Improve New Learning and Memory in Individuals With Mild Cognitive Impairment

Официальное название

Use of a Memory Technique to Improve New Learning and Memory in Individuals With Mild Cognitive Impairment

Обзор

The current study is a double-blind, placebo-control randomized clinical trial examining the efficacy of memory retraining in individuals with Mild Cognitive Impairment (MCI). Impairment in higher level cognitive processing, such as new learning and memory, is one of the most common deficits in individuals with MCI and such deficits have been shown to exert significant negative impact on multiple aspects of everyday life, including occupational and social functioning. Despite these findings, few studies have attempted to treat these cognitive deficits in order to improve the everyday functioning of individuals with MCI. Through a small randomized clinical trial, the investigators found that individuals with MCI with documented cognitive impairment show a significant improvement in their memory performance following a treatment protocol designed to facilitate learning. The current proposal will replicate this finding and further evaluate (a) the impact of the treatment on everyday functioning, (b) the long term efficacy of the treatment and (c) the utility of booster sessions in facilitating long-term treatment effects. We will randomly assign older individuals who meet criteria for a diagnosis of amnestic MCI to a memory retraining group or a placebo control group. Both groups will undergo baseline, immediate and long-term follow-up assessment consisting of: (1) a traditional neuropsychological battery, (2) an assessment of global functioning examining the impact of the treatment on daily activities, and (3) functional neuroimaging. This design will allow the investigators to evaluate the efficacy of this particular memory retraining technique in an aMCI population through the assessment of cognitive function via a standard evaluation. In addition, the investigators will be able to draw conclusions regarding the impact of this particular memory remediation program on everyday life from questionnaires completed by the participant and a significant other. Optional enrollment in pre- post neuroimaging will also allow the investigators to look at changes in the brain.

Вмешательства

• Поведенческое Memory Retraining Exercises
  Memory retraining exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).
• Поведенческое Placebo Control Memory Exercises
  Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).

Первичные конечные точки

• Verbal list learning [Срок оценки: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed]
• Participation in everyday life [Срок оценки: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed]

Вторичные конечные точки (8)

• Self-reported depression [Срок оценки: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed]
• Self-reported anxiety [Срок оценки: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed]
• Self-reported quality of life [Срок оценки: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed]
• Self-reported quality of well-being [Срок оценки: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed]
• Functional neuroimaging [Срок оценки: two points in time: pre-treatment and immediately following treatment]
• Functional memory [Срок оценки: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed]
• Functional memory [Срок оценки: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed]
• Story memory [Срок оценки: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed]

Критерии участия

Критерии включения

• 60 or older.
• read and speak English fluently.
• Research based diagnosis of Amnestic Mild Cognitive Impairment

Критерии исключения

• prior stroke or neurological injury/disease (i.e. traumatic brain injury, Multiple Sclerosis, or Stroke).
• history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis).
• significant alcohol or drug abuse history (inpatient treatment).
• Benzodiazepines and steroid use

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

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• University of Michigan — Ann Arbor
• Kessler Foundation Research Center — West Orange

Идентификаторы

NCT: NCT05396248 · R-1183-22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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