CogMed Intervention Targeting Working Memory in Patients with Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Working Memory as measured by the WAIS-IV Digit Span Forward/Backward
研究概览
简要总结
The purpose of this study is to test whether a special memory training program, called CogMed, can help people with early memory problems. The Investigators want to see if this training improves memory and also helps reduce stress.
The Investigators also want to see if CogMed results in changes to a blood biomarker called p-Tau 217, which possibly indicate Alzheimer's disease (AD).
详细描述
The goal of this study is to conduct a pilot clinical trial aimed at comparing the effects of CogMed intervention plus Treatment As Usual (TAU) versus TAU alone in patients with Mild Cognitive Impairment (MCI). Based on our preliminary data from brain health program, the primary hypothesis is that the CogMed intervention may improve the CogMed measures and possibly working memory. This may improve sense of self-efficacy and lead to a decrease in perceived stress, thereby demonstrating possible transfer of cognitive benefits to biobehavioral construct of perceived stress. Additionally, the study aims to demonstrate the feasibility of collecting p-Tau 217, a blood based Alzheimer's Disease biomarker, from MCI patients. Though no significant changes in pTau 217 are expected due to the short duration of the study, the goal is to successfully recruit 10 MCI patients (5 in the intervention group and 5 in the control group) who are willing to undergo blood draws for p-Tau 217 level determination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients ages ≥ 50 years;
- •Meet Mayo Clinic Criteria for MCI. (Patients with mild cognitive impairment)
- •Access to the internet through computer
- •A proficiency in speaking and reading English or having a family member who is proficient in reading and speaking English and is willing to serve as a translator.
- •Vision and hearing must be sufficient to comply with study procedures.
排除标准
- •Mini Mental State Exam (MMSE) score less than 19 or patients diagnosed with moderate or severe dementia by a clinician.
- •In the opinion of the investigator, participation would not be in the best interest of the subject.
结局指标
主要结局
Working Memory as measured by the WAIS-IV Digit Span Forward/Backward
时间窗: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
The Digit Span Forward/Backward is a subset of the Wechsler Adult Intelligence Scale (WAIS) that captures attention efficiency and working memory.
Working Memory as measured by the TMT-B
时间窗: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
The Trail Making Test (TMT) is a well-established test sensitive to impairment in multiple cognitive domains.
Working Memory as measured by Category Fluency Test
时间窗: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
The Category Fluency Test (CFT) was created to assess semantic fluency. It consists of asking the individual to name as many animals as possible in 60 s. Performance on CFT can be evaluated through several components, such as the number of correct words, clusters, switching, related words, and intrusion and perseveration errors.
次要结局
- Change in Blood biomarker(Will be assessed at baseline and again at a 3-month follow-up following the intervention period.)
- Perceived Stress Scale (PSS) Score(Will be assessed at baseline and again at a 3-month follow-up following the intervention period.)
- Brief Resilience Scale (BRS) Score(Will be assessed at baseline and again at a 3-month follow-up following the intervention period.)
- Pittsburgh Sleep Quality Index (PSQI) Score(Will be assessed at baseline and again at a 3-month follow-up following the intervention period.)
- Physical Activity and Sedentary Behavior Questionnaire Score(Will be assessed at baseline and again at a 3-month follow-up following the intervention period.)
- WHO Quality of Life Questionnaire(Will be assessed at baseline and again at a 3-month follow-up following the intervention period.)
- Memory as measured by the Comprehensive Trail Making Test (CTMT)(Will be assessed at baseline and again at a 3-month follow-up following the intervention period.)
- Cognitive Impairment as measured by the Mini Mental State Examination (MMSE)(Will be assessed at baseline and again at a 3-month follow-up following the intervention period.)
- Verbal Memory as Measured by the Auditory Verbal Learning Test (AVLT)(Will be assessed at baseline and again at a 3-month follow-up following the intervention period.)
- Mediterranean Diet Scale(MedDiet)(Will be assessed at baseline and again at a 3-month follow-up following the intervention period.)
- Comprehensive Assessment of Acceptance and Commitment Therapy Process (CompACT)(Will be assessed at baseline and again at a 3-month follow-up following the intervention period.)
研究者
Yonas Geda
Principal Investigator, M.D.
St. Joseph's Hospital and Medical Center, Phoenix