Clinical trial NCT06995638: Improving Executive Control in Cognitively Healthy Older Adults: the MUltitasking STrategy (MUST) Study
Official title: Web-based Technology and Cognitive Training: Improving Executive Control in Cognitively Healthy Older Adults: the MUltitasking STrategy (MUST) Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Aging
Alzheimer&#39;s Disease (AD)
Keywords: Aging
Cognition
Executive Functions
Randomized Controlled Trial
Cognitive Training
Neuropsychology
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-05-29
Enrollment: 130
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in the Breakfast Game scores
timeFrame: Training session 1, week 1; training 10, approximately 4 weeks.
measure: Transfer to complex executive/attention control measure (proximal outcome).
timeFrame: At baseline (week 1); post-intervention (weeks 10th to 12th); and at 3-month follow-up (week 24th)
Secondary outcomes:
measure: Transfer to executive functions composite measure (distal outcome)
timeFrame: At baseline (week 1); post-intervention (weeks 10th to 12th); and at 3-month follow-up (week 24th)
measure: Transfer to Everyday Cognition Scale (ECOG) (Distal outcome)
timeFrame: At baseline (week 1); post-intervention (weeks 10th to 12th); and at 3-month follow-up (week 24th)
measure: Transfer to Mindful Attention Awareness Scale (MAAS) (Distal outcome)
timeFrame: At baseline (week 1); post-intervention (weeks 10th to 12th); and at 3-month follow-up (week 24th)
measure: Transfer to Self Efficacy for Cognitive Everyday Tasks (Distal outcome)
timeFrame: At baseline (week 1); post-intervention (weeks 10th to 12th); and at 3-month follow-up (week 24th)
Other outcomes:
Locations:
city: Newark
country: United States
facility: Rutgers New Jersey Medical School, Behavior Health Sciences Building, F-Level
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Sharon Sanz Simon Assistant Professor, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.