Working Memory Training in Patients with Mild Cognitive Impairment

NCT06734286 | Recruiting

• 1 other identifier: 24-500-385-30-53
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Mild Cognitive Impairment (MCI)

Keywords

CogMed; Mild cognitive Impairment; CogMed intervention targeting working memory; CogMed Intervention Vs Treatment as Usual; working memory training; Alzheimer's Disease

Outcome Measures

Primary Outcomes (3)

• Working 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.

  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.

  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.

  Will be assessed at baseline and again at a 3-month follow-up following the intervention period.

Secondary Outcomes (11)

• 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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

CogMed OTHER

CogMed which is a computerized working memory training program developed by Karolinska University.

Also known as: Computer based training program., CogMed Intervention.

Intervention Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead
• Barrow Neurological Foundation: collaborator
• Barrow Neurological Institute: collaborator

Study Sites (1)

Barrow Neurological Institute, Division of Alzheimer's Disease

Phoenix, Arizona, 85013, United States

RECRUITING

Related Publications (26)

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Related Links

• World Health Organization (2017). "Global action plan on the public health response to dementia 2017-2025."

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yonas E Geda, M.D, MSc

  Barrow Neurological Institute, Alzheimer's Disease and Cognitive Disorders Division

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yonas E Geda, M.D, MSc

CONTACT

833-233-3073; yonas.geda@commonspirit.org

Geetika Chahal, MBBS

CONTACT

602-406-7240; geetika.chahal@commonspirit.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, M.D.

Model Details: In this study, participant randomization into intervention and control groups will be performed using computer-generated random numbers. 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. For ethical reason, at the end of trial at 3 months, the control group will also be offered the CogMed intervention.

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 16, 2024
• Study Start: September 16, 2024
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)