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NCT Number: NCT07839286

Jigsawdio Multisensory Platform for People With Mild Cognitive Impairment, Alzheimer's Disease, or Related Dementias

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University, Durham, North Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Jigsawdio Multisensory Puzzle Platform

Behavioral

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.

Standard Jigsaw Puzzle Activity

Behavioral

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.

Primary outcomes

  1. Change in Quality of Life Measured by the Quality of Life in Alzheimer's Disease Scale

    Time frame: Baseline, Week 6, and Week 12

    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.

  2. Change in Depressive Symptoms Measured by the Geriatric Depression Scale-15

    Time frame: Baseline, Week 6, and Week 12

    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.

  3. Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder-7

    Time frame: Baseline, Week 6, and Week 12

    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.

Secondary outcomes

  1. Change in Global Cognition Measured by the Montreal Cognitive Assessment

    Time frame: Baseline, Week 6, and Week 12

    Global cognition will be measured using the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores indicating better cognitive performance.

  2. Change in PROMIS® Cognitive Function v2.0. Short Form 6a T-score

    Time frame: Baseline, Week 6, and Week 12

    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.

  3. Change in Caregiver-Reported Quality of Life

    Time frame: Baseline, Week 6, and Week 12

    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.

  4. Participant Engagement During Puzzle Sessions

    Time frame: During each of the 12 puzzle sessions over Weeks 1-6

    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.

  5. Session Completion and Program Adherence

    Time frame: Through Week 6

    Adherence will be measured as the number and percentage of the 12 scheduled puzzle sessions completed by each participant.

  6. Time on Task

    Time frame: During each of the 12 puzzle sessions over Weeks 1-6.

    The amount of time each participant spends engaged in each puzzle session will be recorded in minutes.

  7. Participant and Caregiver Satisfaction and Acceptability

    Time frame: Week 6

    Participant and caregiver satisfaction, perceived benefits, and challenges associated with the program will be assessed through feedback interviews.

  8. Recruitment Rate

    Time frame: At completion of enrollment, up to 7 months

    Recruitment feasibility will be measured as the number and percentage of screened individuals who enroll in the study.

  9. Retention Rate

    Time frame: Through Week 12

    Retention will be measured as the number and percentage of enrolled participants who complete the Week 12 follow-up assessment.

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Sponsors and collaborators

Lead sponsor

Callahan-Young LLC DBA Jigsawdio

Industry

Collaborators

  • Duke University
  • National Institute on Aging (NIA)
  • Texas A&M University

Registry information

Official study title

Evaluating the Health Benefits of Jigsawdio: A Novel Multisensory Jigsaw Puzzle-Based Platform for Alzheimer's Disease and Related Dementias

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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