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Completed

NCT Number: NCT05052866

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.

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Key information

Conditions

Alzheimer Disease, Early Onset Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eaton Senior Communities

Lakewood, Colorado, 80226, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

Primary outcomes

  1. Robot Usage Time

    Time frame: 8-10 weeks

    How much time the user spends with the robot

  2. Conversation Time

    Time frame: 8-10 weeks

    How much time the user spends in conversation with the robot

  3. Facial Expression

    Time frame: 8-10 weeks

    Facial expressions throughout conversation with robot

  4. Sentiment Analysis

    Time frame: 8-10 weeks

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

  5. 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.

  6. 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.

  7. 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. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

DreamFace Technologies, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 22, 2021
Registry last updated
Feb 28, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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