Clinical trial NCT06734286: Working Memory Training in Patients with Mild Cognitive Impairment
Official title: CogMed Intervention Targeting Working Memory in Patients with Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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&#39;s Disease
Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sponsor class: OTHER
Collaborators: name: Barrow Neurological Foundation
name: Barrow Neurological Institute
First posted: 2024-12-16
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Working Memory as measured by the WAIS-IV Digit Span Forward/Backward
timeFrame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
measure: Working Memory as measured by the TMT-B
timeFrame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
measure: Working Memory as measured by Category Fluency Test
timeFrame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
Secondary outcomes:
measure: Change in Blood biomarker
timeFrame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
measure: Perceived Stress Scale (PSS) Score
timeFrame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
measure: Brief Resilience Scale (BRS) Score
timeFrame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
measure: Pittsburgh Sleep Quality Index (PSQI) Score
timeFrame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
measure: Physical Activity and Sedentary Behavior Questionnaire Score
timeFrame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
measure: Mediterranean Diet Scale(MedDiet)
timeFrame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
measure: WHO Quality of Life Questionnaire
timeFrame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
measure: Memory as measured by the Comprehensive Trail Making Test (CTMT)
timeFrame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
measure: Cognitive Impairment as measured by the Mini Mental State Examination (MMSE)
timeFrame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
measure: Verbal Memory as Measured by the Auditory Verbal Learning Test (AVLT)
timeFrame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
measure: Comprehensive Assessment of Acceptance and Commitment Therapy Process (CompACT)
timeFrame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute, Division of Alzheimer's Disease
state: Arizona
Study officials:
affiliation: Barrow Neurological Institute, Alzheimer's Disease and Cognitive Disorders Division
name: Yonas E Geda, M.D, MSc
role: PRINCIPAL_INVESTIGATOR
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