An 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 2026-10-23.
Sponsored by Vanderbilt University · Not applicable, Interventional, and Treatment
Among 1,937 studies in Alzheimer Disease with a site in United States — 343 open to participants now, 444 under way, 39 of them phase 3. Alzheimer Disease · United States.
Among the 1,937 studies in Alzheimer Disease with a site in United States, this one is the 552nd largest by enrollment of the 1,606 interventional ones, is one of 115 that started in 2023, is one of 607 with no phase, and was the 1,398th registered.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's enrollment of 142 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →343 of the 1,937 studies in Alzheimer Disease with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 641 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 54 (8%) stop at 75 or younger; 34 take children under 18; 283 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
The full table on the hub →1,937 studies; the count open now beside each. This study's row is marked.
First in 1981; this study’s year is marked. 115 started in 2023.
Median enrollment 73 across the 1,606 interventional studies, 160 across the 309 observational. Of the 1,376 that completed or were terminated, 590 (43%) have results posted.
730 of 1,937 have an industry lead sponsor. The 10 most frequent:
Vanderbilt University is the lead sponsor of 522 studies on the registry; 20 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.
Vanderbilt University has 2 studies filed under Alzheimer Disease — fewer than ten, so there is no comparison to draw.
165 of the studies in Alzheimer Disease with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06585787Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4) | 2026-11-24 |
| NCT06126224Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2) | 2026-12-09 |
| NCT03860857Phase 3University of California, IrvineBiomarker Exploration in Aging, Cognition and Neurodegeneration | 2026-12-22 |
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT05980949Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyOpen-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3) | 2027-09-07 |
Among the 1,937 studies in Alzheimer Disease with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 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.
Time frame: Baseline, Week 4, Week 8
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week8
Participants were recruited from 23 eligible long term care settings between February 2023 and September 2023. The first participant was enrolled on February x 2023 and the last participant was enrolled in September 2023.
| Milestone | Socially Assistive Robot Activity | Usual Activity Program |
|---|---|---|
| Started | 71 | 71 |
| Completed | 64 | 67 |
| Not completed | 7 | 4 |
| Withdrew: Withdrawal by subject | 4 | 0 |
| Withdrew: Worsening health | 2 | 4 |
| Withdrew: Lost to follow-up | 1 | 0 |
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.
| score on a scale | Socially Assistive Robot Activity | Usual Activity Program |
|---|---|---|
| Baseline Apathy Score on the AES-C | 42.5 ± 10.5 | 42.2 ± 10.1 |
| Week 4 Apathy Score on AES-C | 43.0 ± 11.2 | 43.1 ± 12.3 |
| Week 8 Apathy Score on the AES-C | 43.7 ± 13.8 | 42.5 ± 11.7 |
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.
| time in seconds | Socially Assistive Robot Activity | Usual Activity Program |
|---|---|---|
| Baseline TMT-A Scores | 132.5 ± 88.0 | 128.1 ± 84.9 |
| Week 8 TMT-A Scores | 119.6 ± 90.2 | 136.1 ± 95.4 |
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.
| number of animals | Socially Assistive Robot Activity | Usual Activity Program |
|---|---|---|
| Baseline Animal Fluency Score | 8.5 ± 4.7 | 8.9 ± 4.5 |
| Week 8 Animal Fluency Score | 8.7 ± 5.0 | 9.1 ± 4.5 |
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.
| score on a scale | Socially Assistive Robot Activity | Usual Activity Program |
|---|---|---|
| Baseline | 257.7 ± 68.8 | 249.8 ± 70.5 |
| Week 8 | 241.6 ± 77.0 | 248.1 ± 74.4 |
Collected over The participants were evaluated for adverse events for the period of study completion only, a total of 8 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Socially Assistive Robot Activity | 0/71 (0%) | 0/71 (0%) | 0/71 (0%) |
| Usual Activity Program | 2/71 (2.8%) | 0/71 (0%) | 0/71 (0%) |
| Age, Continuous(Years) | Socially Assistive Robot Activity | Usual Activity Program | Total |
|---|---|---|---|
| Mean | 84.7 ± 8.4 | 83.3 ± 9.1 | 84.0 ± 8.7 |
| Sex: Female, Male(Participants) | Socially Assistive Robot Activity | Usual Activity Program | Total |
|---|---|---|---|
| Female | 48 | 50 | 98 |
| Male | 23 | 21 | 44 |
| Ethnicity (NIH/OMB)(Participants) | Socially Assistive Robot Activity | Usual Activity Program | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 64 | 59 | 123 |
| Unknown or Not Reported | 7 | 10 | 17 |
| Race (NIH/OMB)(Participants) | Socially Assistive Robot Activity | Usual Activity Program | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 4 | 10 |
| White | 63 | 67 | 130 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All IPD that are de-identified and have been used in publications.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: 12 months after publications
Ran from Feb 2023 to primary completion in Oct 2025, 32 months.
Results were first posted in Oct 2026, 11 months after primary completion.
Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's 32 months is close to that.
Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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