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Alzheimer DiseaseNCT07839286

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

A study testing Jigsawdio Multisensory Puzzle Platform and Standard Jigsaw Puzzle Activity in people with Alzheimer Disease and Dementia, run by Callahan-Young LLC DBA Jigsawdio at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Jigsawdio Multisensory Puzzle Platform and Standard Jigsaw Puzzle Activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesUnited States
Study dates
Oct 2026to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Amy M Young, BBA contact

9196965364

amy@jigsawdio.com

United States2 sites

  • Texas A&M University

    College Station, Texas, 77843

    Junhyoung Kim, PhD, 979-436-9372, kim9@tamu.edu

  • Duke University

    Durham, North Carolina, 27710

    Maria Marquine, PhD, (919) 681-2980, maria.marquine@duke.edu

Other trials in United States

About this study

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

Being tested
Jigsawdio Multisensory Puzzle Platform, Standard Jigsaw Puzzle Activity
Keywords
Jigsawdio, Multisensory Jigsaw Puzzle, Cognitive Engagement, Nonpharmacological Intervention, Older Adults, Quality of Life, Emotional Well-Being, Multisensory Engagement, Personalized Activities, dementia engagement
Medical subject headings
Alzheimer Disease, Dementia, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Jigsawdio Multisensory Puzzle PlatformBehavioural

    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 ActivityBehavioural

    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.

Study groups in NCT07839286
Study groupRoleWhat they receive
Jigsawdio Multisensory Puzzle ProgramExperimentalParticipants 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.
Receives: Behavioral: Jigsawdio Multisensory Puzzle Platform
Standard Jigsaw Puzzle ProgramActive 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.
Receives: Behavioral: Standard Jigsaw Puzzle Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 6, and Week 12

  2. 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.

    Measured: Baseline, Week 6, and Week 12

  3. 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.

    Measured: Baseline, Week 6, and Week 12

Secondary outcomes (9)

  1. 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.

    Measured: Baseline, Week 6, and Week 12

  2. 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.

    Measured: Baseline, Week 6, and Week 12

  3. 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.

    Measured: Baseline, Week 6, and Week 12

  4. 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.

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

  5. Session Completion and Program Adherence

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

    Measured: Through Week 6

  6. Time on Task

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

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

  7. Participant and Caregiver Satisfaction and Acceptability

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

    Measured: Week 6

  8. Recruitment Rate

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

    Measured: At completion of enrollment, up to 7 months

  9. Retention Rate

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

    Measured: Through Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07839286
Sponsor's protocol ID
2R44AG079736-02A1
Other IDs
2R44AG079736-02A1
Status last verified
Sep 2026
First submitted
13 Aug 2026
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Jigsawdio Multisensory Puzzle Platform and Standard Jigsaw Puzzle Activity in people with Alzheimer Disease and Dementia, run by Callahan-Young LLC DBA Jigsawdio at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amy M Young, BBA (9196965364, amy@jigsawdio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Quality of Life Measured by the Quality of Life in Alzheimer's Disease Scale (time frame: Baseline, Week 6, and Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07839286.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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Clinical Trial NCT07839286 | AzTrials