Ryan Companion Robot for Assisting Elderly People With Alzheimer's Disease
Primary Purpose
Alzheimer Disease, Early Onset
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Robot
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer Disease, Early Onset
Eligibility Criteria
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.
Sites / Locations
- Eaton Senior CommunitiesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Robot Intervetnion
Arm Description
Participants in this Arm will interact with Ryan Companionbot.
Outcomes
Primary Outcome Measures
Robot Usage Time
How much time the user spends with the robot
Conversation Time
How much time the user spends in conversation with the robot
Facial Expression
Facial expressions throughout conversation with robot
Sentiment Analysis
Speech is analyzed and is either classified as positive, neutral, or negative.
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.
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.
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.
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.
Secondary Outcome Measures
SLUMS score
The SLUMS test is a screening tool for dementia and mild cognitive impairment.
PHQ-9
The Patient Health Questionnaire-9 is a major depressive disorder screening module.
Full Information
NCT ID
NCT05052866
First Posted
September 4, 2021
Last Updated
September 12, 2021
Sponsor
DreamFace Technologies, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05052866
Brief Title
Ryan Companion Robot for Assisting Elderly People With Alzheimer's Disease
Official Title
Development of Ryan Companion Robot for Assisting Elderly People With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DreamFace Technologies, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Early Onset
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robot Intervetnion
Arm Type
Experimental
Arm Description
Participants in this Arm will interact with Ryan Companionbot.
Intervention Type
Behavioral
Intervention Name(s)
Social Robot
Intervention Description
Participants will interact with a social robot companionbot for a period of 8-10 weeks. The robot will stay in participants' apartments.
Primary Outcome Measure Information:
Title
Robot Usage Time
Description
How much time the user spends with the robot
Time Frame
8-10 weeks
Title
Conversation Time
Description
How much time the user spends in conversation with the robot
Time Frame
8-10 weeks
Title
Facial Expression
Description
Facial expressions throughout conversation with robot
Time Frame
8-10 weeks
Title
Sentiment Analysis
Description
Speech is analyzed and is either classified as positive, neutral, or negative.
Time Frame
8-10 weeks
Title
Amyloid-Beta - Alzheimer's disease
Description
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.
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.
Title
Phospho-Tau - Alzheimer's disease
Description
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.
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.
Title
brain derived neurotrophic factor (BDNF) - depression
Description
Levels of BDNF will be analyzed from blood collected at time of study. BDNF is believed to be decreased in patients experiencing 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.
Title
serotonin (5-HT) - this is for depression
Description
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.
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.
Secondary Outcome Measure Information:
Title
SLUMS score
Description
The SLUMS test is a screening tool for dementia and mild cognitive impairment.
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.
Title
PHQ-9
Description
The Patient Health Questionnaire-9 is a major depressive disorder screening module.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad H Mahoor, PhD
Phone
7202015694
Email
mmahoor@dreamfacetech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eshrat S Emamian, DDS/PhD
Phone
7202015855
Email
emamianesh@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Melgar, BS
Organizational Affiliation
University of Denver/ DFT
Official's Role
Study Director
Facility Information:
Facility Name
Eaton Senior Communities
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Delgado, MS
Phone
303-937-3096
Email
ddelgado@eatonsenior.org
First Name & Middle Initial & Last Name & Degree
Sarah Schoeder, BS
Phone
303-937-3096
Email
sschoeder@eatonsenior.org
First Name & Middle Initial & Last Name & Degree
Mohammad Mahoor, PhD
First Name & Middle Initial & Last Name & Degree
Eshrat Emamian, DDS/PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
We will share the final results and the data with other researchers after the data collection is over.
Learn more about this trial
Ryan Companion Robot for Assisting Elderly People With Alzheimer's Disease
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