Personalized Medicine in the Elderly With Vision Impairment and Mild Cognitive Impairment

Официальное название

Personalized Medicine in the Elderly With Vision Impairment and Mild Cognitive Impairment: Effects of Sensorineural Telerahabilitation

Обзор

Globally, approximately 55 million people suffer from dementia, and 60-70% of cases are due to Alzheimer's disease (AD). Increasing scientific evidence highlights that the pathological changes underlying AD and other forms of dementia begin long before the onset of symptoms. Mild cognitive impairment (MCI) is a clinical condition that in people over 65 shows a prevalence ranging from 3% to 22%. The characteristics of MCI are the presence of a subjective memory disorder and a reduced ability to learn new information with normal general cognitive functioning, normal ability to perform daily activities and the absence of other conditions, such as depression, that could justify the memory disorder. Currently, the diagnosis of MCI is based exclusively on clinical evaluation, including neuropsychological tests. Currently, there are no therapies available to prevent and/or treat dementia and the options for intervention are represented by treatments such as physical exercise and cognitive treatment. These practices refer to the concept of cognitive reserve. Computerized cognitive training (CCT) is characterized by being a personalized intervention, allows multi-domain training and increases the cognitive processes of patients with MCI. The National Low Vision Center has been using a software called nLIFE EyeFitness for several years, certified as a Class I Medical device. It allows you to carry out individualized rehabilitation exercises at home, using your own PC or tablet, with monitoring by the Center's operators. The exercises currently present stimulate attention, short-term visual memory, reaction time, executive function, working memory and, therefore, also appear suitable for stimulating subjects with MCI.

Вмешательства

• Устройство nLIFE EyeFitness
  A software called nLIFE EyeFitness, certified as a Class I Medical device, allows to carry out individualized rehabilitation exercises at home, using own PC or tablet, with monitoring by the Center's operators.

Первичные конечные точки

• The effects of neurosensory telerehabilitation in elderly subjects with MCI [Срок оценки: 8 months]

Вторичные конечные точки (1)

• Evaluation the effects of neurosensory telerehabilitation on visual tests score [Срок оценки: 8 months]

Критерии участия

Критерии включения

• Patients aged ≥ 60 years with a diagnosis of aMCI
• Signing of informed consent

Критерии исключения

• Age <60 years
• History of dementia
• Diabetes mellitus
• Uncontrolled hypertension
• Diagnosis of major depression
• Glaucoma
• Age-related macular degeneration
• Media opacity and vitreoretinal pathologies that may preclude a correct evaluation
• • Failure to obtain informed consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Италия · 1 центр

• Fondazione Policlinico Universitario A. Gemelli IRCCS, Polo Nazionale Ipovisione — Rome

Идентификаторы

NCT: NCT06942728 · 5032

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗