Alzheimer Disease
Conditions
Brief summary
A 12-month pilot study will be comprised of two groups of people diagnosed with mild Alzheimer's disease and related dementia for a total of 80 senior subjects. Subjects will be randomly assigned to two groups: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day. Group 2 (Active Control Group) will play solitary games and activities but will have to interaction with Ryan. The team will measure the changes and improvement in the social/emotional well-being of these two groups and eventual changes in the cognitive/memory functions of elderly people living in the similar environment.
Interventions
BEHAVIORALPlay Serious Games with a Social Robot (Ryan)
Active Group: Game play and physical activities with Ryan, a socially assistive robot developed at DreamFace Technologies,LLC.
BEHAVIORALPlay Solitary Games Without a Social Robot
Control Group: Group 2 will play solitary games (e.g., word puzzles) and activities but will have no interaction with Ryan.
Sponsors
National Institute on Aging (NIA)
DreamFace Technologies, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
A 12-month pilot study will be comprised of two groups of people diagnosed with mild Alzheimer's disease and related dementia for a total of 80 senior subjects. Subjects will be randomly assigned to two groups: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day. Group 2 (Active Control Group) will play solitary games and activities but will have to interaction with Ryan. The team will measure the changes and improvement in the social/emotional well-being of these two groups and eventual changes in the cognitive/memory functions of elderly people living in the similar environment.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 65 years * Early Alzheimer's disease and related dementia diagnosed by a qualified provider * Saint Louis University Mental Status (SLUMS) score between 10 and 25 * Resident of assisted living facility for at least one month prior and for the duration of the study * Deemed conditioned enough to participate in physical activities after a wellness check * Verbal skill to interact * Participant or Legal decision
Exclusion criteria
Aggressive behavior * Diagnosed with severe dementia or memory loss * Acute physical illness that impairs ability to participate * Patients with serious comorbidity, tumors and other diseases casually related to cognitive impairment * History of alcohol or drug abuse, head trauma, psychoactive substance use and other causes of memory impairment * Significant sensory impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive/Memory Ability | assessed at baseline (week 1), week 4, and 8. Week 8 reported. | Participants will complete the Saint Louis University Mental Status (SLUMS) test, a screening method for Alzheimer's and other dementia. Scores range from 0 to 30. Scores of 27 to 30 are considered normal in a person with a high school education. Scores between 21 and 26 suggest a mild neurocognitive disorder. Scores between 0 and 20 indicate dementia. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Control Group: Group 2 users will play solitary games (word puzzles) and activities but will have no interaction with Ryan.
Play Solitary Games Without a Social Robot: Control Group: Group 2 will play solitary games (e.g., word puzzles) and activities but will have no interaction with Ryan. | 4 |
| Active Group Active Group: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day.
Play Serious Games with a Social Robot (Ryan): Active Group: Game play and physical activities with Ryan, a socially assistive robot developed at DreamFace Technologies,LLC. | 18 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Active Group | Total | Control Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 22 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 76.2 Year STANDARD_DEVIATION 6.11 | 77.7 Year STANDARD_DEVIATION 6.43 | 80.20 Year STANDARD_DEVIATION 5.44 |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 15 Participants | 19 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 2 Participants | 2 Participants | 0 Participants |
| Region of Enrollment United States | 18 Participants | 22 Participants | 4 Participants |
| Sex: Female, Male Female | 12 Participants | 15 Participants | 3 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 1 Participants |
| The Saint Louis University Mental Status (SLUMS) | 21.12 units on a scale STANDARD_DEVIATION 3.2 | 20.45 units on a scale STANDARD_DEVIATION 3.34 | 19.12 units on a scale STANDARD_DEVIATION 4.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 18 |
| other Total, other adverse events | 0 / 4 | 0 / 18 |
| serious Total, serious adverse events | 0 / 4 | 0 / 18 |
Outcome results
Primary
Change in Cognitive/Memory Ability
Participants will complete the Saint Louis University Mental Status (SLUMS) test, a screening method for Alzheimer's and other dementia. Scores range from 0 to 30. Scores of 27 to 30 are considered normal in a person with a high school education. Scores between 21 and 26 suggest a mild neurocognitive disorder. Scores between 0 and 20 indicate dementia.
Time frame: assessed at baseline (week 1), week 4, and 8. Week 8 reported.
Population: The participants did not complete the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Group | Change in Cognitive/Memory Ability | 23.75 score on a scale | Standard Deviation 3.45 |