Chiaravalloti Nancy D, Weber Erica, Dobryakova Ekaterina, Lengenfelder Jean, Tong Tien T, Mulhauser Kyler, Moore Nancy B, Robinson Brionna, Maloku Diana, Salter Amber, Kanaan Nicholas M, Costa Silvana L, Hampstead Benjamin M
Center for Neuropsychology & Neuroscience Research, Kessler Foundation, East Hanover, NJ, USA; Department of Physical Medicine and Rehabilitation, Rutgers-NJ Medical School, Newark, NJ, USA.
Center for Neuropsychology & Neuroscience Research, Kessler Foundation, East Hanover, NJ, USA; Department of Physical Medicine and Rehabilitation, Rutgers-NJ Medical School, Newark, NJ, USA.
Contemp Clin Trials. 2025 Jun;153:107892. doi: 10.1016/j.cct.2025.107892. Epub 2025 Mar 29.
Long-term memory dysfunction is the hallmark feature of amnestic mild cognitive impairment (aMCI) resulting in substantial negative impact on everyday functioning and quality of life. The Kessler Foundation modified Story Memory Technique (KF-mSMT®) is a 10-session memory rehabilitation protocol in which participants are taught to utilize imagery and context to facilitate learning. This paper describes the protocol for a double blind, placebo controlled, randomized clinical trial (RCT) examining the efficacy of the KF-mSMT® in persons who meet criteria for aMCI.
Participants will undergo baseline assessments consisting of neuropsychological testing, neuroimaging, self-report questionnaires, and a blood draw for measuring plasma biomarkers. Participants will then be randomized to one of two conditions using concealed allocation: KF-mSMT® or an active placebo control condition consisting of memory exercises. Participants will be blinded to condition. Within 2 weeks of completing the intervention, participants will complete the same measures as at baseline administered by treatment-blinded assessors. The primary study outcome is new learning and memory measured by neuropsychological assessment (Open Trial Selective Reminding Test). Secondary outcomes include other measures of learning and memory (i.e. Repeatable Battery for the Assessment of Neuropsychological Status story), visuospatial memory (Brief Visuospatial Memory Test-Revised)) as well as everyday memory (Ecological Memory Simulations, Object Location Touchscreen Test), neuroimaging and plasma biomarkers.
If successful, this trial will provide Class I evidence supporting the application of the KF-mSMT® for treating MCI-related learning and memory decline in older adults.
长期记忆功能障碍是遗忘型轻度认知障碍（aMCI）的标志性特征，会对日常功能和生活质量产生重大负面影响。凯斯勒基金会改良故事记忆技术（KF-mSMT®）是一种为期10节的记忆康复方案，其中会教导参与者利用意象和情境来促进学习。本文描述了一项双盲、安慰剂对照、随机临床试验（RCT）的方案，该试验旨在检验KF-mSMT®对符合aMCI标准的人群的疗效。
参与者将接受基线评估，包括神经心理学测试、神经影像学检查、自我报告问卷以及用于测量血浆生物标志物的血液抽取。然后，参与者将使用隐蔽分配随机分为两种情况之一：KF-mSMT®或由记忆练习组成的活性安慰剂对照情况。参与者将对分组情况不知情。在完成干预的2周内，参与者将由对治疗不知情的评估人员完成与基线相同的测量。主要研究结果是通过神经心理学评估（开放试验选择性提醒测试）测量的新学习和记忆。次要结果包括其他学习和记忆测量指标（即用于评估神经心理状态故事的可重复成套测验）、视觉空间记忆（简短视觉空间记忆测试修订版）以及日常记忆（生态记忆模拟、物体位置触摸屏测试）、神经影像学和血浆生物标志物。
如果试验成功，本试验将提供I类证据，支持应用KF-mSMT®治疗老年人中与MCI相关的学习和记忆衰退。
