Longitudinal Profiling of Plasma-Derived Glial Extracellular Vesicles in Alzheimer's Disease (GLEVAD)
Longitudinal Profiling of Plasma-Derived Glial Extracellular Vesicles in Alzheimer's Disease: A Focus on the Role of Neuroinflammation and Its Implication for Disease Progression
연구 개요
상세 설명
The primary goal of the project is to longitudinally profile plasma-derived GDEVs and neuroinflammation biomarkers to better understand their role in AD progression and to investigate novel, non-invasive blood-based biomarkers for improved diagnosis, prognosis, and disease monitoring.
The study will focus on key stages of the AD continuum, investigating the relationship between neuroinflammation and established indicators of core AD pathology, cognitive decline, and clinical progression over time.
An innovative dual translational approach will test the effects of disease-stage-specific GDEVs on healthy human iPSC-derived neurons, assessing their neurotoxic or priming effects and revealing their direct biological impact. This combined approach aims to identify early neuroinflammation signatures and investigate novel diagnostics and therapeutic targets.
A multidisciplinary approach will be adopted to achieve the following four objectives:
Objective 1: To profile changes in plasma-derived GDEV cargo and neuroinflammation biomarkers across the AD continuum, from cognitively normal individuals to those with SCD-AD, MCI-AD and Dem-AD.
Objective 2: To investigate the relationship between GDEVs/neuroinflammation biomarkers and fluid biomarkers of amyloidopathy, tauopathy, and neurodegeneration.
Objective 3: To assess their association with clinical and cognitive markers of AD progression, identifying biological profiles predictive of cognitive decline and clinical progression rate.
Objective 4: To assess the neurotoxic or priming effects of GDEVs from different disease stages on human iPSC-derived neurons from healthy subjects.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Guido Maria Giuffrè, PhD
- 전화번호: +390630157936
- 이메일: guidomaria.giuffre@policlinicogemelli.it
연구 장소
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Rome, 이탈리아, 00168
- 모병
- Fondazione Policlinico Agostino Gemelli IRCCS
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연락하다:
- Guido Maria Giuffrè, PhD
- 전화번호: +390630154333
- 이메일: guidomaria.giuffre@policlinicogemelli.it
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- For Ctrl: Individuals with no subjective or objective cognitive complaints, normal performance on standardized neuropsychological assessments, and normal AD biomarkers.
- For SCD-AD: Individuals reporting persistent self-perceived cognitive decline in the absence of objective cognitive impairment on standardized neuropsychological assessments and with preserved functional independence in activities of daily life, with abnormal AD biomarkers
- For MCI-AD: Individuals showing evidence of persistent cognitive decline, either self-reported or observed by an informant, with objective cognitive impairment on standardized neuropsychological assessments and with preserved independence in daily activities, with abnormal AD biomarkers
- For Dem-AD: Individuals with substantial progressive cognitive impairment affecting multiple domains and/or associated neuropsychiatric symptoms, confirmed by objective cognitive impairment on standardized neuropsychological assessments and a clear functional decline impacting independence, abnormal AD biomarkers
- For all subjects: Informed consent form signed by subject or caregiver
Exclusion Criteria:
- Exclusion criteria will be age <55 or >80 years, lack of a reliable study partner, previous or concomitant neurological diseases, major psychiatric disorders, medical conditions potentially able to interfere with cognitive functions, previous participation in experimental studies with amyloid targeting agents, significant systemic inflammatory diseases or use of immunosuppressive medication.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: Single Arm
single arm
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blood sampling for plasma biomarkers analyses
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Longitudinal changes
기간: 24 months
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Longitudinal changes in plasma-derived GDEV cargo and neuroinflammation biomarkers across the Alzheimer's disease continuum
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24 months
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Disease-stage-specific molecular signatures
기간: 24 months
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Identification of disease-stage-specific GDEV molecular signatures associated with progression along the AD continuum
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24 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Associations between biomarkers
기간: 24 months
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Identification of associations between GDEV/neuroinflammation biomarkers and established fluid biomarkers of amyloidopathy, tauopathy and neurodegeneration
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24 months
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Relationships with Clinical Measures
기간: 24 months
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Evaluation of the rate of correlations between plasma GDEV profiles and clinical measures of disease severity, including global cognitive performance, domain-specific cognitive decline, functional impairment and clinical staging (evalauted through neuropsychological assessments and clinical scales)
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24 months
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Predictive Value
기간: 24 months
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Exploration of the predictive value of baseline and longitudinal GDEV/neuroinflammation profiles in predicting clinical progression along the AD continuum
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24 months
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Neurotoxic or priming effects
기간: 24 months
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Assessment of the prevalence of neurotoxic or priming effects of GDEVs from different disease stages on human iPSC-derived neurons from healthy subjects, comparing the biological effects of GDEVs across disease stages
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24 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Giudo Maria Giuffrè, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 27072
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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