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

NCT05052866 | Completed DMC

• 1 other identifier: 2021-02
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease, Early Onset

Outcome Measures

Primary Outcomes (8)

• Robot Usage Time

  How much time the user spends with the robot

  8-10 weeks

• Conversation Time

  How much time the user spends in conversation with the robot

  8-10 weeks

• Facial Expression

  Facial expressions throughout conversation with robot

  8-10 weeks

• Sentiment Analysis

  Speech is analyzed and is either classified as positive, neutral, or negative.

  8-10 weeks

• Amyloid-Beta - Alzheimer's disease

  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

  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

  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

  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 Outcomes (2)

• SLUMS score

  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

  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.

Study Arms (1)

Robot Intervetnion

EXPERIMENTAL

Participants in this Arm will interact with Ryan Companionbot.

Behavioral: Social Robot

Interventions

Social Robot BEHAVIORAL

Participants will interact with a social robot companionbot for a period of 8-10 weeks. The robot will stay in participants' apartments.

Robot Intervetnion

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• DreamFace Technologies, LLC: lead

Study Sites (1)

Eaton Senior Communities

Lakewood, Colorado, 80226, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Robotics

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Automation; Technology; Technology, Industry, and Agriculture

Study Officials

• Stephanie Melgar, BS

  University of Denver/ DFT

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2021
• First Posted: September 22, 2021
• Study Start: April 21, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

US (1)