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

NCT06995638 | Recruiting DMC

• 2 other identifiers: Pro20250003304R00AG078561-03
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Aging; Alzheimer's Disease (AD)

Keywords

Aging; Cognition; Executive Functions; Randomized Controlled Trial; Cognitive Training; Neuropsychology

Outcome Measures

Primary Outcomes (2)

• Changes in the Breakfast Game scores

  Change in the total game performance based on specific scores (number of tables and cooking scores). Higher scores represent better game outcomes.

  Training session 1, week 1; training 10, approximately 4 weeks.

• Transfer to complex executive/attention control measure (Proximal outcome).

  Alphanumeric Task score.

  At baseline (week 1); post-intervention (weeks 10th to 12th); and at 3-month follow-up (week 24th)

Secondary Outcomes (4)

• Transfer to executive functions composite measure (Proximal outcome)

  At baseline (week 1); post-intervention (weeks 10th to 12th); and at 3-month follow-up (week 24th)

• Transfer to Everyday Cognition Scale (ECOG) (Distal outcome)

  At baseline (week 1); post-intervention (weeks 10th to 12th); and at 3-month follow-up (week 24th)

• Transfer to Mindful Attention Awareness Scale (MAAS) (Distal outcome)

  At baseline (week 1); post-intervention (weeks 10th to 12th); and at 3-month follow-up (week 24th)

• Transfer to Self Efficacy for Cognitive Everyday Tasks (Distal outcome)

  At baseline (week 1); post-intervention (weeks 10th to 12th); and at 3-month follow-up (week 24th)

Study Arms (3)

Strategy Training

EXPERIMENTAL

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.

Behavioral: Web-based Cognitive Training (with strategy)

Regular Training

ACTIVE COMPARATOR

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.

Behavioral: Web-based Cognitive Training (without strategy)

Passive Control

NO INTERVENTION

Interventions

Web-based Cognitive Training (with strategy) BEHAVIORAL

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

Strategy Training

Web-based Cognitive Training (without strategy) BEHAVIORAL

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

Regular Training

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

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

Newark, New Jersey, 07103, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 21120135 BACKGROUND

• 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.

  PMID: 21988726 BACKGROUND

• 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.

  PMID: 37542331 BACKGROUND

Related Links

• EngAGING Lab Website

Study Officials

• Sharon Sanz Simon Assistant Professor, Ph.D.

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thamiris Golçalves Clinical Research Coordinator, MS

CONTACT

973-972-2977; engaging.lab@rutgers.edu

Ana Staniscia Associate Research, MS

CONTACT

ana.staniscia@rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Principal Investigator)

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 29, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 6 months after article publication, and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact the PI lab email: engaging.lab@rutgers.edu.

Locations

US (1)