Working Memory Training in Patients with Mild Cognitive Impairment

Not Applicable

Recruiting

• Conditions: Mild Cognitive Impairment (MCI)

• Registration Number: NCT06734286
• Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix

Brief Summary

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).

Detailed Description

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 Timeline

• Study Start: 2024-09-16
• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-06-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Male or female outpatients ages ≥ 50 years;
2. Meet Mayo Clinic Criteria for MCI. (Patients with mild cognitive impairment)
3. Access to the internet through computer
4. 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.
5. Vision and hearing must be sufficient to comply with study procedures.

Exclusion Criteria

1. Mini Mental State Exam (MMSE) score less than 19 or patients diagnosed with moderate or severe dementia by a clinician.
2. In the opinion of the investigator, participation would not be in the best interest of the subject.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Working Memory as measured by the WAIS-IV Digit Span Forward/Backward	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in Blood biomarker	Will be assessed at baseline and again at a 3-month follow-up following the intervention period.	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.
Perceived Stress Scale (PSS) Score	Will be assessed at baseline and again at a 3-month follow-up following the intervention period.	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).
Brief Resilience Scale (BRS) Score	Will be assessed at baseline and again at a 3-month follow-up following the intervention period.	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).
Pittsburgh Sleep Quality Index (PSQI) Score	Will be assessed at baseline and again at a 3-month follow-up following the intervention period.	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).
Physical Activity and Sedentary Behavior Questionnaire Score	Will be assessed at baseline and again at a 3-month follow-up following the intervention period.	The Physical Activity and Sedentary Behavior Questionnaire will assess active time and time spent on exercise (PASB-Q; English Version) (Sattler et al., 2020).
WHO Quality of Life Questionnaire	Will be assessed at baseline and again at a 3-month follow-up following the intervention period.	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).
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.	The Comprehensive Trail Making Test (CTMT) is a measure of organized visual search, attention, set shifting and divided attention (Reynolds 2002).
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.	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)
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.	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).
Mediterranean Diet Scale(MedDiet)	Will be assessed at baseline and again at a 3-month follow-up following the intervention period.	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.
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.	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).

Trial Locations

Locations (1)

Barrow Neurological Institute, Division of Alzheimer's Disease; 🇺🇸 Phoenix, Arizona, United States