Working Memory Training in Patients with Mild Cognitive Impairment

NCT ID: NCT06734286

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-16

Study Completion Date

2025-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment (MCI)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

CogMed

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CogMed

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Computer based training program. CogMed Intervention.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Barrow Neurological Foundation

OTHER

Sponsor Role collaborator

Barrow Neurological Institute

OTHER

Sponsor Role collaborator

St. Joseph's Hospital and Medical Center, Phoenix

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yonas Geda

Principal Investigator, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yonas E Geda, M.D, MSc

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Barrow Neurological Institute, Division of Alzheimer's Disease

Phoenix, Arizona, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yonas E Geda, M.D, MSc

Role: CONTACT

Phone: 833-233-3073

Email: [email protected]

Geetika Chahal, MBBS

Role: CONTACT

Phone: 602-406-7240

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yonas E Geda, M.D, MSc

Role: primary

Geetika Chahal, MBBS

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 38025823 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12214820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9626712 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31031677 (View on PubMed)

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

Reference Type BACKGROUND

Reynolds, C. R. (2002). Comprehensive trail-making test : examiner's manual. Austin, Tex., Pro-Ed

Reference Type BACKGROUND

Rey, A. (1964). L'examen clinique en psychologie. Paris, Presses Universitaires de France

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 28228567 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18696313 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27697851 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32125670 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29854925 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18511722 (View on PubMed)

Livingston G, Sommerlad A, Orgeta V, Costafreda SG, Huntley J, Ames D, Ballard C, Banerjee S, Burns A, Cohen-Mansfield J, Cooper C, Fox N, Gitlin LN, Howard R, Kales HC, Larson EB, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care. Lancet. 2017 Dec 16;390(10113):2673-2734. doi: 10.1016/S0140-6736(17)31363-6. Epub 2017 Jul 20. No abstract available.

Reference Type BACKGROUND
PMID: 28735855 (View on PubMed)

Krell-Roesch J, Vemuri P, Pink A, Roberts RO, Stokin GB, Mielke MM, Christianson TJ, Knopman DS, Petersen RC, Kremers WK, Geda YE. Association Between Mentally Stimulating Activities in Late Life and the Outcome of Incident Mild Cognitive Impairment, With an Analysis of the APOE epsilon4 Genotype. JAMA Neurol. 2017 Mar 1;74(3):332-338. doi: 10.1001/jamaneurol.2016.3822.

Reference Type BACKGROUND
PMID: 28135351 (View on PubMed)

Krell-Roesch J, Syrjanen JA, Vassilaki M, Barisch-Fritz B, Trautwein S, Boes K, Woll A, Kremers WK, Machulda MM, Mielke MM, Knopman DS, Petersen RC, Geda YE. Association of non-exercise physical activity in mid- and late-life with cognitive trajectories and the impact of APOE epsilon4 genotype status: the Mayo Clinic Study of Aging. Eur J Ageing. 2019 Apr 12;16(4):491-502. doi: 10.1007/s10433-019-00513-1. eCollection 2019 Dec.

Reference Type BACKGROUND
PMID: 31798373 (View on PubMed)

Krell-Roesch J, Pink A, Roberts RO, Stokin GB, Mielke MM, Spangehl KA, Bartley MM, Knopman DS, Christianson TJ, Petersen RC, Geda YE. Timing of Physical Activity, Apolipoprotein E epsilon4 Genotype, and Risk of Incident Mild Cognitive Impairment. J Am Geriatr Soc. 2016 Dec;64(12):2479-2486. doi: 10.1111/jgs.14402. Epub 2016 Nov 1.

Reference Type BACKGROUND
PMID: 27801933 (View on PubMed)

Krell-Roesch J, Feder NT, Roberts RO, Mielke MM, Christianson TJ, Knopman DS, Petersen RC, Geda YE. Leisure-Time Physical Activity and the Risk of Incident Dementia: The Mayo Clinic Study of Aging. J Alzheimers Dis. 2018;63(1):149-155. doi: 10.3233/JAD-171141.

Reference Type BACKGROUND
PMID: 29614667 (View on PubMed)

Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018.

Reference Type BACKGROUND
PMID: 29653606 (View on PubMed)

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

Reference Type BACKGROUND
PMID: 6668417 (View on PubMed)

Hachinski V, Einhaupl K, Ganten D, Alladi S, Brayne C, Stephan BCM, Sweeney MD, Zlokovic B, Iturria-Medina Y, Iadecola C, Nishimura N, Schaffer CB, Whitehead SN, Black SE, Ostergaard L, Wardlaw J, Greenberg S, Friberg L, Norrving B, Rowe B, Joanette Y, Hacke W, Kuller L, Dichgans M, Endres M, Khachaturian ZS. Preventing dementia by preventing stroke: The Berlin Manifesto. Alzheimers Dement. 2019 Jul;15(7):961-984. doi: 10.1016/j.jalz.2019.06.001.

Reference Type BACKGROUND
PMID: 31327392 (View on PubMed)

Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

Reference Type BACKGROUND
PMID: 1202204 (View on PubMed)

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

Reference Type BACKGROUND
PMID: 2748771 (View on PubMed)

Brookmeyer R, Gray S, Kawas C. Projections of Alzheimer's disease in the United States and the public health impact of delaying disease onset. Am J Public Health. 1998 Sep;88(9):1337-42. doi: 10.2105/ajph.88.9.1337.

Reference Type BACKGROUND
PMID: 9736873 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://www.who.int/publications/i/item/global-action-plan-on-the-public-health-response-to-dementia-2017---2025

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

24-500-385-30-53

Identifier Type: -

Identifier Source: org_study_id