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NCT07839286
Jigsawdio Multisensory Platform for People With Mild Cognitive Impairment, Alzheimer's Disease, or Related Dementias
Conditions: Alzheimer Disease, Dementia, Mild Cognitive Impairment
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Callahan-Young LLC DBA Jigsawdio
Location: Duke University Durham North Carolina
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.
Eligibility Criteria
Inclusion Criteria:
1. Age: 60 years or older.
2. Able to communicate fluently in English.
3. Mild cognitive impairment or mild dementia based on an existing diagnosis or study screening procedures.
4. 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.
Exclusion Criteria:
1. Severe uncorrected visual or hearing impairment that would prevent puzzle use.
2. Severe motor impairment that would prevent puzzle use.
3. Concurrent participation in a similar program or Alzheimer's disease intervention study.
4. Current hospice care or terminal illness.
5. Plans to relocate within three months after the baseline assessment.
6. History of a serious mental illness, such as bipolar disorder or schizophrenia, that would interfere with study participation.
7. Unable to provide informed consent and no legally authorized representative is available
Source: ClinicalTrials.gov (NCT07839286). StuddyBuddy aggregates publicly available trial information.