Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 6:08 AM
Study NCT ID:
NCT07254234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Retinal Imaging to Detect Abnormal Protein Deposits Associated With Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D008569', 'term': 'Memory Disorders'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-11-20', 'studyFirstSubmitQcDate': '2025-11-20', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants with the Same Results on the Blood Test and Retinal Scan', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants who Report High or Moderate Satisfaction with Retinal Scan', 'timeFrame': 'Day 1', 'description': 'Measured by 5-item retinal scan feedback survey. Participants rate their experience with the retinal scan on a 5-item Likert scale that ranges from "Strongly Disagree" to "Strongly Agree." Higher scores are better.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Dysfunction', 'Memory Disorders']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to test the use of a screening tool to detect changes in the eye that are associated with Alzheimer's disease in adult participants with memory issues. For each participant, the study will last up to one month and requires one visit to the research site."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Emiratis age 55 or older with mild memory complaints or MCI who are otherwise healthy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who are overtly healthy as determined by medical evaluation, including medical history and physical examination.\n* Have mild memory complaints or a diagnosis of mild cognitive impairment.\n* Have undergone genotyping for apolipoprotein E (APOE) and are willing to make results available to the investigator.\n* Montreal Cognitive Assessment (MoCA) score of greater than or equal to 22 and less than or equal to 28.\n\nExclusion Criteria:\n\n* Have any medical condition that, in the opinion of the investigator, would be a contraindication to participation in the study.\n* Have an existing diagnosis of AD or other dementia.\n* Have contradictions to or an allergy to the ophthalmic dilating agents.\n* Have known diagnosis of severe glaucoma or severe cataracts; have a significant refractive error (more than 12 diopters \\[D\\] of spherical equivalent refraction); or have any ocular media opacity that prevents imaging of the retina (that is, severe cataract). Note: mild to moderate cataracts or vision correction with glasses or contact lenses are not exclusion criteria.\n* Current or previous treatment with anti-amyloid medications.\n* Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.'}, 'identificationModule': {'nctId': 'NCT07254234', 'briefTitle': "A Study of Retinal Imaging to Detect Abnormal Protein Deposits Associated With Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Exploratory Study to Assess Utility of RetiSpec Artificial Intelligence Powered Retinal Imaging Solution in Detecting Amyloid Pathology in United Arab Emirates Nationals With Mild Impairment of Cognition', 'orgStudyIdInfo': {'id': '27414'}, 'secondaryIdInfos': [{'id': 'H7I-MC-S035', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with Memory Complaints or Mild Cognitive Impairment (MCI)', 'description': 'Retinal scan and blood biomarker testing', 'interventionNames': ['Other: Retinal scan', 'Other: Blood test']}], 'interventions': [{'name': 'Retinal scan', 'type': 'OTHER', 'description': 'Detailed image of the retina.', 'armGroupLabels': ['Participants with Memory Complaints or Mild Cognitive Impairment (MCI)']}, {'name': 'Blood test', 'type': 'OTHER', 'description': "Sample will be used to test for a specific form of a protein in the blood to learn more about early detection of Alzheimer's disease.", 'armGroupLabels': ['Participants with Memory Complaints or Mild Cognitive Impairment (MCI)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abu Dhabi', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Usman Moghal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cleveland Clinic Abu Dhabi', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'centralContacts': [{'name': 'Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or', 'role': 'CONTACT', 'email': 'LillyTrials@Lilly.com', 'phone': '1-317-615-4559'}, {'name': 'Physicians interested in becoming principal investigators please contact', 'role': 'CONTACT', 'email': 'clinical_inquiry_hub@lilly.com'}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}