알츠하이머병 환자의 눈물에서 진단 바이오마커 식별: COG-EYE 파일럿 연구 (COG-EYE)
식별 De Biomarqueurs Diagnostiques Dans Les Larmes De Patients Atteints De Maladie D'Alzheimer : L'étude Pilote COG-EYE
The diagnosis of Alzheimer's disease (AD) relies on the detection of protein biomarkers, particularly in cerebrospinal fluid (e.g., Aβ and phosphorylated Tau) or through brain imaging. The invasive nature of lumbar puncture and the numerous contraindications have driven the search for early and reliable diagnostic biomarkers for AD.
Human tears are an accessible biological fluid that has proven relevant in the biomarker search strategy for both ophthalmological and systemic diseases, especially neurodegenerative conditions. Advances in methods for low-volume analysis have facilitated the identification of tear biomarkers. Total tau has been reported as elevated in the tears of patients with AD compared to controls (n=65). Additionally, metabo-lipidomic analyses offer several advantages (accessibility, non-invasiveness, reproducibility) and also appear promising as a diagnostic tool for systemic and neurodegenerative diseases, such as amyotrophic lateral sclerosis. This supports the relevance of comparing both AD proteins biomarkers and metabo-lipidomic signatures in the tears of patients with AD (Mild Cognitive Impairement (MCI) and dementia) with healthy controls.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Victoire LEROY, MD
- 전화번호: 0247477693
- 이메일: victoire.leroy@univ-tours.fr
연구 연락처 백업
- 이름: Raoul Kanav KHANNA, MD, PhD
- 이메일: raoul.khanna@univ-tours.fr
연구 장소
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France
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Tours, France, 프랑스, 37044
- 모병
- CHRU de Tours
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수석 연구원:
- Victoire LEROY, MD
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연락하다:
- Victoire LEROY
- 전화번호: +332 47 47 76 93
- 이메일: victoire.leroy@univ-tours.fr
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연락하다:
- Coralie TAILLEBUIS
- 전화번호: +332 47 47 39 09
- 이메일: cpcq@chu-tours.fr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age ≥18 years
- Participant affiliated in French Social Security scheme
- Informed and written consent from the participant
Exclusion Criteria:
- Pregnant or breastfeeding woman
- Participant under judicial protection measures
- Participant under guardianship or curatorship
- Contraindications to participation in the research:
Other neurodegenerative disease Any eye drops or treatment that may interfere with tear production Occasional or permanent contact lens use within the last 3 months Eye surgery ≤3 months Any ocular pathology other than refractive errors, oculomotor disorders, amblyopia Any general pathology other than AD with ocular implications
-Inability to perform tear collection
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Patients with AD dementia
Patient ≥ 18 years old with AD at a major stage according to the 2018 NIA-AA criteria (dementia) |
Collection of a tear volume of (i) 2 x 5µL using glass microcapillary tubes and (ii) 12µL using Schirmer strips after the instillation of anesthetic eye drops for metabo-lipidomic analysis and multiplexing of protein markers |
|
활성 비교기: Patients with AD Mild Cognitive Impaiment (MCI)
Patient ≥ 18 years old with AD at a minor stage according to the 2018 NIA-AA criteria (Mild Cognitive Impairment) |
Collection of a tear volume of (i) 2 x 5µL using glass microcapillary tubes and (ii) 12µL using Schirmer strips after the instillation of anesthetic eye drops for metabo-lipidomic analysis and multiplexing of protein markers Collection of a blood sample (5 mL) for blood biomarkers analysis. |
|
가짜 비교기: Healthy controls
Participants ≥ 18 years old with no known central neurological pathology, no cognitive decline, and matched by age (± 2 years) and sex with a patient from AD-MCI group |
Collection of a tear volume of (i) 2 x 5µL using glass microcapillary tubes and (ii) 12µL using Schirmer strips after the instillation of anesthetic eye drops for metabo-lipidomic analysis and multiplexing of protein markers |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Concentration of total Tau proteins in basal tears of patients with AD vs healthy volunteers
기간: At inclusion
|
12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest |
At inclusion
|
|
Concentration of phosphorylated Tau proteins in basal tears of patients with AD vs healthy volunteers
기간: At inclusion
|
12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest |
At inclusion
|
|
Concentration of Amyloid β 1-40 proteins in basal tears of patients with AD vs healthy volunteers
기간: At inclusion
|
12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest |
At inclusion
|
|
Concentration of Amyloid β 1-42 in basal tears of patients with AD vs healthy volunteers
기간: At inclusion
|
12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest |
At inclusion
|
|
Lipids in basal tears of patients with AD vs healthy volunteers
기간: At inclusion
|
Collection of tears (5μL) using a glass micropipette without local anaesthetic. Lipids in tears of patients with AD vs healthy volunteers |
At inclusion
|
|
Metabolites in basal tears of patients with AD vs healthy volunteers
기간: At inclusion
|
Collection of tears (5μL) using a glass micropipette without local anaesthetic. Metabolites in tears of patients with AD vs healthy volunteers |
At inclusion
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Concentration of total Tau proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
기간: At inclusion
|
12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest |
At inclusion
|
|
Concentration of phosphylated Tau proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
기간: A inclusion
|
12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest |
A inclusion
|
|
Concentration of Amyloid β 1-40 proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
기간: A inclusion
|
12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest |
A inclusion
|
|
Concentration of Amyloid β 1-42 proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
기간: A inclusion
|
12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest |
A inclusion
|
|
Lipids in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
기간: At inclusion
|
Collection of tears (5μL) using a glass micropipette without local anaesthetic. Identification of lipids in basal tears using liquid chromatography-mass spectrometry. |
At inclusion
|
|
Metabolites in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
기간: At inclusion
|
Collection of tears (5μL) using a glass micropipette without local anaesthetic. Identification of metabolites in basal tears using liquid chromatography-mass spectrometry. |
At inclusion
|
|
Concentration of total Tau proteins in basal tears of patients with AD-dementia vs patients with AD-MCI
기간: At inclusion
|
12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest |
At inclusion
|
|
Concentration of phosphorylated Tau proteins in basal tears of patients with AD-dementia vs patients with AD-MCI
기간: At inclusion
|
12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest |
At inclusion
|
|
Concentration of Amyloid β 1-40 proteins in basal tears of patients with AD-dementia vs patients with AD-MCI
기간: At inclusion
|
12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest |
At inclusion
|
|
Concentration of Amyloid β 1-42 proteins in basal tears of patients with AD-dementia vs patients with AD-MCI
기간: At inclusion
|
12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest |
At inclusion
|
|
Lipids in basal tears of patients with AD-dementia vs patients with AD-MCI
기간: At inclusion
|
Collection of tears (5μL) using a glass micropipette without local anaesthetic. Identification of lipids in basal tears using liquid chromatography-mass spectrometry. |
At inclusion
|
|
Metabolites in basal tears of patients with AD-dementia vs patients with AD-MCI
기간: At inclusion
|
Collection of tears (5μL) using a glass micropipette without local anaesthetic. Identification of metabolites in basal tears using liquid chromatography-mass spectrometry. |
At inclusion
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Victoire LEROY, MD, CHRU de Tours
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
- DR240140
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Qualified researchers may obtain access to all deidentified data in COG-EYE on a substantial request.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .