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APOE遺伝子型に関連する身体活動、アルツハイマー病および認知 (PAAD-2)

2026年8月19日 更新者：University of North Carolina, Greensboro

APOE 遺伝子型 (PAAD-2) に関連する認知に対する身体活動の影響

身体活動とアルツハイマー病 (PAAD-2) は、家族歴によりアルツハイマー病 (AD) のリスクが高い中年 (40 ～ 65 歳) の認知的に正常な成人に対する運動の効果を評価する無作為対照試験です。 (FH+)。 研究者はまた、この効果がアポリポタンパク質イプシロン-4 (APOE4) キャリアの状態によって緩和される程度を評価し、アルツハイマー病のリスクが最も高い人々の認知能力を改善するための身体活動の使用に関する重要な新しい実験的証拠を収集します. .

調査の概要

状態

完了

条件

介入・治療

詳細な説明

この研究では、研究者は、身体活動が認知能力とその根底にあるメカニズムに及ぼす影響を調査する過去の研究をフォローアップしています。 特に、研究者は、アルツハイマー病の人の遺伝的リスクの関数として実現される可能性のある異なる影響に関心を持っています. この研究では、研究者はランダム化された臨床試験を提案することにより、過去の研究を拡張します。効果がアポリポタンパク質イプシロン-4 (APOE4) キャリア状態によって緩和されるかどうかを判断します。 研究者は、脳構造、白質の完全性、および安静状態の接続性に関する神経画像測定を収集します。推定生物学的マーカーを評価します。そして（調整された調停分析を使用して）根底にあるメカニズムと、影響がAPOE4保因者の状態によってどの程度調整されるかについての理解を深めます。 仮説を検証するために、研究者は 240 人の認知的に正常な中年成人を 1 年間の仮想身体活動プログラムまたは通常のケア コントロールに無作為に割り当てます。 介入対象者は、自分で行う有酸素運動や、インストラクターと一緒に 1 時間/日、週 3 日、1 年間の仮想運動セッションで行われる抵抗運動を含む、1 年間にわたる身体活動プログラムに参加します。 通常のケアコントロール状態にある人は、通常のライフスタイルを1年間維持するように求められ、その後、短期間のフィットネスセンターのメンバーシップが与えられます（テストセッションの完了を条件とします）. 調査員は、テスト前、テスト中、テスト後の認知能力を評価し、テスト前、テスト中、テスト後に MRI スキャンと血液サンプルを取得します。 研究者は、身体活動が認知能力と神経学的および生物学的メカニズムに及ぼす影響を調べ、APOE4 の緩和の役割を調査します。

研究の種類

介入

入学 (実際)

180

段階

  • 適用できない

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

  • アメリカ
    • North Carolina
      • Greensboro、North Carolina、アメリカ、27402
        • University of North Carolina-Greensboro

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

40年～65年 (大人、高齢者)

健康ボランティアの受け入れ

はい

説明

包含基準:

  • アルツハイマー病、認知障害の家族歴
  • 英語でコミュニケーションがとれる方
  • 現在、身体活動の推奨事項を満たしていません (推奨事項は、週 3 日、1 日 30 分以上の運動を 3 か月以上行うことです)。
  • -いずれかの研究条件に無作為化されることをいとわない
  • 1年間のすべての学習活動を完了したい

除外基準:

  • 臨床的認知障害の基準を満たす
  • 既知の心血管疾患、代謝疾患、または腎疾患のために身体活動を行うことができず、症状があるか、または整形外科の制限が原因である
  • -交絡神経学的、精神医学的、または活動的な重度または機能的に無効な神経疾患または医学的疾患、または運動を制限するか、患者に危険をもたらす可能性のあるその他の状態の自己報告の歴史
  • 認知に悪影響を与える、または心拍数に影響を与えるアルツハイマー病の症状を治療するための薬物の現在の使用
  • Center for Epidemiological Studies Depression Scale の短縮形を使用してうつ病の基準を満たす
  • -研究の過程で長期間（> 1か月）旅行する

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：基礎科学
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：身体活動状態 (PAC)
被験者は、1年間にわたって週に3回、仮想エクササイズセッションに参加するよう求められます。
行動：身体活動状態
被験者は、仮想グループエクササイズセッションに週3回、1年間参加します。 各被験者は、安静時の HR と年齢に応じて、適度な強度 (目標心拍数 (HR) = 40 ～ 59% の HR リザーブ) で歩くように勧められます。 被験者は自分で有酸素運動を行い、抵抗運動はインストラクターとの仮想運動セッションで1日1時間、週3日、1年間完了します。 運動セッションでは、これらの参加者は完了した運動の測定値を記録するように求められ、心拍数 (20 秒間の触診によって評価) および知覚運動 (RPE) の測定値を提供するように求められる場合があります。 彼らは、この情報を提供する運動ログを提出するよう求められます。 運動ログと運動スペシャリストの記録からのデータは、進行の証拠、中程度の強度の一貫した達成、および有酸素および筋力トレーニングコンポーネントの所定の期間に関してレビューされます。
介入なし：通常のケアコントロール (UCC)
通常のケアコントロールの参加者は、1年間通常の健康習慣を維持します。 参加者は隔週の健康ニュースレターを受け取り、質問に答えたり、参加者の健康状態について尋ねたりするために隔週で連絡されます。 参加者の自己申告による身体活動は毎月評価されます。 このようにして、参加者には毎週スタッフから連絡が入ります。 テスト前、中間、テスト後を含むすべての研究関連活動を完了した通常のケアコントロール参加者は、テスト後、短期 YMCA 会員権を受け取ります。

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
Change in Performance on the Cognitive Domain of Executive Function as Measured With Stroop Interference Reaction Time (RT)
時間枠：Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in executive function will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on Stroop Interference. Stroop interference is calculated using reaction time (RT) data from correct trials and the following formula: Stroop Interference RT = Stroop Incongruent RT - (average (Stroop Congruent RT , Stroop Neutral RT)). Stroop Congruent is also known as Stroop Word, and Stroop Neutral is also known as Stroop Color. RT is recorded in msec and a larger score is indicative of greater interference (worse performance)
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Executive Function as Measured With Trail Making Test Interference
時間枠：Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in executive function will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the Comprehensive Trail Making Test (TMT) interference. TMT interference is calculated as total time to complete TMT B (also called Trail 5) minus the total time to complete TMT A (also called Trail 1)which were both recorded in seconds. TMT interference is, therefore, recorded in seconds with a larger score indicative of greater interference (worse performance)
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Executive Function as Measured With NIH Toolbox Dimensional Change Card Sort
時間枠：Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in executive function will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the NIH Toolbox Dimentional Change Card Sort Test (DCCS). We used the recommended outcome of the DCCS computed score. This is calculated automatically within the NIH Toolbox based upon a two-stage process combining a score of 0-5 from the accuracy data with a score of 0-5 from the reaction time data. Thus, scores range from 0-10 with a higher score indicative of better performance.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Executive Function as Measured With the NIH Toolbox Flanker Test.
時間枠：Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in executive function will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the NIH Toolbox Flanker Inhibitory Control and Attention Test. We used the recommended outcome of the Flanker computed score. This is calculated automatically within the NIH Toolbox based upon a two-stage process combining a score of 0-5 from the accuracy data with a score of 0-5 from the reaction time data. Thus, scores range from 0-10 with a higher score indicative of better performance.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Memory as Measured With the Auditory Verbal Learning Test.
時間枠：Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in memory will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the Auditory Verbal Learning Test. Majdan et al. (1996) Form 1 was given at pre, the standard Rey Auditory Verbal Learning list was given at mid, and Majdan et al. (1996) Form 2 was given at post. These versions are comparable in terms of their scores (Sherman, Tan, & Hrabok, 2022). Possible scores range from 0-15 with a bigger score being indicative of better memory.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Memory as Measured With the Rey-Osterrieth Complex Figure Test
時間枠：Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in memory will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the Rey Osterreith Complex Figure Test. Tests were scored using the deep learning approach for automated scoring published by Langer et al. eLife 2024;13:RP96017. DOI: https://doi.org/10.7554/eLife.96017. Possible scores range from 0-36 with higher scores being indicative of better memory.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Memory as Measured With the NIH Toolbox Picture Sequence Test
時間枠：Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in memory will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the NIH Toolbox Picture Sequence Memory Test - The computed score is an IRT-based theta score of the number of adjacent pairs placed for trial 1 and 2 with a higher score being indicative of better memory. This score is automatically created within the NIH Toolbox. Version A was given at pre, Version B was given at mid, and Version C was given at post. Possible scores range from 200-700 with a higher score being indicative of better performance.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Memory as Measured With the Mnemonic Similarity Test
時間枠：Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in memory will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) Lure Discimination Index (LDI) on the Mnemonic Similarity Test (MST). The MST was created based upon the publicly available and validated instructions and stimuli provided by the creators of the task (Stark, Kirwan, & Stark, 2019). Equivalent versions of the test are administered so participants see different stimuli at each testing session and those stimuli were counterbalanced to rotate through the different item types. The formula for calculating the LDI is: p(similar|lure) - p(similar|foil) where p(similar|lure) = Total # of "similar" responses to lure items / 36 and p(similar|foil) = Total # "similar" responses to foil items / 36. Scores range from -1 to +1 with a larger score indicating better discrimination performance.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Attention as Measured With the Paced Auditory Serial Addition Test
時間枠：Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in attention will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the 2-sec trial of the Paced Auditory Serial Addition Task. Scores are reported as the number of correct responses with possible scores ranging from 0-60 and larger scores being indicative of better attention.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Attention as Measured With the Forward Digit Span Test
時間枠：Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in attention will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the Neurological Assessment Battery (NAB) Digit Span Forward test. Scores are reported as the number of correct trials with possible scores ranging from 0-14 and larger scores being indicative of better attention.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Working Memory as Measured With NIH Toolbox List Sort Working Memory
時間枠：Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in working memory will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the NIH Toolbox List Sort Working Memory Test. Scores are reported as the sum of the total number of items correctly recalled and sequenced on Lists 1 and 2 with possible scores ranging from 0-26 and larger scores being indicative of better working memory.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Working Memory as Measured With Spatial Working Memory
時間枠：Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in working memory will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) reaction time on the 4-dot trial of the Spatial Working Memory Test. Scores are reported as the average reaction time (RT) for correct responses. Smaller scores are indicative of faster performance (i.e., better performance).
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Working Memory as Measured With Backward Digit Span
時間枠：Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in working memory will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) accuracy on the Neurological Assessment Battery (NAB) Digit Span Backwards test. Scores are reported as the number of correct trial with possible scores ranging from 0-14 and larger scores being indicative of better working memory.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Processing Speed as Measured With the Digit Symbol Modalities Test (SDMT)
時間枠：Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in working memory will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the Digit Symbol Modalities Test (SDMT) (Smith, 1973). Scores are reported as the sum of Oral and Written Trial Raw Scores (correct responses) with possible scores ranging from 0-220 and larger scores being indicative of better working memory.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Processing Speed as Measured With the Stroop Word Test
時間枠：Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in processing speed will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on Stroop Word condition (also known as the Stroop Congruent condition). RT is recorded in msec and a larger score is indicative of slower performance (worse performance)
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Processing Speed as Measured With the Stroop Color Test
時間枠：Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in processing speed will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on Stroop Color condition (also known as the Stroop Neutral condition). RT is recorded in msec and a larger score is indicative of slower performance (worse performance)
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Processing Speed as Measured With the Trail Making Test A
時間枠：Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in executive function will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the Comprehensive Trail Making Test (TMT) A (TMT A) (also known as Trail 1). Performance is recorded in seconds with a larger score indicative of slower performance (worse performance)
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Executive Function as Measured With Matrix Reasoning.
時間枠：Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in executive function will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on Matrix Reasoning Accuracy from the Virginia Cognitive Aging Project (VCAP). Version O was given at pre, Version A was given at mid, and Version B was given at post. Possible scores are proportions that range from 0-1 (i.e., 0% accuracy to 100% accuracy expressed on a 0.00-1.00 scale) with a higher score being indicative of better performance.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Brain Morphology (Whole Brain Volume)
時間枠：Pre-Test and Post-Test (~12 months)
Change in whole brain morphology will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) for total segmented brain volume (i.e., total brain separated from non-brain structures). This is measured as volume (mm3), with volumes ranging from 1,050,000 to 1,350,000, and with higher values being interpreted as better.
Pre-Test and Post-Test (~12 months)
Change in Brain Morphology (Left Hippocampus Volume)
時間枠：Pre-Test and Post-Test (~12 months)
Change in Left Hippocampus Volume will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) for total segmented left hippocampus volume (i.e., left hippocampus segmented away from other regions). This is measured as volume (mm3), ranges from 2500 to 4500, and higher values are better.
Pre-Test and Post-Test (~12 months)
Change in Brain Morphology (Right Hippocampus Volume)
時間枠：Pre-Test and Post-Test (~12 months)
Change in Right Hippocampus Volume will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) for total segmented right hippocampus volume (i.e., right hippocampus segmented away from other regions). This is measured as volume (mm3), ranges from 2500 to 4500, and higher values are better.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - BDNF
時間枠：Pre-Test and Post-Test (~12 months)
Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - Irisin
時間枠：Pre-Test and Post-Test (~12 months)
Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - IGF-1
時間枠：Pre-Test and Post-Test (~12 months)

Change in blood biomarkers (BDNF, irisin, IGF-1, glucose, insulin, TNF-⍺, serum amyloid protein (SAP), albumin, ApoE and ⍺-2 macroglobulin) - IGF-1. Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.

The capture antibodies in the kits we received from the company for IGF-1 were not effective. We attempted to secure new kits to conduct the assays, but did not receive the kits in a timely fashion. We intend to conduct these assays upon receipt of the kits and the availability of personnel to perform the assays. The anticipated reporting date for IGF-1 is January 2027.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - Glucose
時間枠：Pre-Test and Post-Test (~12 months)
Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - Insulin
時間枠：Pre-Test and Post-Test (~12 months)
Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - TNFa
時間枠：Pre-Test and Post-Test (~12 months)
Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - SAA
時間枠：Pre-Test and Post-Test (~12 months)
Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - ALB
時間枠：Pre-Test and Post-Test (~12 months)
Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - ApoE
時間枠：Pre-Test and Post-Test (~12 months)
Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - ⍺-2 Macroglobulin
時間枠：Pre-Test and Post-Test (~12 months)
Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.
Pre-Test and Post-Test (~12 months)
Change in Cardiorespiratory Fitness
時間枠：Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Fitness will be assessed by comparing predicted VO2max at Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months). Fitness will be assessed using a submaximal graded aerobic exercise test performed on a treadmill. Oxygen uptake (VO2) at each stage is estimated based on the treadmill speed and grade during a ramped exercise protocol performed until volitional exhaustion or test termination due to symptom limitations. The VO2max estimation uses the slope of the regression line between the heart rates (HR) of the last two stages to extrapolate to the participant's predicted VO2 at their age-predicted max HR (220-age). If HR at either of the last two stages is <110, VO2 could not be reliably calculated, and we consider the participant to have insufficient data (ID). We have explored other options for estimating VO2 max, but believe this is the best option available.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Brain Activity (Resting-state Connectivity) Right Lateral Parietal, Posterior Cingulate Cortex
時間枠：Pre-Test and Post-Test (~12 months)
Functional MRI will be used to measure brain activity including resting-state connectivity and change will be assessed from pre-test to post-test.
Pre-Test and Post-Test (~12 months)
Change in Brain Activity (Resting-state Connectivity) Left Lateral Parietal, Right Lateral Parietal
時間枠：Pre-Test and Post-Test (~12 months)
Functional MRI will be used to measure brain activity including resting-state connectivity and change will be assessed from pre-test to post-test.
Pre-Test and Post-Test (~12 months)
Change in Brain Activity (Resting-state Connectivity) Left Lateral Parietal, Posterior Cingulate Cortex
時間枠：Pre-Test and Post-Test (~12 months)
Functional MRI will be used to measure brain activity including resting-state connectivity and change will be assessed from pre-test to post-test.
Pre-Test and Post-Test (~12 months)
Change in Brain Activity (Resting-state Connectivity) Medial Prefrontal Cortex, Posterior Cingulate Cortex
時間枠：Pre-Test and Post-Test (~12 months)
Functional MRI will be used to measure brain activity including resting-state connectivity and change will be assessed from pre-test to post-test.
Pre-Test and Post-Test (~12 months)
Change in Brain Activity (Resting-state Connectivity) Medial Prefrontal Cortex, Right Lateral Parietal
時間枠：Pre-Test and Post-Test (~12 months)
Functional MRI will be used to measure brain activity including resting-state connectivity and change will be assessed from pre-test to post-test.
Pre-Test and Post-Test (~12 months)
Change in Brain Activity (Resting-state Connectivity) Medial Prefrontal Cortex, Left Lateral Parietal
時間枠：Pre-Test and Post-Test (~12 months)
Functional MRI will be used to measure brain activity including resting-state connectivity and change will be assessed from pre-test to post-test.
Pre-Test and Post-Test (~12 months)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of North Carolina, Greensboro

協力者

National Institute on Aging (NIA)
Wake Forest University Health Sciences

捜査官

  • 主任研究者：Jennifer Etnier, PhD、UNC Greensboro

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。

一般刊行物

便利なリンク

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 (実際)

2019年5月23日

一次修了 (実際)

2024年12月21日

研究の完了 (実際)

2024年12月21日

試験登録日

最初に提出

2019年1月24日

QC基準を満たした最初の提出物

2019年3月12日

最初の投稿 (実際)

2019年3月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月21日

QC基準を満たした最後の更新が送信されました

2026年8月19日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 18-0228
  • R01AG058919 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

データ文書および匿名化されたデータは、適用される法律および規制に従って共有するために保管されます。 データは、匿名化された匿名の状態で .csv で利用できます フォーマット。 データは、RedCap から .csv にデータをエクスポートすることで共有されます ファイルは、ノースカロライナ大学グリーンズボロ校 (UNCG) 大学図書館の機関リポジトリ ノースカロライナ デジタル オンライン コレクション オブ ナレッジ アンド スカラーシップ (NC DOCKS) の研究主任研究者の機関プロファイルの下にアーカイブされています。

データは、グローバル アルツハイマー病協会インタラクティブ ネットワーク (GAAIN) を通じても共有されます。GAAIN は、データ共有を促進し、アルツハイマー関連データに関心のある研究者のためのコラボレーションの開発を促進するように設計された連合データ システムです。 興味のある科学者は、PAAD-2 や他の研究からのメタデータを調べることができます。 パートナーになることで、PAAD-2 の説明と主任研究者に連絡するためのリンクが www.gaain.org で利用できるようになります。

IPD 共有時間枠

Collaboration for Alzheimer's Prevention (CAP) の推奨に従って、事前無作為化データは登録完了から 12 か月以内に保管されます。 国立衛生研究所 (NIH) のガイドラインに従い、無作為化後のデータは、研究の主な結果が発表されるまで公開されません (つまり、 特定の目的に関連する調査結果) または研究終了から 2 年後 (いずれか早い方)。 禁輸期間が終了する前に提出されたデータ共有のリクエストは、主任調査官によってケースバイケースで検討されます。

IPD 共有アクセス基準

データへのアクセスに関心のある研究者は、GAAIN を通じて要求を提出し、その後、主任研究者に提案書を提出するよう求められます。 提案には、所属機関、現在の履歴書または経歴、資金源 (該当する場合)、および研究課題と必要なデータの詳細な説明を含める必要があります。 また、すべての申請者は機密保持契約に署名する必要があります。 この契約は、個々の参加者の識別を可能にするような方法でのデータの使用を禁止します.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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