：28 weeks
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28 weeks
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Total number of days hospitalized during the study
時間枠：28 weeks
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28 weeks
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Reasons for hospitalizations and hospital diagnoses during the study
時間枠：28 weeks
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This endpoint will be examined qualitatively; no statistical analysis will be performed but the data will be compiled and reported for illustrative purposes
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28 weeks
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Total number of tests and procedures performed during the hospitalizations
時間枠：28 weeks
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28 weeks
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Changes in Functional Assessment Staging Disability Score (FAST-DS) at subsequent study visits post hospitalization
時間枠：28 weeks
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The FAST-DS assesses the magnitude of progressive functional deterioration by identifying characteristic progressive disabilities in participants with AD. Scores range from 1.0 (normal) to 7f (severe loss of ability, not even able to hold up head independently). Scores are made up of stages (1 through 7) and substages (from a to e for stage 6; from a to f for stage 7). The following scoring for substages is applied: 6a=6.0, 6b=6.2, 6c=6.4, 6d=6.6, 6e=6.8, 7a=7.0, 7b=7.2, 7c=7.4, 7d=7.6, 7e=7.8, 7f=8.0. Additionally, non-consecutive deficits are noted and scored as follows: full stage non-consecutive deficit=1.0, non-consecutive substage deficit=0.2. The overall FAST-DS score = (FAST Stage Score) + (Each Non-Consecutive FAST disability scored as described) |
28 weeks
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Time to death
時間枠：28 weeks
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28 weeks
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Cause of death
時間枠：28 weeks
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This endpoint will be examined qualitatively; no statistical analysis will be performed but the data will be compiled and reported for illustrative purposes
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28 weeks
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Caregiver training and support in relation to mortality
時間枠：28 weeks
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This endpoint will be examined qualitatively; no statistical analysis will be performed but the data will be compiled and reported for illustrative purposes
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28 weeks
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Differences in rate of fecal incontinence
時間枠：28 weeks
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28 weeks
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Differences in rate of urinary incontinence
時間枠：28 weeks
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28 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Barry Reisberg, MD、NYU Langone Health
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。
アルツハイマー病の臨床試験
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