APOE 유전자형에 따른 신체활동, 알츠하이머병 및 인지 (PAAD-2)
2026년 8월 19일 업데이트: University of North Carolina, Greensboro
APOE 유전자형(PAAD-2)에 따른 신체 활동이 인지에 미치는 영향
신체 활동 및 알츠하이머병(PAAD-2)은 가족력으로 인해 알츠하이머병(AD)의 위험이 높은 중년(40-65세)인지 기능이 정상인 성인에 대한 운동의 효과를 평가하는 무작위 대조 시험입니다. (FH+).
조사관은 또한 이 효과가 APOE4(apolipoprotein epsilon-4) 보유자 상태에 의해 조절되는 정도를 평가하고 알츠하이머병의 위험이 가장 높은 사람의 인지 능력을 향상시키기 위해 신체 활동을 사용하는 것에 대한 중요한 새로운 실험적 증거를 수집할 것입니다. .
연구 개요
상세 설명
이 연구에서 연구자들은 신체 활동이 인지 성능 및 기본 메커니즘에 미치는 영향을 탐구하는 과거 연구에 대한 후속 조치를 취했습니다.
특히 연구자들은 알츠하이머병에 대한 개인의 유전적 위험의 함수로서 실현될 수 있는 잠재적으로 다른 효과에 관심을 가지고 있습니다.
이 연구에서 조사관은 다음과 같은 무작위 임상 시험을 제안하여 과거 작업을 확장합니다. 효과가 APOE4(apolipoprotein epsilon-4) 운반체 상태에 의해 조절되는지 확인합니다.
수사관은 대뇌 구조, 백질 무결성 및 휴식 상태 연결성에 대한 신경 영상 측정을 수집합니다. 추정되는 생물학적 지표를 평가합니다. 그리고 (조정된 중재 분석을 사용하여) 근본적인 메커니즘과 APOE4 캐리어 상태에 의해 영향이 조정되는 정도에 대한 이해를 높입니다.
가설을 테스트하기 위해 연구자들은 240명의 인지적으로 정상적인 중년 성인을 무작위로 1년 가상 신체 활동 프로그램 또는 일반적인 관리 통제에 할당합니다.
개입 대상자들은 1년 동안 스스로 수행하는 에어로빅 운동과 강사와 함께 가상 운동 세션에서 주도하는 저항 운동을 포함하여 1년 동안 신체 활동 프로그램에 참여하게 됩니다.
일상적인 관리 통제 조건에 있는 사람들은 1년 동안 정상적인 생활 방식을 유지하도록 요청받은 후 단기 피트니스 센터 회원권(테스트 세션 완료 시)을 받게 됩니다.
조사관은 사전, 중간 및 사후 테스트에서인지 성능을 평가하고 사전, 중간 및 사후 테스트에서 MRI 스캔 및 혈액 샘플을 얻습니다.
연구자들은 신체 활동이 인지 능력과 신경학적 및 생물학적 메커니즘에 미치는 영향을 조사하고 APOE4의 조절 역할을 탐구할 것입니다.
연구 유형
중재적
등록 (실제)
180
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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North Carolina
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Greensboro, North Carolina, 미국, 27402
- University of North Carolina-Greensboro
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
40년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
설명
포함 기준:
- 알츠하이머병 가족력, 인지장애
- 영어로 의사소통 가능
- 현재 신체 활동에 대한 권장 사항을 충족하지 못함(권장 사항은 3개월 이상 동안 매일 30분 이상 주 3일 운동하는 것임)
- 두 연구 조건 중 하나에 무작위 배정될 의향이 있음
- 1년 동안 모든 학습 활동을 완료할 의향이 있는 자
제외 기준:
- 임상 인지 장애 기준 충족
- 알려진 심혈관, 대사 또는 신장 질환으로 인해 신체 활동을 수행할 수 없으며 증상이 있거나 정형외과적 제한으로 인해
- 혼란스러운 신경학적, 정신과적 또는 활성 중증 또는 기능 장애 신경학적 또는 의학적 질병 또는 운동을 제한하거나 환자에게 위험을 초래할 수 있는 기타 조건의 자가 보고 병력
- 인지에 악영향을 미치거나 심박수에 영향을 미치는 알츠하이머병 증상을 치료하기 위한 약물의 현재 사용
- Center for Epidemiological Studies Depression Scale의 약식을 사용하여 우울증 기준을 충족하십시오.
- 연구 과정 중 장기간(>1개월) 여행
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 신체 활동 상태(PAC)
피험자는 1년 동안 주 3회 가상 운동 세션에 참석해야 합니다.
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피험자는 1년 동안 주 3회 가상 그룹 운동 세션에 참석합니다.
각 피험자는 안정시 HR 및 연령에 따라 적당한 강도(목표 심박수(HR)= 40-59% HR 예비)로 걸도록 권장됩니다.
피험자는 스스로 유산소 운동을 수행하고 저항 운동은 강사와 함께 가상 운동 세션에서 1년 동안 주 3일, 하루 1시간씩 완료합니다.
운동 세션에서 이 참가자들은 완료된 운동의 측정값을 기록하도록 요청받게 되며 심박수(20초 동안 촉진으로 평가) 및 인지된 노력(RPE)의 측정값을 제공하도록 요청받을 수 있습니다.
그들은 이 정보를 제공하는 운동 기록을 제출하라는 요청을 받을 것입니다.
운동 기록 및 운동 전문가 기록의 데이터는 진행의 증거, 적당한 강도의 일관된 달성, 유산소 및 근력 운동 구성 요소의 규정된 지속 시간과 관련하여 검토됩니다.
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간섭 없음: 일반 관리 제어(UCC)
일반 관리 제어 참가자는 1년 동안 정상적인 건강 관행을 유지합니다.
참가자는 격주로 건강 뉴스레터를 받게 되며 질문에 답하고 참가자의 건강에 대해 문의하기 위해 격주로 연락을 받을 것입니다.
참가자가 스스로 보고한 신체 활동은 매월 평가됩니다.
이런 방식으로 참가자들은 매주 직원들로부터 연락을 받게 됩니다.
사전, 중간 및 사후 테스트를 포함하여 모든 학습 관련 활동을 완료한 일반 케어 컨트롤 참가자는 사후 테스트 후 단기 YMCA 회원 자격을 받게 됩니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Performance on the Cognitive Domain of Executive Function as Measured With Stroop Interference Reaction Time (RT)
기간: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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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)
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Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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Change in Performance on the Cognitive Domain of Executive Function as Measured With Trail Making Test Interference
기간: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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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)
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Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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Change in Performance on the Cognitive Domain of Executive Function as Measured With NIH Toolbox Dimensional Change Card Sort
기간: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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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.
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Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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Change in Performance on the Cognitive Domain of Executive Function as Measured With the NIH Toolbox Flanker Test.
기간: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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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.
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Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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Change in Performance on the Cognitive Domain of Memory as Measured With the Auditory Verbal Learning Test.
기간: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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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.
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Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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Change in Performance on the Cognitive Domain of Memory as Measured With the Rey-Osterrieth Complex Figure Test
기간: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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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.
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Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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Change in Performance on the Cognitive Domain of Memory as Measured With the NIH Toolbox Picture Sequence Test
기간: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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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.
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Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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Change in Performance on the Cognitive Domain of Memory as Measured With the Mnemonic Similarity Test
기간: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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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.
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Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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Change in Performance on the Cognitive Domain of Attention as Measured With the Paced Auditory Serial Addition Test
기간: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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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.
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Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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Change in Performance on the Cognitive Domain of Attention as Measured With the Forward Digit Span Test
기간: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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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.
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Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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Change in Performance on the Cognitive Domain of Working Memory as Measured With NIH Toolbox List Sort Working Memory
기간: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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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.
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Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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Change in Performance on the Cognitive Domain of Working Memory as Measured With Spatial Working Memory
기간: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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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).
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Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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Change in Performance on the Cognitive Domain of Working Memory as Measured With Backward Digit Span
기간: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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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.
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Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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Change in Performance on the Cognitive Domain of Processing Speed as Measured With the Digit Symbol Modalities Test (SDMT)
기간: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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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.
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Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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Change in Performance on the Cognitive Domain of Processing Speed as Measured With the Stroop Word Test
기간: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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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)
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Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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Change in Performance on the Cognitive Domain of Processing Speed as Measured With the Stroop Color Test
기간: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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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)
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Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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Change in Performance on the Cognitive Domain of Processing Speed as Measured With the Trail Making Test A
기간: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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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)
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Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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Change in Performance on the Cognitive Domain of Executive Function as Measured With Matrix Reasoning.
기간: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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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.
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Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Brain Morphology (Whole Brain Volume)
기간: Pre-Test and Post-Test (~12 months)
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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.
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Pre-Test and Post-Test (~12 months)
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Change in Brain Morphology (Left Hippocampus Volume)
기간: Pre-Test and Post-Test (~12 months)
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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.
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Pre-Test and Post-Test (~12 months)
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Change in Brain Morphology (Right Hippocampus Volume)
기간: Pre-Test and Post-Test (~12 months)
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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.
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Pre-Test and Post-Test (~12 months)
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Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - BDNF
기간: Pre-Test and Post-Test (~12 months)
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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.
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Pre-Test and Post-Test (~12 months)
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Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - Irisin
기간: Pre-Test and Post-Test (~12 months)
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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.
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Pre-Test and Post-Test (~12 months)
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Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - IGF-1
기간: Pre-Test and Post-Test (~12 months)
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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)
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Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - Glucose
기간: Pre-Test and Post-Test (~12 months)
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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.
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Pre-Test and Post-Test (~12 months)
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Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - Insulin
기간: Pre-Test and Post-Test (~12 months)
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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.
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Pre-Test and Post-Test (~12 months)
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Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - TNFa
기간: Pre-Test and Post-Test (~12 months)
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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.
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Pre-Test and Post-Test (~12 months)
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Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - SAA
기간: Pre-Test and Post-Test (~12 months)
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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.
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Pre-Test and Post-Test (~12 months)
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Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - ALB
기간: Pre-Test and Post-Test (~12 months)
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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.
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Pre-Test and Post-Test (~12 months)
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Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - ApoE
기간: Pre-Test and Post-Test (~12 months)
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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.
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Pre-Test and Post-Test (~12 months)
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Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - ⍺-2 Macroglobulin
기간: 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.
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Pre-Test and Post-Test (~12 months)
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Change in Cardiorespiratory Fitness
기간: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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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.
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Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
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Change in Brain Activity (Resting-state Connectivity) Right Lateral Parietal, Posterior Cingulate Cortex
기간: Pre-Test and Post-Test (~12 months)
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Functional MRI will be used to measure brain activity including resting-state connectivity and change will be assessed from pre-test to post-test.
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Pre-Test and Post-Test (~12 months)
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Change in Brain Activity (Resting-state Connectivity) Left Lateral Parietal, Right Lateral Parietal
기간: Pre-Test and Post-Test (~12 months)
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Functional MRI will be used to measure brain activity including resting-state connectivity and change will be assessed from pre-test to post-test.
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Pre-Test and Post-Test (~12 months)
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Change in Brain Activity (Resting-state Connectivity) Left Lateral Parietal, Posterior Cingulate Cortex
기간: Pre-Test and Post-Test (~12 months)
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Functional MRI will be used to measure brain activity including resting-state connectivity and change will be assessed from pre-test to post-test.
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Pre-Test and Post-Test (~12 months)
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Change in Brain Activity (Resting-state Connectivity) Medial Prefrontal Cortex, Posterior Cingulate Cortex
기간: Pre-Test and Post-Test (~12 months)
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Functional MRI will be used to measure brain activity including resting-state connectivity and change will be assessed from pre-test to post-test.
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Pre-Test and Post-Test (~12 months)
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Change in Brain Activity (Resting-state Connectivity) Medial Prefrontal Cortex, Right Lateral Parietal
기간: Pre-Test and Post-Test (~12 months)
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Functional MRI will be used to measure brain activity including resting-state connectivity and change will be assessed from pre-test to post-test.
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Pre-Test and Post-Test (~12 months)
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Change in Brain Activity (Resting-state Connectivity) Medial Prefrontal Cortex, Left Lateral Parietal
기간: Pre-Test and Post-Test (~12 months)
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Functional MRI will be used to measure brain activity including resting-state connectivity and change will be assessed from pre-test to post-test.
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Pre-Test and Post-Test (~12 months)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Jennifer Etnier, PhD, UNC Greensboro
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Park KS, Etnier JL. An innovative protocol for the artificial speech-directed, contactless administration of laboratory-based comprehensive cognitive assessments: PAAD-2 trial management during the COVID-19 pandemic. Contemp Clin Trials. 2021 Aug;107:106500. doi: 10.1016/j.cct.2021.106500. Epub 2021 Jul 2.
- Park KS, Ganesh AB, Berry NT, Mobley YP, Karper WB, Labban JD, Wahlheim CN, Williams TM, Wideman L, Etnier JL. The effect of physical activity on cognition relative to APOE genotype (PAAD-2): study protocol for a phase II randomized control trial. BMC Neurol. 2020 Jun 6;20(1):231. doi: 10.1186/s12883-020-01732-1.
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 5월 23일
기본 완료 (실제)
2024년 12월 21일
연구 완료 (실제)
2024년 12월 21일
연구 등록 날짜
최초 제출
2019년 1월 24일
QC 기준을 충족하는 최초 제출
2019년 3월 12일
처음 게시됨 (실제)
2019년 3월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 19일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 18-0228
- R01AG058919 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
관련 법률 및 규정에 따라 공유를 위해 데이터 문서 및 비식별 데이터가 보관됩니다. 데이터는 비식별화된 익명 상태 및 .csv 형식으로 제공됩니다. 체재. 데이터는 RedCap에서 .csv로 내보내는 방식으로 공유됩니다. UNCG(University of North Carolina Greensboro) University Libraries 기관 리포지토리 North Carolina Digital Online Collection of Knowledge and Scholarship(NC DOCKS)과 함께 연구 주임 조사관의 기관 프로필에 보관된 파일입니다.
또한 이 데이터는 알츠하이머 관련 데이터에 관심이 있는 연구자를 위한 데이터 공유 및 협력 개발을 촉진하도록 설계된 연합 데이터 시스템인 GAAIN(Global Alzheimer's Association Interactive Network)을 통해 공유됩니다. 관심 있는 과학자는 PAAD-2 및 다른 연구의 메타 데이터를 탐색할 수 있습니다. 파트너가 되면 PAAD-2에 대한 설명과 책임 조사자에게 연락할 수 있는 링크가 www.gaain.org에서 제공됩니다.
IPD 공유 기간
알츠하이머 예방을 위한 협력(CAP)의 권장 사항에 따라 사전 무작위화 데이터는 등록 완료 후 12개월 이내에 보관됩니다.
NIH(National Institutes of Health) 지침에 따라 무작위 추출 후 데이터는 연구의 주요 결과(즉,
특정 목표와 관련된 결과) 또는 연구 종료 후 2년(둘 중 더 이른 시점).
엠바고 기간이 끝나기 전에 오는 데이터 공유 요청은 주임 조사관이 사례별로 고려합니다.
IPD 공유 액세스 기준
데이터에 액세스하는 데 관심이 있는 조사자는 GAAIN을 통해 요청을 제출한 다음 수석 조사자에게 제안서를 제출하도록 요청받을 것입니다.
제안서에는 기관 소속, 현재 이력서 또는 이력서, 자금 출처(해당되는 경우), 연구 질문 및 필요한 데이터에 대한 자세한 설명이 포함되어야 합니다.
또한 모든 지원자는 기밀 유지 동의서에 서명해야 합니다.
이 계약은 개인 참가자를 식별할 수 있는 방식으로 데이터를 사용하는 것을 금지합니다.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .