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Идёт набор NCT03233646

Retinal Imaging in Neurodegenerative Disease

— Наблюдательное Alzheimer's Disease Mild Cognitive Impairment Parkinson's Disease Multiple Sclerosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Retinal and Choroidal Imaging.
Кому может быть актуально
Состояния в реестре: Alzheimer's Disease, Mild Cognitive Impairment, Parkinson's Disease, Multiple Sclerosis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluating the Retinal and Choroidal Microvasculature and Structure Using Multimodal Retinal and Choroidal Imaging in Neurodegenerative Disease: iMIND Research Study

Обзор

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.

Подробное описание

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.

The 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.

This 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.

The protocol for this study was amended and the record was updated accordingly.

Вмешательства

  • Устройство Retinal and Choroidal Imaging
    Non-invasive OCT, OCTA, and UWF fundus photography of retina

Первичные конечные точки

  • Change in ganglion cell-inner plexiform layer (GCIPL) thickness [Срок оценки: Baseline, 1 year]
  • Change in retinal nerve fiber layer (RNFL) thickness [Срок оценки: Baseline, 1 year]
  • Change in central subfield thickness (CST) [Срок оценки: Baseline, 1 year]
  • Change in choroidal vascularity index (CVI) [Срок оценки: Baseline, 1 year]
  • Change in foveal avascular zone (FAZ) area [Срок оценки: Baseline, 1 year]
  • Change in average perfusion density (PD) [Срок оценки: Baseline, 1 year]
  • Change in average vessel density (VD) [Срок оценки: Baseline, 1 year]
  • Change in average capillary perfusion density (CPD) [Срок оценки: Baseline, 1 year]
  • Change in average capillary flux index (CFI) [Срок оценки: Baseline, 1 year]
Вторичные конечные точки (3)
  • Change in retinal vessel tortuosity [Срок оценки: Baseline, 1 year]
  • Change in retinal vessel width gradient [Срок оценки: Baseline, 1 year]
  • Change in retinal vessel fractal dimension [Срок оценки: Baseline, 1 year]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

If 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 1 центр
  • Duke University Medical Center — Durham

Публикации

  • 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/s12886-025-04157-x. PMID 40598011
  • 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/IAE.0000000000003458. PMID 35723922

Идентификаторы

NCT: NCT03233646 · Pro00111831

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗