Alzheimer DiseaseNCT04384978

Socially Assistive Robots for Interaction With Older Adults With Dementia

A study testing Play Serious Games with a Social Robot (Ryan) and Play Solitary Games Without a Social Robot in people with Alzheimer Disease, run by DreamFace Technologies, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 65 years and older
Conditions the study is for: Alzheimer Disease
What is being tested?: Play Serious Games with a Social Robot (Ryan) and Play Solitary Games Without a Social Robot
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: 12 Jan 2020to 15 Apr 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Age ≥ 65 years
Early Alzheimer's disease and related dementia diagnosed by a qualified provider
Saint Louis University Mental Status (SLUMS) score between 10 and 25
Resident of assisted living facility for at least one month prior and for the duration of the study
Deemed conditioned enough to participate in physical activities after a wellness check
Verbal skill to interact
Participant or Legal decision

Who cannot join

Aggressive behavior
Diagnosed with severe dementia or memory loss
Acute physical illness that impairs ability to participate
Patients with serious comorbidity, tumors and other diseases casually related to cognitive impairment
History of alcohol or drug abuse, head trauma, psychoactive substance use and other causes of memory impairment
Significant sensory impairment

Trial locations and contacts

1 site in 1 country.

United States1 site

Eaton Senior Communities
Lakewood, Colorado, 80226

Other trials in United States

About this study

Official title: Development of Serious Games and Physical Activities Instructed by a Social Robot for Improving the Well-being of Elderly Individuals With Alzheimer's Disease and Dementia

A 12-month pilot study will be comprised of two groups of people diagnosed with mild Alzheimer's disease and related dementia for a total of 80 senior subjects. Subjects will be randomly assigned to two groups: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day. Group 2 (Active Control Group) will play solitary games and activities but will have to interaction with Ryan. The team will measure the changes and improvement in the social/emotional well-being of these two groups and eventual changes in the cognitive/memory functions of elderly people living in the similar environment.

Conditions: Alzheimer Disease
Being tested: Play Serious Games with a Social Robot (Ryan), Play Solitary Games Without a Social Robot
Medical subject headings: Alzheimer Disease

What participants receive

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

Play Serious Games with a Social Robot (Ryan)Behavioural
Active Group: Game play and physical activities with Ryan, a socially assistive robot developed at DreamFace Technologies,LLC.
Play Solitary Games Without a Social RobotBehavioural
Control Group: Group 2 will play solitary games (e.g., word puzzles) and activities but will have no interaction with Ryan.

Study groups in NCT04384978
Study group	Role	What they receive
Control Group	Active comparator	Control Group: Group 2 users will play solitary games (word puzzles) and activities but will have no interaction with Ryan. Receives: Behavioral: Play Solitary Games Without a Social Robot
Active Group	Experimental	Active Group: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day. Receives: Behavioral: Play Serious Games with a Social Robot (Ryan)

What is being measured

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

Change in Cognitive/Memory Ability
Participants will complete the Saint Louis University Mental Status (SLUMS) test, a screening method for Alzheimer's and other dementia. Scores range from 0 to 30. Scores of 27 to 30 are considered normal in a person with a high school education. Scores between 21 and 26 suggest a mild neurocognitive disorder. Scores between 0 and 20 indicate dementia.
Measured: assessed at baseline (week 1), week 4, and 8. Week 8 reported.

Timeline

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

12 Jan 202015 Apr 2022

First posted12 May 2020
Study start12 Jan 2020
Primary completion6 Mar 2022
Study completion15 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Model description: A 12-month pilot study will be comprised of two groups of people diagnosed with mild Alzheimer's disease and related dementia for a total of 80 senior subjects. Subjects will be randomly assigned to two groups: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day. Group 2 (Active Control Group) will play solitary games and activities but will have to interaction with Ryan. The team will measure the changes and improvement in the social/emotional well-being of these two groups and eventual changes in the cognitive/memory functions of elderly people living in the similar environment.
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04384978
Sponsor's protocol ID: 2020-001
Other IDs: R44AG066439-01
Status last verified: Jun 2024
First submitted: 5 May 2020
Last updated: 23 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development of Serious Games and Physical Activities Instructed by a Social Robot for Improving the Well-being of Elderly Individuals With Alzheimer's Disease and Dementia
ClinicalTrials.gov ID: NCT04384978
Acronym / sponsor ID: 2020-001
Conditions: Alzheimer Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: DreamFace Technologies, LLCIndustry (pharma, biotech, devices)
Collaborators: National Institute on Aging (NIA)
Study start: 12 Jan 2020 (actual)
Primary completion: 6 Mar 2022 (actual)
Study completion: 15 Apr 2022 (actual)
First posted: 12 May 2020 (actual)
Results: Posted 23 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: A 12-month pilot study will be comprised of two groups of people diagnosed with mild Alzheimer's disease and related dementia for a total of 80 senior subjects. Subjects will be randomly assigned to two groups: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day. Group 2 (Active Control Group) will play solitary games and activities but will have to interaction with Ryan. The team will measure the changes and improvement in the social/emotional well-being of these two groups and eventual changes in the cognitive/memory functions of elderly people living in the similar environment.

Arm	Type	Receives
Control Group	Active comparator	Behavioral: Play Solitary Games Without a Social RobotControl Group: Group 2 users will play solitary games (word puzzles) and activities but will have no interaction with Ryan.
Active Group	Experimental	Behavioral: Play Serious Games with a Social Robot (Ryan)Active Group: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (7 listed)

Age ≥ 65 years
Early Alzheimer's disease and related dementia diagnosed by a qualified provider
Saint Louis University Mental Status (SLUMS) score between 10 and 25
Resident of assisted living facility for at least one month prior and for the duration of the study
Deemed conditioned enough to participate in physical activities after a wellness check

Key exclusion criteria (6 listed)

Aggressive behavior
Diagnosed with severe dementia or memory loss
Acute physical illness that impairs ability to participate
Patients with serious comorbidity, tumors and other diseases casually related to cognitive impairment
History of alcohol or drug abuse, head trauma, psychoactive substance use and other causes of memory impairment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Play Serious Games with a Social Robot (Ryan)Active Group: Game play and physical activities with Ryan, a socially assistive robot developed at DreamFace Technologies,LLC.	Behavioural	Active Group
Play Solitary Games Without a Social RobotControl Group: Group 2 will play solitary games (e.g., word puzzles) and activities but will have no interaction with Ryan.	Behavioural	Control Group

Primary outcome

Change in Cognitive/Memory Ability
Time frame: assessed at baseline (week 1), week 4, and 8. Week 8 reported.
Participants will complete the Saint Louis University Mental Status (SLUMS) test, a screening method for Alzheimer's and other dementia. Scores range from 0 to 30. Scores of 27 to 30 are considered normal in a person with a high school education. Scores between 21 and 26 suggest a mild neurocognitive disorder. Scores between 0 and 20 indicate dementia.

Results and safety

Results posted to the registry on 23 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group	4	0
Active Group	18	18

Primary outcome: Change in Cognitive/Memory Ability

Time frame: assessed at baseline (week 1), week 4, and 8. Week 8 reported.. Mean (Standard Deviation). Unit: score on a scale

Measure	Active Group n = 18	Control Group n = 0
Value	23.75 (3.45)	–

Population analysed: The participants did not complete the study.

Adverse events

Time frame: The adverse events were monitored and assessed at the participant level (up to 10 weeks) throughout the study. As a result, no adverse events were reported during the study period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Active Group	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Limitations and caveats (from the sponsor): The study was conducted right after COVID-19 restrictions were lifted. The main limitation was that some potential subjects had medical constraints or concerns and did not want to participate. Additionally, poor internet connections in some senior care facilities limited the ability to converse with the robot.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 6 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: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 23 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cognitive/Memory Ability (time frame: assessed at baseline (week 1), week 4, and 8. Week 8 reported.). 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 NCT04384978.

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 23 Jul 2024.