Measurement of Retinal Nerve Fiber Layer Thickness - a Biomarker for the Early Detection of Alzheimer's Disease? (SCI-OCT)
|ClinicalTrials.gov Identifier: NCT02051244|
Recruitment Status : Unknown
Verified January 2014 by Carmel Medical Center.
Recruitment status was: Not yet recruiting
First Posted : January 31, 2014
Last Update Posted : January 31, 2014
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Observational Model:||Case Control|
|Official Title:||Pilot Study That Investigates the Potential of Using OCT (Optical Coherence Tomography) Measurements of the Thickness of the Retinal Nerve Fiber Layer as a Biomarker for the Early Detection of Alzheimer's Disease.|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||February 2015|
|Estimated Study Completion Date :||February 2015|
Subjective memory loss
Subjects who report memory loss, that may or may not be confirmed by an informant, but have normal cognitive tests ( MMSE scores of 27 or above out of 30. SLUMS scores of 20-30 for subjects with less than 8 years of education or 27-30 for those who have 12 or more years of education).
Mild Cognitive Impairment
Subjects with Mild Cognitive Impairment - defined as being problems with memory, language or another essential cognitive ability that are severe enough to show up on cognitive tests but not to interfere with daily life. MMSE score of 23-27 out of 30. SLUMS score of 16-19 for subjects with less than 8 years of education or 20-26 for those who have 12 or more years of education.
Subject who do not report memory loss and have normal cognitive tests. MMSE of 27 or above out of 30. SLUMS score of 20-30 for subjects with less than 8 years of education or 27-30 for those who have 12 or more years of education.
- Measurement of retinal nerve fiber layer thickness [ Time Frame: a once off measurement which will be performed within a year of recruitment to the study ]The subject will undergo a full eye examination including visual acuity, intraocular pressure and fundoscopy. This will be followed by an OCT test.
- Cognitive function [ Time Frame: a once off assessment that will be performed within a month of the opthalmic examination and OCT test. This will be completed within a year of recruitment to the study ]The subject will undergo the following cognitive tests - MMSE (Mini Mental State Examination) and SLUMS (St.Louis University Mental Status Examination).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051244
|Contact: Faith H Goldberg, MBBS||092 4 email@example.com|
|Carmel Medical Center||Not yet recruiting|
|Haifa, Israel, 34362|
|Principal Investigator: Faith H Goldberg, MBBS|
|Study Director:||Geyer Orna, MD||Professor of Ophthalmology Carmel Medical Center|