Working Memory Training in Patients with Mild Cognitive Impairment

Official title

CogMed Intervention Targeting Working Memory in Patients with Mild Cognitive Impairment

Overview

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.

Interventions

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

Primary outcome measures

• 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.]
• 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.]
• 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.]

Secondary outcome measures (11)

• Change in Blood biomarker [Time frame: 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.]
• Brief Resilience Scale (BRS) Score [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 [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 [Time frame: 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.]
• WHO Quality of Life Questionnaire [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) [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) [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) [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) [Time frame: Will be assessed at baseline and again at a 3-month follow-up following the intervention period.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

United States · 1 center

• Barrow Neurological Institute, Division of Alzheimer's Disease — Phoenix

Publications

• Apiquian R, Diaz R, Victoria G, Ulloa RE. The Category Fluency Test components and their association with cognition and symptoms in adolescents with schizophrenia. Schizophr Res Cogn. 2023 Nov 10;35:100296. doi: 10.1016/j.scog.2023.100296. eCollection 2024 Mar. PMID 38025823
• Kortte KB, Horner MD, Windham WK. The trail making test, part B: cognitive flexibility or ability to maintain set? Appl Neuropsychol. 2002;9(2):106-9. doi: 10.1207/S15324826AN0902_5. PMID 12214820
• Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667. PMID 9626712
• Flak MM, Hol HR, Hernes SS, Chang L, Engvig A, Bjuland KJ, Pripp A, Madsen BO, Knapskog AB, Ulstein I, Lona T, Skranes J, Lohaugen GCC. Adaptive Computerized Working Memory Training in Patients With Mild Cognitive Impairment. A Randomized Double-Blind Active Controlled Trial. Front Psychol. 2019 Apr 12;10:807. doi: 10.3389/fpsyg.2019.00807. eCollection 2019. PMID 31031677
• Wilson, K. G., Sandoz, E. K., Kitchens, J., & Roberts, M. E. (2010). "The Valued Living Questionnaire: Defining and measuring valued action within a behavioral framework." The Psychological Record 60: 249-272
• Reynolds, C. R. (2002). Comprehensive trail-making test : examiner's manual. Austin, Tex., Pro-Ed
• Rey, A. (1964). L'examen clinique en psychologie. Paris, Presses Universitaires de France
• Francis, A. W., D. L. Dawson and N. Golijani-Moghaddam (2016). "The development and validation of the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT)." Journal of Contextual Behavioral Science 5(3): 134-145

Identifiers

NCT: NCT06734286 · 24-500-385-30-53

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗