Rivastigmine Study in Adolescents With Down Syndrome (DS-Riv)
A 20-Week Double-Blind Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of Rivastigmine in Children (Ages 10-18) With Down Syndrome
調査の概要
詳細な説明
This 24 week, double-blind, placebo controlled trial will be completed at the Clinical Research Unit of Duke University Medical Center and at the Kennedy Krieger Institute (KKI). Sixteen evaluable subjects will be enrolled at Duke and 24 evaluable subjects will be enrolled at KKI. The study consists of four visits, a screening visit (-4 weeks), a baseline visit (week 0); a safety visit at week 10, and a final/termination visit at week 20.
The specific aims of this study are to: a) investigate efficacy of rivastigmine tartrate treatment; b) build upon our open-label treatment results of overall function and language improvement in adolescents with Down syndrome (DS) in a double-blind, placebo-controlled clinical trial; and c) investigate other specific cognitive domains that may selectively respond to rivastigmine tartrate treatment.
The original IRB-approved protocol included the Parent/Caregiver Rating Form of the Vineland Adaptive Behavior Scales- Second Edition (VABS-II) . The protocol was amended to replace the Parent/Caregiver Rating Form of the Vineland Adaptive Behavior Scales- Second Edition (VABS-II) with the Vineland Adaptive Behavior Scales, Second Edition, Survey Interview Form. The protocol was also amended to extend the trial from 12 weeks to 20 weeks. Due to the changes in the amended protocol the subject enrolled prior to the IRB amendment will not be included in the data analysis section.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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Maryland
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Baltimore、Maryland、アメリカ、21205
- Kennedy Krieger Institute
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North Carolina
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Durham、North Carolina、アメリカ、27710
- Duke University Medical Center
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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
説明
Inclusion Criteria:
- Correct VERBAL responses for 7/9 of the Expressive One Word Picture Vocabulary Test items.
- Subject able to put at least 2-3 words together in conversational speech.
- Subject's speech is understandable to the examiner for the majority of the time.
- Subjects are in good health and medically stable
Exclusion Criteria:
- Subject uses sign language as a primary means of communication
- Subject has a medical history that contraindicate the use of rivastigmine (For example, patients with active seizure disorders, asthma, celiac disease, heart disease or heart rhythm disorders).
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
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- Liquid form
At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid.
This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks.
At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks.
If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid.
If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
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At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid.
This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks.
At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks.
Subjects receiving placebo will maintain the same schedule.
If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid.
If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
他の名前：
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プラセボコンパレーター：Liquid placebo
Subjects receiving placebo will maintain matched titration volume increase as treatment arm.
The placebo will be matched to liquid rivastigmine in consistency and taste.
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Subjects receiving placebo will maintain matched titration volume increase as treatment arm.
The placebo will be matched to liquid rivastigmine in consistency and taste.
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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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Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form)
時間枠：Baseline & Study termination (Week 20)
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The Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) is a measure of adaptive behavior in children, adolescents and adults.
It yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains.
ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160).
Higher scores suggest a higher level of adaptive functioning.
In this study, the change between each subject's ABC at Baseline and the Final Visit was computed.
A rise in standard scores from Baseline to the Final Visit indicates improvement.
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Baseline & Study termination (Week 20)
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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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Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P)
時間枠：Baseline and Final (Week 20) visit
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The Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) is a parent report measure of executive function behaviors in children in their home setting.
It yields an overall score (Global Executive Composite, GEC) that is based on its five clinical scales.
Raw scores range from 63 to 189.
Higher scores suggest that an individual's executive function skills are more problematic.
In this study, the change between each subject's raw score at Baseline and the Final Visit was computed for the Global Executive Composite.
A decline in raw scores from Baseline to the Final Visit indicates improvement.
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Baseline and Final (Week 20) visit
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協力者と研究者
スポンサー
捜査官
- 主任研究者：George Capone, MD、Kennedy Krieger Institute/Johns Hopkins
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 (見積もり)
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
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