A Phase 1/2 interventional study of Socially Assistive Robot Activity in Alzheimer Disease, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Vanderbilt University · Phase 1/2, Interventional, and Treatment
The objective of this study is to demonstrate the impact of a socially assistive robot system on reducing apathy among cognitively impaired older adults residing in long term care facilities. Earlier phases of this project demonstrated the feasibility and acceptability of the robotic system. First, investigators will improve the social robotic interaction architecture through additional software development, enhance its versatility, and make it easy for non-experts to run. Second, 188 participants will be randomized to either usual activity programs at the long term care facility, or the usual activity programs plus the robotic activities. Researchers will examine the effect on apathy and also plan on examining underlying individual and facility factors that influence the impact of the robotic activities.
Exclusion Criteria:
Participants will attend two sessions per week and interact with the robot. Four weeks with a humanoid robot and four weeks with a dog robot. Participants can continue to join other activities held within the facility.
Behavioral: Socially Assistive Robot Activity
Participants will attend at least two sessions per week at activities held within the facility. They will not be exposed to the robot activities.
Behavioral: Socially Assistive Robot Activity
Participants will attend two weekly sessions with robot activities. Each session will last 30 minutes. Participants will attend robot sessions for 8 weeks.
Change in Apathy
Apathy Evaluation Scale - Clinician (AES-C) will be used to assess changes in composite apathy score from baseline, Week 4, and Week 8. The AES-C is a validated 18-item instrument used to assess cognitive, behavioral, emotional and other symptoms of apathy. Clinicians rate each item based on verbal and nonverbal information provided by the participant. Item scores range from 1 (not at all characteristic) to 4 (a lot characteristic). Total scores range from 18 to 72 where higher derived scores indicate greater apathy.
Time frame: Baseline to Week 8
Change in Trail Making Test (TMT)
The TMT is a well established test of executive function and has two forms. TMT-A consists of a series of numbers in circles displayed randomly on a page; the person links the numbers in sequence. TMT-B consists of numbers (1 to 13) and letters (A to L) inside circles randomly placed on a page; the person alternates in connecting ascending numbers with ascending letters. TMT is scored by time in seconds to complete, up to 5 minutes. TMT-A normal time is 29 seconds and deficient score is \>78 seconds. TMT-B average score is 75 seconds and deficient score \> 273 seconds.
Time frame: Baseline to Week 8
Change in Animal Fluency Test
Verbal fluency tests require verbal ability and executive control processes; the Animal Naming test requires naming 15 animals in 1 minute; thus, less than 15 animals named in 1 minute is considered a deficient score.
Time frame: Baseline to Week 8
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Plan to share: Yes — All IPD that are de-identified and have been used in publications.
Supporting information: Study protocol, Sap, Analytic code
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Vanderbilt University