An interventional study of Jigsawdio Multisensory Puzzle Platform and Standard Jigsaw Puzzle Activity in Alzheimer Disease, Dementia and Mild Cognitive Impairment, sponsored by Callahan-Young LLC DBA Jigsawdio. Not yet recruiting at 2 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Callahan-Young LLC DBA Jigsawdio · Not applicable, Interventional, and Supportive care
This study will evaluate Jigsawdio, a personalized multisensory jigsaw puzzle platform, for adults aged 60 years and older with mild cognitive impairment or mild dementia. Approximately 80 participants will be randomly assigned to either the Jigsawdio group or a control group using standard dementia-friendly jigsaw puzzles. Both groups will complete two 30- to 40-minute puzzle sessions per week for six weeks, for a total of 12 sessions.
Jigsawdio combines transparent physical puzzle pieces with personalized images, stories, and audio presented through an iPad. The study will compare changes in depression, anxiety, quality of life, cognition, engagement, satisfaction, and program feasibility. Assessments will be completed at baseline, after the six-week program, and at a 12-week follow-up. Information may also be collected from participants' caregivers or informants.
Exclusion Criteria:
Participants will complete two 30 to 40 minute Jigsawdio sessions per week for six weeks, for a total of 12 sessions. Jigsawdio combines transparent physical puzzle pieces with personalized images, stories, and audio presented through an iPad.
Behavioral: Jigsawdio Multisensory Puzzle Platform
Participants will complete two approximately 30- to 40-minute standard jigsaw puzzle sessions per week for six weeks, for a total of 12 sessions. Commercially available dementia-friendly puzzles will be used as the comparison activity.
Behavioral: Standard Jigsaw Puzzle Activity
Jigsawdio is a personalized multisensory puzzle platform that combines transparent physical puzzle pieces with images, stories, and audio presented through an iPad. Participants will complete two approximately 30- to 40-minute Jigsawdio sessions per week for six weeks, for a total of 12 sessions.
Participants will complete two approximately 30- to 40-minute standard jigsaw puzzle sessions per week for six weeks, for a total of 12 sessions. Commercially available dementia-friendly puzzles will be used as the comparison activity.
Change in Quality of Life Measured by the Quality of Life in Alzheimer's Disease Scale
Quality of life will be measured using the Quality of Life in Alzheimer's Disease scale (QoL-AD). Total scores range from 13 to 52, with higher scores indicating better quality of life.
Time frame: Baseline, Week 6, and Week 12
Change in Depressive Symptoms Measured by the Geriatric Depression Scale-15
Depressive symptoms will be measured using the 15-item Geriatric Depression Scale (GDS-15). Total scores range from 0 to 15, with higher scores indicating greater depressive symptoms.
Time frame: Baseline, Week 6, and Week 12
Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder-7
Anxiety symptoms will be measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). Total scores range from 0 to 21, with higher scores indicating greater anxiety symptoms.
Time frame: Baseline, Week 6, and Week 12
Change in Global Cognition Measured by the Montreal Cognitive Assessment
Global cognition will be measured using the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores indicating better cognitive performance.
Time frame: Baseline, Week 6, and Week 12
Change in PROMIS® Cognitive Function v2.0. Short Form 6a T-score
Perceived cognitive function will be measured using the six-item Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function v2.0 Short Form 6a. Raw scores are converted to standardized T-scores ranging from 23.13 to 63.17, with higher scores indicating better perceived cognitive function.
Time frame: Baseline, Week 6, and Week 12
Change in Caregiver-Reported Quality of Life
Caregivers or informants will complete the proxy version of the Quality of Life in Alzheimer's Disease scale. Scores range from 13 to 52, with higher scores indicating better perceived quality of life.
Time frame: Baseline, Week 6, and Week 12
Participant Engagement During Puzzle Sessions
Engagement will be evaluated during puzzle sessions using the Engagement of a Person with Dementia Scale (EPWDS). Each of the 10 items is rated from 1 to 5. Items 2, 4, 6, 8, and 10 are reverse scored. Total scores range from 10 to 50, with higher scores indicating greater positive engagement.
Time frame: During each of the 12 puzzle sessions over Weeks 1-6
Session Completion and Program Adherence
Adherence will be measured as the number and percentage of the 12 scheduled puzzle sessions completed by each participant.
Time frame: Through Week 6
Time on Task
The amount of time each participant spends engaged in each puzzle session will be recorded in minutes.
Time frame: During each of the 12 puzzle sessions over Weeks 1-6.
Participant and Caregiver Satisfaction and Acceptability
Participant and caregiver satisfaction, perceived benefits, and challenges associated with the program will be assessed through feedback interviews.
Time frame: Week 6
Recruitment Rate
Recruitment feasibility will be measured as the number and percentage of screened individuals who enroll in the study.
Time frame: At completion of enrollment, up to 7 months
Retention Rate
Retention will be measured as the number and percentage of enrolled participants who complete the Week 12 follow-up assessment.
Time frame: Through Week 12
Plan to share: Yes — Deidentified individual participant data underlying the study results will be shared through the Texas Data Repository. Shared data may include sociodemographic information, survey outcome data, and coded qualitative interview data. Direct identifiers and identifiable raw interview data will not be shared. Supporting materials may include metadata, codebooks, permitted data collection instruments, the study protocol, and analytic code. Access and reuse will be consistent with participant consent, applicable IRB requirements, and institutional data-sharing policies.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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