Behavioral Intervention Development Core - Long Term Memory Digital Intervention in Aging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- MDT change in recognition memory
研究概览
简要总结
Healthy aging is typically accompanied by diminished capability for learning and retrieval of high-fidelity long-term memory (LTM). The decline in these faculties is accelerated and becomes significant deficits in LTM and cognitive control functions at the level or a diagnosis of Mild Cognitive Impairment (MCI). Training with the navigation game, relative to training with control games, is expected to improve LTM performance for older adult participants.
Researchers will compare two different digital interventions to assess whether they may be helpful in improving cognitive function.
Participants will conduct study activities remotely (e.g., at-home):
- Baseline Assessment. Complete a series of cognitive assessments and surveys.
- Intervention. Engage in a digital intervention for up to 8 weeks.
- Post Intervention Assessment. Complete the same cognitive assessments and surveys as the Baseline Assessment.
- Follow-Up Assessment. Six months after the intervention ends, participants will complete the same cognitive assessments and surveys as the Baseline Assessment.
详细描述
Older adult participants consent and enroll in the LTM Digital Intervention, which is a randomized control trial (RCT) administered on the Neuroscape Nexus web-based research platform. Enrolled participants are randomly assigned to either of two arms that will play memory-based games.
Participants are provided by the study team with an Apple iPad 10th Generation (2024) at their home address, which will enable them to complete all study tasks at home via Nexus. All required applications will be pre-loaded on the device.
Participants will receive notifications and reminders to complete study tasks by email, through in-app reminders, or SMS. They can view their task list and progress in their personal dashboard in Nexus.
Study procedures include a series of surveys and brief tests of memory and attention as Baseline Tests, which make take up to 120 minutes and can be completed across more than one session.
Participants will engage with their assigned training application to complete 45 minutes of training, several days a week for up to 8 weeks for a total of 1000 minutes of training. Participants will be randomly assigned to one of two intervention apps, which encourage long-term memory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
After recruitment, participants are randomly assigned to one of two arms, Participants and experimenters with whom they interact during the experiment are blind to treatment purpose of the randomly-assigned arm. First-level analysis of the data (baseline, post training and follow up) performed blind to the participant's arm.
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum of 12 years of education
- •English fluency: All task instructions are presented in English language text. In order to control for sufficient and equivalent participant comprehension of the procedures and instructions, we require their self-report of fluency in English.
- •Normal or corrected-to-normal vision
- •Normal or corrected-to-normal hearing
- •Medically healthy older adults, including those with below-average cognitive performance /MCI patients without dementia referred by neuropsychologists (i.e., no participant medical records will be reviewed).
排除标准
- •Under the age of 60
- •Clinical diagnosis of neurological or psychiatric disorder Clinical diagnosis of dementia or AD8 score of >4
- •Visually or hearing impaired without correction to normal
- •Regularly (one or more times per week) practicing an instrument within the last year
- •10 years or more of formal musical instrument training
研究组 & 干预措施
Long Term Memory
Multi-session cognitive intervention as a computer game that presents an adaptive spatial wayfinding challenge.
干预措施: Long Term Memory (Behavioral)
Worder
Multi-session cognitive intervention as a computer game that presents a word puzzle.
干预措施: Worder (Behavioral)
结局指标
主要结局
MDT change in recognition memory
时间窗: baseline promptly before, post-training promptly after regimen is completed, and follow up six months after post-training tests
Psychometric test for proportion correct in memory for studied images of common objects versus paired similar lures
TOUR change in cued recall memory
时间窗: baseline promptly before, post-training promptly after regimen is completed, and follow up six months after post-training tests
Psychometric test for proportion of details correctly recalled from recent autobiographical memory
次要结局
- Cognitive Assessment change in working memory(baseline promptly before, post-training promptly after regimen is completed, and follow up six months after post-training tests)