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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
10
CogMed which is a computerized working memory training program developed by Karolinska University.
Barrow Neurological Institute, Division of Alzheimer's Disease
Phoenix, Arizona, United States
RECRUITINGWorking Memory as measured by the WAIS-IV Digit Span Forward/Backward
The Digit Span Forward/Backward is a subset of the Wechsler Adult Intelligence Scale (WAIS) that captures attention efficiency and working memory.
Time frame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
Working Memory as measured by the TMT-B
The Trail Making Test (TMT) is a well-established test sensitive to impairment in multiple cognitive domains.
Time frame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
Working Memory as measured by Category Fluency Test
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.
Time frame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
Change in Blood biomarker
We do not expect a significant change in p-Tau 217 during the short-proposed study duration, however, we projected that we will successfully recruit 10 MCI patients (Intervention group = N 5; and control group (N=5) that will be willing to undergo blood draw for determination of p-Tau 217 level.
Time frame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
Perceived Stress Scale (PSS) Score
The Perceived Stress Scale (PSS) is used for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. The scale also includes questions about current levels of experienced stress (Cohen et al, 1983).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
Brief Resilience Scale (BRS) Score
The Brief Resilience Scale (BRS) has 6 items and is a reliable means of assessing resilience as the ability to bounce back or recover from stress (Smith et al., 2008).
Time frame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
Pittsburgh Sleep Quality Index (PSQI) Score
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire designed to measure sleep quality and disturbance over past month (Buysse et al.,1989).
Time frame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
Physical Activity and Sedentary Behavior Questionnaire Score
The Physical Activity and Sedentary Behavior Questionnaire will assess active time and time spent on exercise (PASB-Q; English Version) (Sattler et al., 2020).
Time frame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
Mediterranean Diet Scale(MedDiet)
The MDScale includes nine components, including beneficial components (i.e., vegetables, legumes, fruits and nuts, cereal, and fish), detrimental components (i.e., meat, poultry, and high-fat dairy products), ethanol intake, and the ratio of monounsaturated to saturated fatty acids.
Time frame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
WHO Quality of Life Questionnaire
The WHO QOL has four domains (physical health, psychological, social relationships, and environment). The four domain scores denote an individual's perception of quality of life in each particular domain (WHOQOL Group, 1998).
Time frame: 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)
The Comprehensive Trail Making Test (CTMT) is a measure of organized visual search, attention, set shifting and divided attention (Reynolds 2002).
Time frame: 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)
The Mini Mental State Examination (MMSE) is used extensively in clinical and research settings to systematically measure and assess mental status. It is an 11- question measure that tests five areas of cognitive function: orientation, registration, attention, and calculation, recall, and language (Folstein et al., 1975)
Time frame: 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)
The Auditory Verbal Learning Test (AVLT) evaluates verbal memory by presenting a 15- word list five times followed by attempted recall. This is followed by a second 15-word recall interference list, followed by recall of the original list (Rey A. 1964).
Time frame: 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)
The Comprehensive Assessment of Acceptance and Commitment Therapy Process (CompACT) is a 23 item questionnaire that measures ACT processes, including psychological flexibility (Francis et al., 2016).
Time frame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.