[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03233646":3,"trial-entities:NCT03233646":145,"trial-summary:NCT03233646":154},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":34,"study_type":46,"primary_purpose":47,"phases":48,"enrollment_info":49,"interventions":52,"primary_outcomes":60,"secondary_outcomes":89,"sex":99,"minimum_age":100,"maximum_age":47,"healthy_volunteers":101,"eligibility_criteria":102,"std_ages":110,"locations":113,"central_contacts":129,"overall_officials":131,"references":136,"see_also_links":144},"NCT03233646","Pro00111831","Retinal Imaging in Neurodegenerative Disease","Evaluating the Retinal and Choroidal Microvasculature and Structure Using Multimodal Retinal and Choroidal Imaging in Neurodegenerative Disease: iMIND Research Study","RECRUITING","2026-12-31","2026-02","2026-02-04","2017-07-20","Duke University","OTHER",false,"This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), Parkinson's Disease (PD), or other neurodegenerative disease, diseases as outlined.","Using a multidisciplinary approach, this study aims to yield new insight into the vascular and structural pathophysiology of neurodegenerative disease. The investigators propose to develop and evaluate imaging biomarkers from OCT, OCTA, and UWF fundus photos to assess the structure and function of the retinal and choroidal microvasculature and structure in these individuals.\n\nThe investigators hypothesize that microvascular and structural network alterations in the retina and choroid may mirror and possibly precede changes in the cerebral microcirculation seen in these neurodegenerative diseases. Using advanced image analysis and machine learning techniques, the investigators aim to evaluate markers of reduced capillary blood flow and non-perfusion in the superficial retinal vascular plexus and choriocapillaris imaged using OCT and OCTA, in a resolution not previously possible, that would complement already established retinal structural markers and increase their sensitivity and specificity in the earlier detection of these neurodegenerative diseases.\n\nThis study looks to provide a proof of concept for retinal and choroidal imaging-based microvascular and structural biomarkers as an effective screening tool for neurodegenerative disease, particularly during in cognitive aging.\n\nThe protocol for this study was amended and the record was updated accordingly.",[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33],"Alzheimer's Disease","Mild Cognitive Impairment","Parkinson's Disease","Multiple Sclerosis","Huntington Disease","Lewy Body Dementia","Frontotemporal Dementia","Amyotrophic Lateral Sclerosis (ALS)","APOE-4 Positive","Traumatic Brain Injury","Concussion","Post-Traumatic Stress Disorder","Down Syndrome","Neuro-Degenerative Disease","Normal Cognition",[35,36,37,38,39,40,41,42,43,44,45],"OCT angiography (OCTA)","Optical Coherence Tomography (OCT)","Vessel Density","Superficial Capillary Plexus","Retinal microvasculature","Scanning Laser Ophthalmoscopy","Ultra-widefield (UWF) Imaging","Perfusion Density","Retinal Nerve Fiber Layer","Ganglion Cell Inner Plexiform Layer","Choroidal Vascularity Index","OBSERVATIONAL",null,[],{"count":50,"type":51},2000,"ESTIMATED",[53],{"type":54,"name":55,"description":56,"armGroupLabels":57},"DEVICE","Retinal and Choroidal Imaging","Non-invasive OCT, OCTA, and UWF fundus photography of retina",[58,59],"Case","Controls",[61,65,68,71,74,77,80,83,86],{"measure":62,"description":63,"timeFrame":64},"Change in ganglion cell-inner plexiform layer (GCIPL) thickness","Ganglion cell inner plexiform layer thickness as measured on optical coherence tomography scan of macula","Baseline, 1 year",{"measure":66,"description":67,"timeFrame":64},"Change in retinal nerve fiber layer (RNFL) thickness","Retinal nerve fiber layer thickness as measured on optical coherence tomography scan of macula",{"measure":69,"description":70,"timeFrame":64},"Change in central subfield thickness (CST)","Central subfield thickness as measured on optical coherence tomography scan of macula",{"measure":72,"description":73,"timeFrame":64},"Change in choroidal vascularity index (CVI)","Choroidal vascularity index as measured using the COIN software in 1500 um area centered on the fovea",{"measure":75,"description":76,"timeFrame":64},"Change in foveal avascular zone (FAZ) area","Foveal avascular zone area as measured in the superficial capillary plexus on 3mm optical coherence tomography angiography scan of the macula",{"measure":78,"description":79,"timeFrame":64},"Change in average perfusion density (PD)","Average perfusion density as measured in the ETDRS 3mm and 6mm circle and rings on optical coherence tomography angiography scan of the macula",{"measure":81,"description":82,"timeFrame":64},"Change in average vessel density (VD)","Average vessel density as measured in the ETDRS 3mm and 6mm circle and rings on optical coherence tomography angiography scan of the macula",{"measure":84,"description":85,"timeFrame":64},"Change in average capillary perfusion density (CPD)","Capillary perfusion density as measured on peripapillary 4.5mm optical coherence tomography angiography scan",{"measure":87,"description":88,"timeFrame":64},"Change in average capillary flux index (CFI)","Capillary flux index as measured on peripapillary 4.5mm optical coherence tomography angiography scan",[90,93,96],{"measure":91,"description":92,"timeFrame":64},"Change in retinal vessel tortuosity","Retinal vessel tortuosity measured on ultra-widefield scanning laser ophthalmoscopy image using VAMPIRE software",{"measure":94,"description":95,"timeFrame":64},"Change in retinal vessel width gradient","Retinal vessel width gradient measured on ultra-widefield scanning laser ophthalmoscopy image using VAMPIRE software",{"measure":97,"description":98,"timeFrame":64},"Change in retinal vessel fractal dimension","Retinal vessel fractal dimension measured on ultra-widefield scanning laser ophthalmoscopy image using VAMPIRE software","ALL","18 Years",true,{"inclusion":103,"exclusion":106,"raw_text":109},[104,105],"Adults with neurodegenerative disease ((MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)","Adults without neurodegenerative disease",[107,108],"Inability to cooperate with or complete testing or other neurologic or age- related ocular conditions that would impact image acquisition.","Eyes that have had intraocular surgery, other than cataract surgery.","Inclusion Criteria:\n\n* Adults with neurodegenerative disease ((MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)\n* Adults without neurodegenerative disease\n\nExclusion Criteria:\n\n* Inability to cooperate with or complete testing or other neurologic or age- related ocular conditions that would impact image acquisition.\n* Eyes that have had intraocular surgery, other than cataract surgery.\n\nIf two eyes satisfy the inclusion criteria, both eyes will be included in the study. If one eye satisfies the inclusion criteria, the eye that qualifies will be included in the study.",[111,112],"ADULT","OLDER_ADULT",[114],{"facility":115,"status":8,"city":116,"state":117,"zip":118,"country":119,"contacts":120,"geoPoint":126},"Duke University Medical Center","Durham","North Carolina","27705","United States",[121],{"name":122,"role":123,"phone":124,"email":125},"Sharon Fekrat, MD FACS FASRS","CONTACT","919-681-3937","imind@duke.edu",{"lat":127,"lon":128},35.99403,-78.89862,[130],{"name":122,"role":123,"phone":124,"email":125},[132,134],{"name":122,"affiliation":13,"role":133},"PRINCIPAL_INVESTIGATOR",{"name":135,"affiliation":13,"role":133},"Dilraj Grewal, MD",[137,141],{"pmid":138,"type":139,"citation":140},"40598011","DERIVED","Zhao W, Robbins CB, Grewal DS, Patel H, Soundararajan S, Liu AJ, Johnson KG, Agrawal R, Petrella JR, Stinnett SS, Parker D, Fekrat S. Correlating retinal and choroidal vascular parameters with volumetric MRI in Alzheimer's disease and amnestic mild cognitive impairment. BMC Ophthalmol. 2025 Jul 1;25(1):365. doi: 10.1186\u002Fs12886-025-04157-x.",{"pmid":142,"type":139,"citation":143},"35723922","Robbins CB, Akrobetu D, Ma JP, Stinnett SS, Soundararajan S, Liu AJ, Johnson KG, Grewal DS, Fekrat S. ASSESSMENT OF RETINAL MICROVASCULAR ALTERATIONS IN INDIVIDUALS WITH AMNESTIC AND NONAMNESTIC MILD COGNITIVE IMPAIRMENT USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2022 Jul 1;42(7):1338-1346. doi: 10.1097\u002FIAE.0000000000003458.",[],{"nct_id":4,"conditions":146,"biomarkers":153},[19,147,29,148,31,25,149,24,150,22,151,30,152],"Amyotrophic Lateral Sclerosis","Degenerative Disease of Nervous System, Unspecified","Huntington's Disease","Mild cognitive disorder","Parkinson Disease","Traumatic Encephalopathy",[],{"nct_id":4,"found":101,"summary":155,"prompt_version":164},{"design":156,"status":157,"heading":6,"summary":158,"follow_up":159,"word_count":160,"commitments":161,"compensation":162,"drugs_mentioned":163},"This is an observational study with a planned enrollment of 2000 participants. It is not specified if it is randomized or blinded.","completed","This observational study is looking at how non-invasive eye scans, called Optical Coherence Tomography (OCT), OCT Angiography (OCTA), and ultra-widefield (UWF) fundus photography, can help us understand conditions like Alzheimer's Disease, Parkinson's Disease, and Multiple Sclerosis. These scans look at the tiny blood vessels and structures in the back of your eye (retina and choroid). Researchers believe changes in your eyes might show what's happening in your brain. They will measure changes in specific layers of your retina (GCIPL, RNFL, and CST) over one year. You can join if you are an adult with or without a neurodegenerative disease, as long as you can cooperate with the eye tests. The study aims to see if these eye scans can be a useful tool for early detection of these diseases.","Participants will be followed for one year, with measurements taken at baseline and at the one-year mark.",129,"You would undergo non-invasive OCT, OCTA, and UWF fundus photography of your retina at the start of the study and again after one year.","Not stated in the trial record.",[],"v2"]