Improving Executive Control in Cognitively Healthy Older Adults: the MUltitasking STrategy (MUST) Study

NCT ID: NCT06995638

Last Updated: 2025-12-15

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-10

Study Completion Date

2027-12-31

Brief Summary

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Developing efficient cognitive intervention for cognitively health older adults is a major public health goal, due to its potential for reducing age-related cognitive decline and Alzheimer's disease/dementia risk. Executive Control is a relevant cognitive target since it declines with aging and is critical for multi-tasking in daily life. The proposed research investigates whether playing a web-based cognitive complex game (the Breakfast Game) impacts cognitive performance in cognitively healthy older adults. To be enrolled in the study, participants will be asked to undergo a cognitive sassessment, health questionnires, and a blood exam. The intervention consist in one educational session on healthy aging, and 10 one-hour cognitive training sessions 2-3 times a week over one month. Participants will be asked to repeat the cognitive assessment within 1-2 weeks after the intervention, and after three months.

Detailed Description

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The proposed research investigates whether exposure to a web-based training protocol designed to enhance executive control / multi-tasking abilities will improve cognitive performance in cognitively healthy older adults. Cognitively normal adults aged 60-75 will be randomized into three groups: 1) Web-based game with training strategy (Experimental); 2) Web-based game without training strategy (Active Control); 3) No intervention group (Passive control). Participants in groups 1 and 2 will be instructed to play the complex, high-demand online game, the Breakfast Game, for 10 one-hour sessions over 4 weeks. At study entry all participants will be asked to complete a cognitive assessment, health questionnaires, a blood exam and and education session on healthy aging. After the intervention, participants will be asked to repeat the cogntive assessment within 1-2 weeks, and after 3 months.

Conditions

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Healthy Aging Alzheimer's Disease (AD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants will not be aware of the difference between the two active conditions. Assessor will not be aware in which group condition the participant was allocated.

Study Groups

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Strategy Training

Participants will undergo a web-based training protocol that involves playing an online game simulating a breakfast environment, where they will perform everyday activities such as "cooking" and "setting tables" in a multitasking fashion. Participants will learn to play the game using specific strategies to optimize their performance.

Group Type EXPERIMENTAL

Web-based Cognitive Training (with strategy)

Intervention Type BEHAVIORAL

Participants will learn to play a complex online game using specific guidance or strategy.

Regular Training

Participants will undergo a web-based training protocol that involves playing an online game simulating a breakfast environment, where they will perform everyday activities such as "cooking" and "setting tables" in a multitasking fashion. Participants will learn to play the game under regular game instructions.

Group Type ACTIVE_COMPARATOR

Web-based Cognitive Training (without strategy)

Intervention Type BEHAVIORAL

Participants will learn to play a complex online game without specific guidance or strategy.

Passive Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Web-based Cognitive Training (with strategy)

Participants will learn to play a complex online game using specific guidance or strategy.

Intervention Type BEHAVIORAL

Web-based Cognitive Training (without strategy)

Participants will learn to play a complex online game without specific guidance or strategy.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 60-75
* Adequate English proficiency
* Willingness to adhere to training protocol:

* Attend 2 in-person assessments
* Attend a blood test
* Attend online intervention sessions and online follow-up assessment

Exclusion Criteria

* Low test scores (below 26 on the Montreal Cognitive Assessment)
* Known history of cognitive impairment, dementia, stroke, seizure disorder, or other neuropsychiatric condition judged to impact cognitive performance.
* Taking medications known to influence cognitive performance.
* Sensory (e.g. visual, auditory) or physical (e.g. severe arthritic, orthopedic, neurologic) impairment incompatible with use of a standard computer workstation.
* Enrolled in a concurrent study that could affect the outcome of this study.
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Sharon Sanz Simon, Ph.D.

Assistant Professor (Principal Investigator)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sharon Sanz Simon Assistant Professor, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

Locations

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Rutgers New Jersey Medical School, Behavior Health Sciences Building, F-Level

Newark, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Thamiris Golçalves Clinical Research Coordinator, MS

Role: CONTACT

973-972-2977

Ana Staniscia Associate Research, MS

Role: CONTACT

Facility Contacts

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Thamiris Gonçalves Clinical Research Coordinator, MS

Role: primary

973-972-2977

Ana Staniscia, MA

Role: backup

References

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Blumen HM, Gopher D, Steinerman JR, Stern Y. Training cognitive control in older adults with the space fortress game: the role of training instructions and basic motor ability. Front Aging Neurosci. 2010 Nov 11;2:145. doi: 10.3389/fnagi.2010.00145. eCollection 2010.

Reference Type BACKGROUND
PMID: 21120135 (View on PubMed)

Stern Y, Blumen HM, Rich LW, Richards A, Herzberg G, Gopher D. Space Fortress game training and executive control in older adults: a pilot intervention. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2011 Nov;18(6):653-77. doi: 10.1080/13825585.2011.613450. Epub 2011 Oct 12.

Reference Type BACKGROUND
PMID: 21988726 (View on PubMed)

Sanz Simon S, Ben-Eliezer D, Pondikos M, Stern Y, Gopher D. Feasibility and acceptability of a new web-based cognitive training platform for cognitively healthy older adults: the breakfast task. Pilot Feasibility Stud. 2023 Aug 4;9(1):136. doi: 10.1186/s40814-023-01359-2.

Reference Type BACKGROUND
PMID: 37542331 (View on PubMed)

Related Links

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Other Identifiers

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4R00AG078561-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro2025000330

Identifier Type: -

Identifier Source: org_study_id

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