Alzheimer DiseaseNCT05178992
Use of Socially Assistive Robots for Long Term Care Older Adults With Cognitive Impairment and Apathy
A study testing Socially Assistive Robot Activity in people with Alzheimer Disease, run by Vanderbilt University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Socially Assistive Robot Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2023to 31 Jan 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residing >3 months in long term care facility
- Evidence of mild cognitive impairment (SAGE score 15-16), mild dementia (SAGE score <15, AD8<2, DSRD<19), or moderate dementia (SAGE <15, AD8>1, DSRD 19-36)
- Symptoms of apathy (Score 30+ on AES-C)
Who cannot join
- Severe cognitive impairment
- Physically unable to participate
- Unable to provide assent
- Uncorrected vision or hearing
- Never spoke English
- Unable to sit comfortably in chair
Show all 9Show fewer
- Acutely ill, terminally ill or unresponsive
- Unable to be moved to activity location
- Aggressive or combative
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University
Nashville, Tennessee, 37212-2010
About this study
Official title: Impact of a Novel Socially Assistive Robotic Architecture on Engaging Older Adults With Mild Cognitive Impairment, Alzheimer's Disease and Related Dementia in Long Term Care Settings
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.
- Conditions
- Alzheimer Disease
- Being tested
- Socially Assistive Robot Activity
- Keywords
- Apathy, Robotics, Virtual Reality
- Medical subject headings
- Alzheimer Disease, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socially Assistive Robot ActivityBehavioural
Participants will attend two weekly sessions with robot activities. Each session will last 30 minutes. Participants will attend robot sessions for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Socially Assistive Robot Activity | Experimental | 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. Receives: Behavioral: Socially Assistive Robot Activity |
| Usual Activity Program | Active comparator | Participants will attend at least two sessions per week at activities held within the facility. They will not be exposed to the robot activities. Receives: Behavioral: Socially Assistive Robot Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Apathy Score on the Clinician-rated Apathy Evaluation Scale (AES-C)
Apathy Evaluation Scale - Clinician (AES-C) was used to assess changes in composite apathy score from baseline to Week 4 and 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. Higher scores indicate greater apathy.
Measured: Baseline, Week 4, Week 8
Secondary outcomes (3)
Change in Trail Making Test (TMT) - A
The Trail Making Test (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. The score is based on length of time it takes the person to complete the sequence. TMT-A normal time is 29 seconds and a deficient score is >78 seconds. There is no minimum and maximum values. The lower the score, the better the cognitive function.
Measured: Baseline, 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.
Measured: Baseline, Week 8
Trail Making Test (TMT) - B
The Trail Making Test (TMT) is a well established test of executive function and has two forms. 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 a maximum of 5 minutes at which time the test is stopped. There is no minimum value. The average score for TMT-B is 75 seconds. A deficient score is one >273 seconds.
Measured: Baseline, Week8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start7 Feb 2023
- Primary completion31 Oct 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either Usual Activity Program or Usual Activity Program + Robot Activity within each long term care facility. At each site, the order of the robot type (humanoid or dog) will be randomized. Each participant will participate in two sessions/week for 8 weeks (4 weeks with humanoid robot, 4 weeks with dog robot).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Nilanjan Sarkar, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178992
- Sponsor's protocol ID
- 210386
- Other IDs
- R01AG062685
- Status last verified
- Oct 2026
- First submitted
- 15 Dec 2021
- Last updated
- 23 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that are de-identified and have been used in publications.
Publications
Ghosh R, Khan N, Migovich M, Tate JA, Maxwell CA, Newhouse PA, Scharre DW, Tan A, Mion LC, Sarkar N. Engaging Older Adults and Staff in the Co-Design and Evaluation of Socially Assistive Robot and Virtual Reality Activities for Long-Term Care: User-Centered Study. JMIR Aging. 2025 Dec 2;8:e75288. doi: 10.2196/75288.
PubMed 41330571Tate JA, Mion LC, Migovich M, Ghosh R, Khan N, Kilpatrick A, Scharre DW, Newhouse PA, Maxwell CA, Tan A, Sarkar N. A multi-site randomized clinical trial of socially assistive robots on engaging older adults with cognitive impairment residing in long-term care settings: A protocol paper. Contemp Clin Trials. 2025 Aug;155:107980. doi: 10.1016/j.cct.2025.107980. Epub 2025 Jun 6.
PubMed 40482961