Trial record 18 of 21 for:    Open Studies | "Amnesia"

Measurement of Retinal Nerve Fiber Layer Thickness - a Biomarker for the Early Detection of Alzheimer's Disease? (SCI-OCT)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Carmel Medical Center
Sponsor:
Information provided by (Responsible Party):
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT02051244
First received: January 26, 2014
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to determine whether by measuring changes in the thickness of the retinal nerve fibre layer (the photosensitive layer at the back of the eye) you could predict if someone would develop Alzheimer's disease in the future. The measurement is made by OCT (ocular coherence tomography), a noninvasive and relatively inexpensive test that uses light waves to scan the back of the eye.


Condition
Alzheimer's Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
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.

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The subject will undergo a full eye examination including visual acuity, intraocular pressure and fundoscopy. This will be followed by an OCT test.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The subject will undergo the following cognitive tests - MMSE (Mini Mental State Examination) and SLUMS (St.Louis University Mental Status Examination).


Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
Control
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The subjects will be mainly recruited from the geriatric ward (patients, relatives, etc) and the cognitive clinic of the Carmel Medical Center.

Criteria

Inclusion Criteria:

  • age 60 and above
  • able to read, understand and sign independently a consent form
  • able to undergo a cognitive test
  • results of their cognitive test fall into one of the three cohort groups

Exclusion Criteria:

  • other diseases affecting the optic nerve such as glaucoma
  • unclear media such as dense cataracts that will not allow assessment by OCT
  • Cognitive test scores that are less than mild cognitive impairment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02051244

Contacts
Contact: Faith H Goldberg, MBBS 092 4 9832914 faith.goldberg@fosanet.org

Locations
Israel
Carmel Medical Center Not yet recruiting
Haifa, Israel, 34362
Principal Investigator: Faith H Goldberg, MBBS         
Sponsors and Collaborators
Carmel Medical Center
Investigators
Study Director: Geyer Orna, MD Professor of Ophthalmology Carmel Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Carmel Medical Center
ClinicalTrials.gov Identifier: NCT02051244     History of Changes
Other Study ID Numbers: CMC-13-0094-CTIL
Study First Received: January 26, 2014
Last Updated: January 30, 2014
Health Authority: Israel: Ethics Commission

Keywords provided by Carmel Medical Center:
Alzheimer's Disease
Retinal Nerve Fiber Layer
Ocular Computerized Tomography
Minimal Cognitive Impairment
Subjective Memory Loss
Asymptomatic Preclinical Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014