JP2017078720A - 心的外傷後ストレス障害(ptsd)のための診断用バイオマーカーを検出及び監視するため、並びに同障害の自殺型と非自殺型とを識別するためのプロセス及びキット - Google Patents
心的外傷後ストレス障害(ptsd)のための診断用バイオマーカーを検出及び監視するため、並びに同障害の自殺型と非自殺型とを識別するためのプロセス及びキット Download PDFInfo
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Abstract
【解決手段】PTSDを有する疑いのある対象及び/又は希死念慮傾向性を有する対象の生物学的検体中のP−11、UBE3A、STY1、EMAP−11、SIP1、ORC5L、DCX、SCYEタンパク質等の、少なくとも1つのマーカー量を、精神障害を有さない正常な対象における前記少なくとも1つのマーカーの正常な対象の量、又は前記罹患対象の前記少なくとも1つのマーカーの過去の量と比較すること、を含み、前記量と、前記正常な対象の量又は前記過去の量との差が、前記罹患対象における精神障害の指標である方法。
【選択図】図7
Description
本出願は、2011年9月14日に出願された米国特許仮出願第61/534,560号及び2011年12月11日に出願された米国特許仮出願第61/569,047号の優先権を主張する。各関連出願は、参照により本明細書に組み込まれるものとする。
米国政府支援
体外診断装置
タンパク質バイオマーカー
キット
実施例1
患者
精神医学的診断
生物学的検体採取
生物学的検体中のタンパク質
結果
実施例2
実施例3
実施例4
実施例5
Claims (18)
- 精神障害の存在を判定するプロセスであって、
精神障害の疑いのある罹患対象から生物学的検体を採取することと、
少なくとも1つのマーカーが、(i)シナプトタグミン1(STY1);(ii)ユビキチンタンパク質リガーゼE3Aポリメラーゼ(UBE3A);(iii)デルタ1触媒サブユニット125kDa、(iV)小誘導性サイトカインサブファミリーE、メンバー1(SCYE1);(v)非転移性細胞1タンパク質(NM23A);(vi)タンパク質キナーゼC様1;核タンパク質、毛細血管拡張性運動失調症遺伝子座;(vii)モノクローナル抗体Ki−67によって特定される抗原;(viii)ホスホリパーゼCベータ1(ホスホイノシチド特異的);(ix)カリウム電位依存性チャネル、サブファミリーH(eag関連)、メンバー6;(x)内皮単球活性化ポリペプチド(EMAP−II);(xi)生存運動ニューロンタンパク質結合タンパク質(SIP1);(xii)複製開始点認識複合体サブユニット5様タンパク質(ORC5L);(xiii)ダブルコルテックス;X染色体連鎖性滑脳症(DCX);(xiv)ユビキチンカルボキシル末端エラスターゼL−1(UCH−L1);(xv)グリア筋原繊維酸性タンパク質(GFAP);(xvi)α2−スペクトリン;(xvii)シナプトフィシン、(xviii)α−シヌクレイン、(xix)ニューログラニン、(xx)S−100β、(xxi)ニューロフィラメントタンパク質F、H及びN、(xxii)マイクロチューブリンタンパク質、(xxiii)ミエリン塩基性タンパク質、(xxiv)コラプシン応答仲介タンパク質(CRMP)、及び(xxv)P−11、並びに(xxxvi)P2RX7、或いはこれらの組み合わせであり、精神障害に関連する前記少なくとも1つのマーカーの量について前記検体を測定することと、
前記少なくとも1つのマーカーの量を、精神障害を有さない正常な対象における前記少なくとも1つのマーカーの正常な対象の量、又は前記罹患対象の前記少なくとも1つのマーカーの過去の量と比較することと、を含み、
前記量と、前記正常な対象の量又は前記過去の量との差が、前記罹患対象における精神障害の指標である、プロセス。 - 前記少なくとも1つのマーカーが、UBE3A、STY1、EMAP−II、SIP1、ORC5L、DCX、SCYE、UCH−L1、P−11又はこれらの組み合わせのタンパク質である、請求項1に記載のプロセス。
- 前記プロセスが、
心的外傷後ストレス障害(PTSD)を有する疑いのある男性患者を選択することと、
PTSDを有する疑いのある対象から得た生物学的検体中の、PTSDに関連する、ユビキチン結合酵素E2L 3;Fas(TNFRSF6)結合デスドメインタンパク質;タンパク質キナーゼAMP活性化ベータ1非触媒サブユニット;カリクレイン10;マイトジェン活性化タンパク質キナーゼ4;TAF6 RNAポリメラーゼII、TATAボックス結合タンパク質(TBP)関連因子80kDa;タンパク質キナーゼCアルファ;DNA断片化因子45kDaアルファポリペプチド;テトラトリコペプチド反復配列4を有するインターフェロン誘導性タンパク質;ストリアチン・カルモジュリン結合タンパク質;ホスホイノシチド−3−キナーゼ触媒性アルファポリペプチド;腫瘍壊死因子受容体・スーパーファミリーメンバー6;核自己抗原性精子タンパク質(ヒストン結合);rasホモログ遺伝子ファミリー、メンバーA;NIMA(never in mitosis gene a)関連キナーゼ2;クロマチンのSWI/SNF関連マトリックス結合アクチン依存性レギュレータサブファミリーaメンバー2;アリール炭化水素受容体核トランスロケータ;シナプトソーム結合タンパク質91kDaホモログ(マウス);G1〜S期移行2;又はインテグリンアルファ2(CD49B、VLA−2受容体のアルファ2サブユニット)のうちの少なくとも1つのPTSDマーカーの量について、前記検体を測定することと、
前記少なくとも1つのタンパク質の量を、PTSD又はその他の精神障害を有さない正常な対象における前記少なくとも1つのマーカーの正常な対象の量又は前記罹患対象の前記少なくとも1つのマーカーの過去の量と比較することと、を更に含み、
前記量と、前記正常な対象の量又は前記過去の量との差が、前記罹患対象における精神障害の指標である、請求項1に記載のプロセス。 - 前記プロセスが、
心的外傷後ストレス障害(PTSD)を有する疑いのある女性患者を選択することと、
PTSDを有する疑いのある対象から得た生物学的検体中のPTSDに関連する、生存運動ニューロンタンパク質結合タンパク質1(SIP1);プラコフィリン2;分泌タンパク質SEC8;上皮細胞増殖因子受容体経路基質8;ジアシルグリセロールキナーゼシータ110kDa;セントロソームタンパク質2;一般転写因子IIFポリペプチド2 30kDa;ニューロゲニン3;又はADP−リボシルトランスフェラーゼの中の少なくとも1つのPTSDマーカーの量について、前記検体を測定することと、
前記少なくとも1つのタンパク質の量を、PTSD又はその他の精神障害を有さない正常な対象における前記少なくとも1つのマーカーの正常な対象の量又は前記罹患対象の前記少なくとも1つのマーカーの過去の量と比較することと、を更に含み、
前記量と、前記正常な対象の量又は前記過去の量との差は、前記罹患対象における精神障害の指標である、請求項1に記載のプロセス。 - 前記プロセスが、
自殺型の疑いのある患者を選択することと、
自殺型の疑いのある対象から得た生物学的検体中の自殺型に関連する、P−11又はP2RX7である少なくとも1つのマーカーの量について、前記検体を測定することと、
前記少なくとも1つの自殺マーカーの量を、自殺型ではない対象又はその他の精神障害を有さない正常な対象における前記少なくとも1つの自殺マーカーの正常な対象の量、若しくは前記罹患対象の前記少なくとも1つの自殺マーカーの過去の量と比較することと、を更に含み、
前記量と、前記正常な対象の量又は前記過去の量との差が、前記罹患対象における自殺の指標である、請求項1に記載のプロセス。 - 前記生物学的検体が、全血、血漿、血清、CSF、尿、唾液、汗、前頭前皮質組織、海馬組織、又は同側性皮質組織である、請求項1、3、4又は5に記載のプロセス。
- 時間の関数として連続生物学的検体を採取し、回復の指標として、前記量が前記正常な対象の量又は前記過去の量と実質的に等しくなるまで、前記罹患対象の前記生物学的検体中の前記少なくとも1つのマーカー、PTSDマーカー又は自殺マーカーの前記量の経時変化を監視することを更に含む、請求項1、3、4又は5に記載のプロセス。
- 精神障害を治療するために治療薬を投与することと、連続生物学的検体を時間の関数として採取して、回復及び治療の有効性の指標として、前記量が前記少なくとも1つのマーカー、PTSDマーカー又は自殺マーカーの前記正常な対象の量又は前記過去の量と実質的に等しくなるまで、前記罹患対象の前記生物学的検体中の前記少なくとも1つのマーカー、PTSDマーカー又は自殺マーカーの前記量の経時変化を監視することとを更に含む、請求項1、3、4又は5に記載のプロセス。
- 請求項1、3、4又は5に記載のプロセスを使用するキットであって、
ヒト対象から単離された生物学的検体を保持するための基材と、
精神障害に関連する前記少なくとも1つのマーカー、PTSDマーカー又は自殺マーカーと特異的に相互作用する薬剤と、
対象における精神障害を診断するために、前記薬剤を前記検体又は前記検体の一部分と反応させて、前記マーカーの前記存在又は量を検出するための印刷された説明書と、を含むキット。 - 前記薬剤が、前記少なくとも1つのマーカー、PTSDマーカー又は自殺マーカーに対してそれぞれの自己抗体に特異的かつ独立して結合する抗原である、請求項9に記載のキット。
- 前記薬剤が、前記少なくとも1つのマーカー、PTSDマーカー又は自殺マーカーのそれぞれのタンパク質に特異的かつ独立して結合する抗体である、請求項9に記載のキット。
- 前記1つ以上の薬剤が、前記生物学的検体中の前記少なくとも1つのマーカー、PTSDマーカー又は自殺マーカーに結合するかどうかを判定するために酵素結合免疫吸着検定法(ELISA)が使用される、請求項9に記載のキット。
- 対象における精神障害を検出するための体外診断装置であって、
前記対象から採取された第1の生物学的検体を保持するための検体チャンバと、
前記検体チャンバと流体連通しており、請求項1、3、4又は5に記載の前記プロセスを使用するアッセイモジュールと、
電源と、
前記電源と前記アッセイモジュールに動作可能に通信するデータ処理モジュールと、を備え、前記アッセイモジュールが、前記第1の生物学的検体を分析し、前記生物学的検体中に存在する精神障害に関連する前記タンパク質マーカーの少なくとも1つを検出し、前記第1の生物学的検体中の検出されたマーカーの存在を、前記データ処理モジュールに電気的に通信し、
前記データ処理モジュールが、前記対象における神経損傷又はニューロン障害を検出することに関連する出力と、前記測定されたマーカーの前記量、前記精神障害の存在又は不在、或いは前記精神障害の前記重症度である出力とを有する、装置。 - 前前記第1の検体が採取された後に同時に、前記対象から得た第2の生物学的検体を分析することを更に含み、前記装置が、前記第1の検体に対して前記第2の検体中で前記測定されたマーカーの異なる量を検出したときに、前記データ処理モジュールによって、前記経時変化を指摘する出力が提供される、請求項13に記載の装置。
- データ処理モジュールと電気的に通信し、精神医学的マーカーの量、前記精神医学的マーカーの量と対象の量の間の比較、精神障害の存在、又は精神障害の重症度の少なくとも1つとして前記出力を表示するディスプレイを更に含む、請求項13に記載の装置。
- 前記出力を遠隔地に通信するための送信器を更に含む、請求項13に記載の装置。
- 前記出力がディジタルである、請求項1に記載の装置。
- 対象における神経損傷又はニューロン障害を検出するための体外診断装置であって、
前記対象から得た第1の生物学的検体を保持するためのハンドヘルド検体チャンバと、
前記検体チャンバと流体連通しており、請求項1、3、4又は5を使用するアッセイモジュールと、
前記第1の生物学的検体中に存在する少なくとも1つの測定された精神医学的マーカーに応答する比色変化を提供する染料と、を含む装置。
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