Jigsawdio Multisensory Platform for People With Mild Cognitive Impairment, Alzheimer's Disease, or Related Dementias
Evaluating the Health Benefits of Jigsawdio: A Novel Multisensory Jigsaw Puzzle-Based Platform for Alzheimer's Disease and Related Dementias
1 other identifier
interventional
80
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable alzheimer-disease
Started Oct 2026
Shorter than P25 for not_applicable alzheimer-disease
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2026
CompletedFirst Posted
Study publicly available on registry
September 24, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
September 25, 2026
September 1, 2026
7 months
August 13, 2026
September 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Baseline, Week 6, and Week 12
Secondary Outcomes (9)
Change in Global Cognition Measured by the Montreal Cognitive Assessment
Baseline, Week 6, and Week 12
Change in PROMIS® Cognitive Function v2.0. Short Form 6a T-score
Baseline, Week 6, and Week 12
Change in Caregiver-Reported Quality of Life
Baseline, Week 6, and Week 12
Participant Engagement During Puzzle Sessions
During each of the 12 puzzle sessions over Weeks 1-6
Session Completion and Program Adherence
Through Week 6
- +4 more secondary outcomes
Study Arms (2)
Jigsawdio Multisensory Puzzle Program
EXPERIMENTALParticipants 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.
Standard Jigsaw Puzzle Program
ACTIVE COMPARATORParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age: 60 years or older.
- Able to communicate fluently in English.
- Mild cognitive impairment or mild dementia based on an existing diagnosis or study screening procedures.
- Has an informant and a puzzle creator who know the participant and are willing to participate in the study; the same person may serve in both roles.
You may not qualify if:
- Severe uncorrected visual or hearing impairment that would prevent puzzle use.
- Severe motor impairment that would prevent puzzle use.
- Concurrent participation in a similar program or Alzheimer's disease intervention study.
- Current hospice care or terminal illness.
- Plans to relocate within three months after the baseline assessment.
- History of a serious mental illness, such as bipolar disorder or schizophrenia, that would interfere with study participation.
- Unable to provide informed consent and no legally authorized representative is available
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Callahan-Young LLC DBA Jigsawdiolead
- National Institute on Aging (NIA)collaborator
- Texas A&M Universitycollaborator
- Duke Universitycollaborator
Study Sites (2)
Duke University
Durham, North Carolina, 27710, United States
Texas A&M University
College Station, Texas, 77843, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Junhyoung Kim, PhD
Texas A&M University
- PRINCIPAL INVESTIGATOR
Maria Marquine, PhD
Duke University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2026
First Posted
September 24, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
September 25, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Deidentified individual participant data will be made available following publication of the primary study results and will be preserved for long-term access in accordance with repository policies.
- Access Criteria
- Deidentified individual participant data will be available through the Texas Data Repository to qualified researchers for purposes consistent with participant consent and applicable ethical requirements. Access will be subject to applicable institutional and IRB requirements and the repository's terms of access.
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.