Working Memory Training in Patients with Mild Cognitive Impairment

December 12, 2024 updated by: Yonas Geda, St. Joseph's Hospital and Medical Center, Phoenix

CogMed Intervention Targeting Working Memory in Patients with Mild Cognitive Impairment

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
The Intervention Group (N = 5) Participants will be instructed to do CogMed intervention (computerized working memory activity carried out for 25 minutes daily for 5 days per week for a total of 10 weeks).
Other: CogMed
CogMed which is a computerized working memory training program developed by Karolinska University.
Other Names:
  • Computer based training program.
  • CogMed Intervention.
No Intervention: Control Group
The Control group(N = 5) follow there Treatment as usual(TAU). For ethical reasons, at the end of trial, the control group will also be offered the CogMed intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Working Memory as measured by the WAIS-IV Digit Span Forward/Backward
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
Will be assessed at baseline and again at a 3-month follow-up following the intervention period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood biomarker
Time Frame: 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.
Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
Perceived Stress Scale (PSS) Score
Time Frame: 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).
Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
Brief Resilience Scale (BRS) Score
Time Frame: 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).
Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
Pittsburgh Sleep Quality Index (PSQI) Score
Time Frame: 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).
Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
Physical Activity and Sedentary Behavior Questionnaire Score
Time Frame: 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).
Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
Mediterranean Diet Scale(MedDiet)
Time Frame: 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.
Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
WHO Quality of Life Questionnaire
Time Frame: 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).
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)
Time Frame: 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).
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)
Time Frame: 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)
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)
Time Frame: 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).
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)
Time Frame: 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).
Will be assessed at baseline and again at a 3-month follow-up following the intervention period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Collaborators

Barrow Neurological Institute
Barrow Neurological Foundation

Investigators

  • Principal Investigator: Yonas E Geda, M.D, MSc, Barrow Neurological Institute, Alzheimer's Disease and Cognitive Disorders Division

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

November 21, 2024

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-500-385-30-53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This project will be submitted for abstracts and/or publications following data analysis. If the findings are significant a follow up study will be proposed by applying to the NIH for additional grant funding.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mild Cognitive Impairment (MCI)

Clinical Trials on CogMed

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe