- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01555827
Retinal Neurodegenerative Signs in Alzheimer's Diseases (SIGNAL)
A few studies suggest that patients suffering from neurodegenerative diseases (such a multiple sclerosis or Alzheimer's disease (AD)) show decreased thickness of the retinal nerve fiber layer (RNFL), indicating axonal degeneration. High-definition spectral domain optical coherence tomography (SD-OCT), performed without radiation in a few seconds per eye, offers a precise and standardized estimation of this parameter, which could constitute a biomarker for cerebral axonal degeneration. These RNFL deficits might even be the earliest sign of AD, prior to damage of the hippocampal region that impacts memory.
Besides, some associations of AD with some degenerative diseases of the eye (glaucoma, microvascular abnormalities, age-related macular degeneration (AMD)) have also been reported.
It therefore seems interesting to determine whether RNFL thickness, and other ocular parameters, may give some indications for a better detection of AD and cognitive decline in the elderly.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Bordeaux, 프랑스, 33000
- CHU bordeaux - Hopital Pellegrin
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Inclusion criteria for AD cases:
- Diagnosis of probable AD, defined according to the NINCDS-ARDRA criteria51
- Light to moderate severity of the disease, defined by a MMSE score >10 (global evaluation of cognition)
- Patient aged 50 years or more
- Patient benefiting from social insurance
Inclusion criteria for controls:
- Absence of suspicion of dementia, based on normal performance according to age and educational level at neuropsychological testing defined as:
- Free recall ≥17 and total recall ≥40 for the Free and Cued Selective Reminding Test (Grober and Buschke test 52) MMSE ≥ norm for age and educational level (defined by mean - 1 SD)
- Isaac's set test ≥ norm for age and educational level (defined by mean - 1 SD)
- Matched to age and gender of the cases
- Patient benefiting from social insurance
Exclusion Criteria:
Exclusion criteria for all patients :
- History of Parkinson's disease or other neurodegenerative disorder
- History of Horton's disease
- History of inflammatory neuropathies (in particular Devic's disease, multiple sclerosis)
- History of vascular ischemic neuropathies and chronic intracranial hypertension
- History of pituitary tumors
- Presence of diseases (systemic and/or ocular diseases) or behavioural or cognitive symptoms incompatible with eye examination
- Known diabetes
- Person under tutorship or curatorship, person unable to express consent
Additional exclusion criteria for AD cases:
- Dementia of other cause than AD
- Severe AD, defined by MMSE score ≤ 10
Additional exclusion criteria for controls:
- Presence of dementia, of whatever cause
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 |
|---|---|
|
활성 비교기: 제어
|
The following examinations will be performed, after pupil dilation:
The following informations will be collected through a standardized questionnaire, administered face-to-face during the inclusion visit, or at the moment of the verification of eligibility criteria:
|
|
실험적: 알츠하이머병
|
The following examinations will be performed, after pupil dilation:
The following informations will be collected through a standardized questionnaire, administered face-to-face during the inclusion visit, or at the moment of the verification of eligibility criteria:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
RNFL thickness measured on a peri-papillary scan of SD-OCT examination.
기간: inclusion visit (day0)
|
inclusion visit (day0)
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Glaucomatous optic nerve damage observed on colour photographs (cup/disc ratio)
기간: inclusion visit (day0)
|
inclusion visit (day0)
|
|
Retinal microvascular abnormalities (microaneurysms, micro-hemorrhage, cotton wool spots, arteriovenous nicking), observed on retinal colour photography
기간: inclusion visit (day0)
|
inclusion visit (day0)
|
|
Macular abnormalities observed on retinal colour photographs (drusen, pigmentary abnormalities, neovascular AMD, atrophic AMD, other retinal diseases)
기간: inclusion visit (day0)
|
inclusion visit (day0)
|
|
Macular abnormalities observed on macular scans in SD-OCT (drusen, pigmentary abnormalities, neovascular AMD, atrophic AMD, epiretinal membranes, other retinal diseases).
기간: inclusion visit (day0)
|
inclusion visit (day0)
|
|
Macular abnormalities observed in autofluorescence imaging (increased autofluorescence, decreased autofluorescence, reticular drusen, atrophic AMD, other abnormalities)
기간: inclusion visit (day0)
|
inclusion visit (day0)
|
|
Macular and peripheral abnormalities diagnosed in wide-field retinal imaging
기간: inclusion visit (day0)
|
inclusion visit (day0)
|
|
Retinal blood flow velocity (RFI)
기간: inclusion visit (day0)
|
inclusion visit (day0)
|
|
Intraocular pressure
기간: inclusion visit (day0)
|
inclusion visit (day0)
|
|
axial length
기간: inclusion visit (day 0)
|
inclusion visit (day 0)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jean-François KOROBELNIK, Pr, University Hospital, Bordeaux, France
- 연구 의자: Delcourt Cécile, Dr, ISPED, bordeaux, France
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
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
- CHUBX2011/19
- 2011-A01219-32 (기타 식별자: ANSM)
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. .