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Mild Cognitive Impairment (MCI)NCT06734286

Working Memory Training in Patients with Mild Cognitive Impairment

A study testing CogMed in people with Mild Cognitive Impairment (MCI), run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Mild Cognitive Impairment (MCI)
What is being tested?
CogMed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
16 Sep 2024to 30 Sep 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

United States1 site, 1 recruiting

  • Barrow Neurological Institute, Division of Alzheimer's Disease

    Phoenix, Arizona, 85013

    Yonas E Geda, M.D, MSc, 833-233-3073, yonas.geda@commonspirit.org

    Geetika Chahal, MBBS, 602-406-7240, Geetika.chahal@commonspirit.org

    Recruiting

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
CogMed
Keywords
CogMed, Mild cognitive Impairment, CogMed intervention targeting working memory, CogMed Intervention Vs Treatment as Usual, working memory training, Alzheimer's Disease
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CogMedOther

    Also called Computer based training program., CogMed Intervention.

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

Study groups in NCT06734286
Study groupRoleWhat they receive
Intervention GroupExperimentalThe 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).
Receives: Other: CogMed
Control GroupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (11)

  1. Change in Blood biomarker

    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.

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

  2. Perceived Stress Scale (PSS) Score

    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).

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

  3. Brief Resilience Scale (BRS) Score

    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).

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

  4. Pittsburgh Sleep Quality Index (PSQI) Score

    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).

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

  5. Physical Activity and Sedentary Behavior Questionnaire Score

    The Physical Activity and Sedentary Behavior Questionnaire will assess active time and time spent on exercise (PASB-Q; English Version) (Sattler et al., 2020).

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

  6. Mediterranean Diet Scale(MedDiet)

    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.

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

  7. WHO Quality of Life Questionnaire

    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).

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

  8. Memory as measured by the Comprehensive Trail Making Test (CTMT)

    The Comprehensive Trail Making Test (CTMT) is a measure of organized visual search, attention, set shifting and divided attention (Reynolds 2002).

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

  9. Cognitive Impairment as measured by the Mini Mental State Examination (MMSE)

    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)

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

  10. Verbal Memory as Measured by the Auditory Verbal Learning Test (AVLT)

    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).

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

  11. Comprehensive Assessment of Acceptance and Commitment Therapy Process (CompACT)

    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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2024
  2. Study start16 Sep 2024
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Investigator
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06734286
Sponsor's protocol ID
24-500-385-30-53
Status last verified
Nov 2024
First submitted
21 Nov 2024
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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

  • Wechsler, D. (1997). Wechsler Adult Intelligence Scale-III. New York, The Psychological Corporation.

  • Westwood AJ, Beiser A, Jain N, Himali JJ, DeCarli C, Auerbach SH, Pase MP, Seshadri S. Prolonged sleep duration as a marker of early neurodegeneration predicting incident dementia. Neurology. 2017 Mar 21;88(12):1172-1179. doi: 10.1212/WNL.0000000000003732. Epub 2017 Feb 22.

    PubMed 28228567

  • Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.

    PubMed 18696313

  • Simons DJ, Boot WR, Charness N, Gathercole SE, Chabris CF, Hambrick DZ, Stine-Morrow EA. Do "Brain-Training" Programs Work? Psychol Sci Public Interest. 2016 Oct;17(3):103-186. doi: 10.1177/1529100616661983.

    PubMed 27697851

  • Sattler MC, Jaunig J, Tosch C, Watson ED, Mokkink LB, Dietz P, van Poppel MNM. Current Evidence of Measurement Properties of Physical Activity Questionnaires for Older Adults: An Updated Systematic Review. Sports Med. 2020 Jul;50(7):1271-1315. doi: 10.1007/s40279-020-01268-x.

    PubMed 32125670

  • Norton MC, Clark CJ, Tschanz JT, Hartin P, Fauth EB, Gast JA, Dorsch TE, Wengreen H, Nugent C, Robinson WD, Lefevre M, McClean S, Cleland I, Schaefer SY, Aguilar S. The design and progress of a multidomain lifestyle intervention to improve brain health in middle-aged persons to reduce later Alzheimer's disease risk: The Gray Matters randomized trial. Alzheimers Dement (N Y). 2015 May 16;1(1):53-62. doi: 10.1016/j.trci.2015.05.001. eCollection 2015 Jun.

    PubMed 29854925

  • Marengoni A, Winblad B, Karp A, Fratiglioni L. Prevalence of chronic diseases and multimorbidity among the elderly population in Sweden. Am J Public Health. 2008 Jul;98(7):1198-200. doi: 10.2105/AJPH.2007.121137. Epub 2008 May 29.

    PubMed 18511722

Questions about this trial

What is this clinical trial studying?

A study testing CogMed in people with Mild Cognitive Impairment (MCI), run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yonas E Geda, M.D, MSc (833-233-3073, yonas.geda@commonspirit.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06734286, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.

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