Clinical trial NCT05052866: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease, Early Onset
Lead sponsor: DreamFace Technologies, LLC
Sponsor class: INDUSTRY
First posted: 2021-09-22
Enrollment: 18
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Robot Usage Time
timeFrame: 8-10 weeks
measure: Conversation Time
timeFrame: 8-10 weeks
measure: Facial Expression
timeFrame: 8-10 weeks
measure: Sentiment Analysis
timeFrame: 8-10 weeks
measure: Amyloid-Beta - Alzheimer's disease
timeFrame: 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.
measure: Phospho-Tau - Alzheimer's disease
timeFrame: 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.
measure: brain derived neurotrophic factor (BDNF) - depression
timeFrame: 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.
measure: serotonin (5-HT) - this is for depression
timeFrame: 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:
measure: SLUMS score
timeFrame: 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.
measure: PHQ-9
timeFrame: 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.
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Eaton Senior Communities
state: Colorado
Study officials:
affiliation: University of Denver/ DFT
name: Stephanie Melgar, BS
role: STUDY_DIRECTOR
References: