40歳以上のダウン症候群 (MEADOWS) の成人の認知症に対するメマンチン:ランダム化,ダブルブラインド,プラセボ対照試験
Marisa Hanney1, Vee Prasher, Nicola Williams
1Wolfson Centre for Age-Related Diseases, King's College London, London, UK.
Lancet (London, England)
|January 13, 2012
まとめ
メマンタインは,アルツハイマー病の薬物研究にもかかわらず,ダウン症候群を有する40歳以上の成人の認知や機能を改善しませんでした. この研究は,この集団に対する特定の治療法の必要性を強調しています.
科学分野:
- 神経学 神経学とは
- 遺伝学 遺伝学とは
- 薬理学 薬理学とは
背景:
- ダウン症候群の個人は40歳以降,アルツハイマー病の病理学的有病率が高くなります.
- この集団におけるアルツハイマー病の薬効性に関する既存の証拠は限られている.
- メマンチンは,前臨床モデルにおいて有望な結果を示したが,臨床評価が必要であった.
研究 の 目的:
- 40歳以上のダウン症候群の成人の認知機能と機能の改善におけるメマンタインの安全性と有効性を評価する.
- この特定の人口集団における認知および適応行動に対するメマンチンの影響を評価する.
主な方法:
- ダウン症候群の成人 (>40歳) を対象とした前向き,ランダム化,ダブルブラインド試験.
- 参加者は52週間にわたってメマンチンまたはプラセボを投与されました.
- 認知と機能は,主にダウン症候群の注意力,記憶力,実行機能スケール (DAMES) と適応行動スケール (ABS) を使用して測定されました.
主要な成果:
- メマンチンとプラセボの両グループは,認知機能と機能の低下を示し,グループ間の有意な違いはありませんでした.
- 調整された分析は,DAMESとABSのスコアについてプラセボを好む非重要な差異を明らかにした.
- 深刻な有害事象と死亡率は,メマンチン群とプラセボ群の間で類似していました.
結論:
- メマンタンは,ダウン症候群の40歳以上の個人の認知障害や認知症の効果的な治療法ではありません.
- アルツハイマー病に有効な治療法は,ダウン症候群の集団において有効性にはならない可能性があります.
- このグループでは,薬理学的介入の証拠が著しく欠けている.
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