Ryan Companion Robot for Assisting Elderly People With Alzheimer's Disease

February 27, 2024 updated by: DreamFace Technologies, LLC

Development of Ryan Companion Robot for Assisting Elderly People With Alzheimer's Disease

The objective of this project is to conduct research and a pilot study to demonstrate the potential clinical impact and technical feasibility of a socially-assistive robot, called Ryan Companionbot (hereafter Ryan), for life improvement and intervention of persons with early stage Alzheimer's disease (AD) and AD related dementia (ADRD). Earlier phases of this project demonstrated the feasibility and scalability of using emotion recognition technology based on cutting-edge natural language processing and artificial intelligence technologies to improve mood and lessen depression symptoms of persons with early stage AD/ADRD. In this phase, the investigators will utilize an aesthetically pleasing updated Ryan (V2.0) with emotion recognition and natural language processing for enhanced conversations to address the needs of the individuals with AD/ADRD and their healthcare providers as well as to test the effectiveness of Ryan by comparing participants pre- and post-treatment by analyzing several blood biomarkers related to AD/ADRD and depression. The investigators will recruit thirty participants from local senior living facilities based on their cognitive performance as assessed by the Saint Louis University Mental Status (SLUMS) score. SLUMS is commonly used as a simple screening/assessment test in senior living facilities. As part of the recruitment, the investigators will show prospective participants a video recording of a previous senior volunteer interacting with Ryan to give new recruits an idea of the socially assistive robot technology.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Lakewood, Colorado, United States, 80226
        • Eaton Senior Communities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • HAVING EARLY STAGE AD/ADRD AS ASSESSED BY THE SLUMS SCORE (BETWEEN 15-26),
  • VERBAL SKILL TO INTERACT,
  • BEING AVAILABLE FOR A PERIOD OF 8-10 WEEKS TO INTERACT WITH RYAN,
  • HEALTHY INDIVIDUALS WEIGHING AT LEAST 110 POUNDS (FOR SAFE COLLECTION OF BLOOD SAMPLES).

Exclusion Criteria:

  • AGGRESSIVE BEHAVIOR
  • DIAGNOSTICS OF SEVERE DEMENTIA OR MEMORY LOSS
  • ACUTE PHYSICAL ILLNESS THAT IMPAIRS ABILITY TO PARTICIPATE
  • DURING THE STUDY IF A PARTICIPANT'S MID-STUDY SLUMS SCORE IS LESS THAN 15 (INDICATING MORE SEVERE DEMENTIA) AND/OR THE PHQ-9 IS EQUAL TO OR GREATER THAN 20, THE CUTOFF FOR SEVERE DEPRESSION, THE RESEARCHERS WILL REMOVE THE PARTICIPANT FROM THE STUDY
  • IF A PERSON IS UNCOMFORTABLE WITH BLOOD DRAW, HE/SHE IS EXCLUDED FROM THE STUDY.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot Intervetnion
Participants in this Arm will interact with Ryan Companionbot.
Behavioral: Social Robot
Participants will interact with a social robot companionbot for a period of 8-10 weeks. The robot will stay in participants' apartments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Robot Usage Time
Time Frame: 8-10 weeks
How much time the user spends with the robot
8-10 weeks
Conversation Time
Time Frame: 8-10 weeks
How much time the user spends in conversation with the robot
8-10 weeks
Facial Expression
Time Frame: 8-10 weeks
Facial expressions throughout conversation with robot
8-10 weeks
Sentiment Analysis
Time Frame: 8-10 weeks
Speech is analyzed and is either classified as positive, neutral, or negative.
8-10 weeks
Amyloid-Beta - Alzheimer's disease
Time Frame: 8-10 weeks" Blood will be collected once before the robot is dropped off, once during the midpoint of the study, and once at the end of the study.
Levels of Amyloid-beta will be analyzed from blood collected at time of study. Amyloid-beta peptide is believed to drive Alzheimer's disease pathogenesis and is the main component of amyloid plaques.
8-10 weeks" Blood will be collected once before the robot is dropped off, once during the midpoint of the study, and once at the end of the study.
Phospho-Tau - Alzheimer's disease
Time Frame: 8-10 weeks" Blood will be collected once before the robot is dropped off, once during the midpoint of the study, and once at the end of the study.
Levels of Phospho-tau will be analyzed from blood collected at time of study. In Alzheimer's disease, tau instead of stabilizing microtubules detach from them and form tangles in the neurons.
8-10 weeks" Blood will be collected once before the robot is dropped off, once during the midpoint of the study, and once at the end of the study.
brain derived neurotrophic factor (BDNF) - depression
Time Frame: 8-10 weeks" Blood will be collected once before the robot is dropped off, once during the midpoint of the study, and once at the end of the study.
Levels of BDNF will be analyzed from blood collected at time of study. BDNF is believed to be decreased in patients experiencing depression.
8-10 weeks" Blood will be collected once before the robot is dropped off, once during the midpoint of the study, and once at the end of the study.
serotonin (5-HT) - this is for depression
Time Frame: 8-10 weeks" Blood will be collected once before the robot is dropped off, once during the midpoint of the study, and once at the end of the study.
Levels of Serotonin will be analyzed from blood collected at time of study. Serotonin is a neurotransmitter that has been linked to depression when depleted.
8-10 weeks" Blood will be collected once before the robot is dropped off, once during the midpoint of the study, and once at the end of the study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SLUMS score
Time Frame: The Saint Louis University Mental Status exam will be administered three times during the 8-10 week period. It is a 11 set questionnaire that is scored between 1 and 30 points. A higher score is a better outcome.
The SLUMS test is a screening tool for dementia and mild cognitive impairment.
The Saint Louis University Mental Status exam will be administered three times during the 8-10 week period. It is a 11 set questionnaire that is scored between 1 and 30 points. A higher score is a better outcome.
PHQ-9
Time Frame: The Patient Health Questionnaire-9 will be administered three times during the 8-10 week period. The score is between 0 and 27. Each questions is scored between "0" (not at all) to "3" (nearly every day). A higher score is a worse outcome.
The Patient Health Questionnaire-9 is a major depressive disorder screening module.
The Patient Health Questionnaire-9 will be administered three times during the 8-10 week period. The score is between 0 and 27. Each questions is scored between "0" (not at all) to "3" (nearly every day). A higher score is a worse outcome.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DreamFace Technologies, LLC

Investigators

  • Study Director: Stephanie Melgar, BS, University of Denver/ DFT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2021

Primary Completion (Actual)

May 30, 2022

Study Completion (Actual)

May 30, 2022

Study Registration Dates

First Submitted

September 4, 2021

First Submitted That Met QC Criteria

September 12, 2021

First Posted (Actual)

September 22, 2021

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We will share the final results and the data with other researchers after the data collection is over.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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