User-Led Meaningful Activity and Early-Stage Dementia
NCT05159869, Not applicable, Completed, Johns Hopkins University; results first posted 2026-01-12
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | User-Led Meaningful Activity and Early-Stage Dementia | ClinicalTrials.gov |
| NCT number | NCT05159869 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 61 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Johns Hopkins University | ClinicalTrials.gov |
| Conditions | Dementia | ClinicalTrials.gov |
| Interventions | User-Led Meaningful Activity Plan | ClinicalTrials.gov |
| First posted | 2021-12-16 | ClinicalTrials.gov |
| Last updated | 2026-01-12 | ClinicalTrials.gov |
| Results first posted | 2026-01-12 | ClinicalTrials.gov |
Registered outcomes 26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Global Cognitive Function as Assessed by the Wechsler Memory Scale-III | Baseline and 4 months | Global cognitive function will be measured by the Wechsler Memory Scale-III (WMS-III) information/orientation subtest, which assesses general personal information and orientation to person, place, and time. Scores range from 0-14, with higher scores indicating more intact global cognitive function. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean. | ClinicalTrials.gov |
| Primary | Change in the Cognitive Domain of Attention as Assessed by the Wechsler Adult Intelligence Scale-IV Digit Span Test | Baseline and 4 months | Attention will be assessed via the Wechsler Adult Intelligence Scale (WAIS-IV) digit span subtest total score, obtained by adding up the total score on Digit Span Forward, Digit Span Backward, and Digit Span Sequencing. For all 3 tests, range = 0-16, with higher scores indicating better attention. Total raw score range = 0-48. Every series on each digit span subtest consists of two trials, each of which is scored 1 or 0 points. Testing is discontinued when a zero is obtained on both trials of an item. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean. | ClinicalTrials.gov |
| Primary | Change in the Cognitive Domain of Processing Speed as Assessed by the Trail-Making Test Part A | Baseline and 4 months | Processing speed will be assessed via the Trail-Making Test Part A. Participants must draw lines connecting 25 numbered circles in sequential order within a maximum time of 150 seconds. The raw completion time in seconds is converted to age-normed T-scores to facilitate standardized interpretation. Lower T-scores indicate slower processing speed, whereas higher T-scores indicate faster processing speed. Regarding clinically relevant thresholds, T-scores are standardized scores with a mean of 50 and a standard deviation (SD) of 10. A T-score below 40 (i.e., 1 SD below the mean) may suggest mild impairment in processing speed. T-scores below 30 (i.e., 2 SDs below the mean) may reflect substantial processing speed dysfunction. T-scores above 60 reflect performance that is above average for the individual's normative peer group. The outcome is measured as a change in T-score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean. | ClinicalTrials.gov |
| Primary | Change in the Cognitive Domain of Executive Function as Assessed by the Trail-Making Test Part B | Baseline and 4 months | Executive function will be assessed via the Trail-Making Test Part B. Participants must draw lines connecting 13 numbered circles alternately with 12 letters of the alphabet, all in ascending order within a maximum time of 300 seconds. The raw completion time in seconds is converted to age-normed T-scores. Lower T-scores indicate potential deficits in executive function, and higher T-scores indicate more intact executive function. For clinically relevant thresholds, T-scores are standardized scores with a mean of 50 and a standard deviation (SD) of 10. A T-score below 40 (i.e., 1 SD below the mean) may suggest mild executive dysfunction. T-scores below 30 (i.e., 2 SDs below the mean) may reflect substantial executive dysfunction. T-scores above 60 reflect above average executive function for the individual's normative peer group. The outcome is measured as a change in T-score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates improvement in the group mean. | ClinicalTrials.gov |
| Primary | Change in the Cognitive Domain of Executive Function as Assessed by the Stroop Color-Word Test | Baseline and 4 months | Executive function will be assessed via the Stroop Color-Word Test, a 100-item word-color page where word meanings and ink colors are mismatched (score range = 0-100). The participant must name as many correct ink colors as possible within a time limit of 45 seconds. The number of items correctly named is the raw score, which is converted to a T-score based on normative data, with higher T-scores indicating better executive function. For clinically relevant thresholds, T-scores are standardized scores with a mean of 50 and a standard deviation (SD) of 10. A T-score below 40 (i.e., 1 SD below the mean) suggests mild executive dysfunction. T-scores below 30 (i.e., 2 SDs below the mean) suggests substantial executive dysfunction. T-scores above 60 reflect above average executive function for the individual's normative peer group. The outcome is measured as a change in T-score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean. | ClinicalTrials.gov |
| Primary | Change in the Cognitive Domain of Executive Function as Assessed by the Clock Drawing Test (CLOX1) | Baseline and 4 months | Executive function will be assessed via the Clock Drawing Test Part 1 (CLOX 1). Participants will be asked to draw a clock, put in all the numbers, and set the hands to a specific time. The results will be scored using the CLOX method, which specifically evaluates executive function. CLOX1 scores range from 0-15. Lower scores reflect greater impairment. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean. | ClinicalTrials.gov |
| Primary | Change in the Cognitive Domain of Immediate Memory and Learning as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Learning Subtest | Baseline and 4 months | Immediate memory and new learning will be assessed via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest of List Learning. In list learning, 10 semantically unrelated words are orally presented to the subject at a two-second rate. The subject is asked to repeat as many words as possible after each of four learning trials. A higher number of words recalled (range 0-40) indicate more intact immediate memory. Raw scores are converted to a scaled score and percentile rank based on normative data. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean. | ClinicalTrials.gov |
| Primary | Change in the Cognitive Domains of Memory and Learning as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Story Memory Subtest | Baseline and 4 months | Memory and new learning will be assessed via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest Story Memory. Story Memory is a twelve-item short story presented over two trials (score range: 0-24). The story is read aloud at a slow reading speed. After each presentation, the subject is asked to recall as much of the story as he or she can remember, with more items recalled indicating more intact immediate memory. A verbatim criterion is used. Raw scores are converted to a scaled score and percentile rank based on normative data. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean. | ClinicalTrials.gov |
| Primary | Change in the Cognitive Domain of Delayed Memory as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Recall Subtest | Baseline and 4 months | Delayed memory will be assessed via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest of List Recall. List Recall requires the participant to remember as many words (range 0-10) from the list learning test as possible after a delay, with a higher number of words recalled indicating more intact delayed recall. Raw scores are converted to a scaled score and percentile rank based on normative data. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean. | ClinicalTrials.gov |
| Primary | Change in the Cognitive Domain of Delayed Memory as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Recognition Subtest | Baseline and 4 months | Delayed memory will be assessed via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest of List Recognition. After the List Learning and List Recall tasks (immediate and delayed), the participant is presented with a series of yes/no recognition trials including target words from the original list and foils. One point is awarded for each correct yes/no answer (range = 0-20), with a higher number of words recognized indicating more intact delayed recall. Raw scores are converted to a scaled score and percentile rank based on normative data. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean. | ClinicalTrials.gov |
| Primary | Change in the Cognitive Domain of Delayed Memory as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Story Memory Subtest | Baseline and 4 months | Delayed memory will be assessed via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest of Story Recall. In Story Recall, participants are asked to recall as many specific details as possible from the story learned in the story memory subtest, with more details indicating more intact delayed recall. Raw scores are converted to a scaled score and percentile rank based on normative data. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean. | ClinicalTrials.gov |
| Primary | Change in the Cognitive Domain of Immediate Visual Memory as Assessed by the Rey-Osterrieth Complex Figure Test | Baseline and 4 months | Immediate visual (non-verbal) memory will be assessed via the Rey-Osterrieth Complex Figure (ROCF) test. Participants will first copy a complex geometric figure and then immediately reproduce it from memory. Scoring of drawings is based on the widely used 36-point scoring system, with higher scores indicating more intact immediate visual memory. Each of the 18 scoring units is scored based on accuracy and placement criteria. Raw scores are converted to a scaled score and percentile rank based on normative data. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean. | ClinicalTrials.gov |
| Primary | Change in the Cognitive Domain of Delayed Visual Memory as Assessed by the Rey-Osterrieth Complex Figure Test | Baseline and 4 months | Delayed visual (non-verbal) memory will be assessed via the Rey-Osterrieth Complex Figure (ROCF) test. Participants are asked to draw all the elements of the figure from the initial figure copy that he or she can recall without visual display of the figure. Scoring of drawings is based on the widely used 0-36-point scoring system (score range), with higher scores indicating more intact delayed visual memory. Each of the 18 scoring units is scored based on accuracy and placement criteria. Raw scores are converted to a scaled score and percentile rank based on normative data. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean. | ClinicalTrials.gov |
| Primary | Change in the Cognitive Domain of Language as Assessed by the Controlled Oral Word Association Test | Baseline and 4 months | Language, specifically verbal fluency, will be assessed via the Controlled Oral Word Association (COWA) test. Participants are asked to come up with as many words as possible that begin with a given letter within a one-minute time period. Participants are also instructed to exclude proper nouns, numbers, and the same word with a different suffix. Score range 0-36. The number of correct responses is totaled, with higher numbers indicating greater verbal fluency, and the sum compared with normative data. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean. | ClinicalTrials.gov |
| Primary | Change in the Cognitive Domain of Language as Assessed by the Boston Naming Test | Baseline and 4 months | Language will be assessed via the Boston Naming Test (BNT). Participants are asked to name 60 line drawings of objects of graded difficulty, ranging from very common objects to less familiar ones. Objects must be spontaneously named within a 20-second period. If time limit expires, two kinds of prompting cues (one phonemic, one semantic) may be given. Rules allow for discontinuation and for starting the test at an advanced level, thus saving considerable time for subjects without obvious impairment. The examiner will then total the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. Score range 0-60. A higher number of correct spontaneous responses indicates more intact language skills. Scores will be compared to normative data. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean. | ClinicalTrials.gov |
| Primary | Change in the Cognitive Domain of Language as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Semantic Fluency | Baseline and 4 months | Language will be assessed via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) semantic fluency subtest. This test involves the generation of as many unique examples as possible from a given semantic category within 60 seconds. Raw scores typically range from 0 to approximately 30-40, depending on age and clinical status, with higher scores indicating better performance (i.e., greater language fluency and semantic access). The outcome is reported as a change in group mean T2 (4 months) - T1 (baseline), where the raw score is defined as the total number of valid, non-redundant examples generated on the RBANS Semantic Fluency subtest. A positive value indicates improved semantic fluency. | ClinicalTrials.gov |
| Primary | Change in the Cognitive Domain of Visuospatial Constructional Ability as Assessed by the Rey-Osterrieth Complex Figure Test | Baseline and 4 months | Visuospatial constructional ability is assessed using the Rey-Osterrieth Complex Figure (ROCF) test, a neuropsychological task in which participants reproduce a complex geometric figure. Scoring uses the standard 36-point system, in which 18 components are rated for accuracy and placement (0-2 points each). The total raw score ranges from 0 to 36, with higher scores indicating better performance. The outcome is reported as a change in mean raw score from baseline (T1) to 4 months (T2). A positive change score reflects improvement in visuospatial constructional ability. | ClinicalTrials.gov |
| Primary | Change in the Frequency x Severity of Neuropsychiatric Symptoms in Persons With Dementia as Assessed by the Neuropsychiatric Inventory (NPI) | Baseline and 4 months | Frequency and severity of neuropsychiatric symptoms are measured by the Neuropsychiatric Inventory (NPI) as reported by the primary caregiver. The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as 1 = occasionally, 2 = often, 3 = frequently, 4 = very frequently. Symptom severity is rated as 1= mild, 2 = moderate, 3 = marked. The total score is calculated as a sum of all 12 domain scores and thus ranges from 12 to 144, with a higher score indicating worsening symptoms. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a negative mean indicates an improvement in frequency x severity of symptoms. | ClinicalTrials.gov |
| Primary | Change in the Cognitive Domain of Visuospatial Ability as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Line Orientation | Baseline and 4 months | Visuospatial ability is assessed using the Line Orientation subtest of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). In this task, participants are asked to match two angled lines to corresponding lines from a semicircular fan of 13 lines. The test includes 10 trials, and each correct match is awarded 2 points, for a total raw score range of 0 to 20. Higher scores indicate better visuospatial performance. The outcome is reported as a change in mean raw score from baseline (T1) to 4 months (T2). A positive score reflects improved visuospatial ability. | ClinicalTrials.gov |
| Secondary | Change in Depression as Assessed by the Geriatric Depression Scale | Baseline and 4 months | Depression in persons with dementia will be measured by the Geriatric Depression Scale (GDS-15). The GDS-15 is a 15-item self-report scale tested and used extensively with older adults. Scores of 0-4 are considered normal, while scores of 5-8 signify mild depression, 9-11 signify moderate depression, and 12-15 indicate severe depression. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a negative mean indicates an improvement in depressive symptoms. | ClinicalTrials.gov |
Outcomes 26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change in Global Cognitive Function as Assessed by the Wechsler Memory Scale-III | Baseline and 4 months | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in the Cognitive Domain of Attention as Assessed by the Wechsler Adult Intelligence Scale-IV Digit Span Test | Baseline and 4 months | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in the Cognitive Domain of Processing Speed as Assessed by the Trail-Making Test Part A | Baseline and 4 months | T-score | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in the Cognitive Domain of Executive Function as Assessed by the Trail-Making Test Part B | Baseline and 4 months | T-score | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in the Cognitive Domain of Executive Function as Assessed by the Stroop Color-Word Test | Baseline and 4 months | T-score | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in the Cognitive Domain of Executive Function as Assessed by the Clock Drawing Test (CLOX1) | Baseline and 4 months | units on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in the Cognitive Domain of Immediate Memory and Learning as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Learning Subtest | Baseline and 4 months | units on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in the Cognitive Domains of Memory and Learning as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Story Memory Subtest | Baseline and 4 months | units on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in the Cognitive Domain of Delayed Memory as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Recall Subtest | Baseline and 4 months | Participants with data collected | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change in the Cognitive Domain of Delayed Memory as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Recognition Subtest | Baseline and 4 months | units on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in the Cognitive Domain of Delayed Memory as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Story Memory Subtest | Baseline and 4 months | units on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in the Cognitive Domain of Immediate Visual Memory as Assessed by the Rey-Osterrieth Complex Figure Test | Baseline and 4 months | units on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in the Cognitive Domain of Delayed Visual Memory as Assessed by the Rey-Osterrieth Complex Figure Test | Baseline and 4 months | units on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in the Cognitive Domain of Language as Assessed by the Controlled Oral Word Association Test | Baseline and 4 months | units on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in the Cognitive Domain of Language as Assessed by the Boston Naming Test | Baseline and 4 months | units on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in the Cognitive Domain of Language as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Semantic Fluency | Baseline and 4 months | examples | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in the Cognitive Domain of Visuospatial Constructional Ability as Assessed by the Rey-Osterrieth Complex Figure Test | Baseline and 4 months | points | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in the Frequency x Severity of Neuropsychiatric Symptoms in Persons With Dementia as Assessed by the Neuropsychiatric Inventory (NPI) | Baseline and 4 months | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in the Cognitive Domain of Visuospatial Ability as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Line Orientation | Baseline and 4 months | points | MEAN | ClinicalTrials.gov | |
| SECONDARY | Change in Depression as Assessed by the Geriatric Depression Scale | Baseline and 4 months | score on a scale | MEAN | ClinicalTrials.gov |
Results by group 52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change in Global Cognitive Function as Assessed by the Wechsler Memory Scale-III | Experimental | -0.2 | Standard Deviation 0.8 | score on a scale | ClinicalTrials.gov | |
| Change in Global Cognitive Function as Assessed by the Wechsler Memory Scale-III | Wait-List Control | -0.2 | Standard Deviation 0.9 | score on a scale | ClinicalTrials.gov | |
| Change in the Cognitive Domain of Attention as Assessed by the Wechsler Adult Intelligence Scale-IV Digit Span Test | Experimental | 0.6 | Standard Error 0.3 | score on a scale | ClinicalTrials.gov | |
| Change in the Cognitive Domain of Attention as Assessed by the Wechsler Adult Intelligence Scale-IV Digit Span Test | Wait-List Control | -0.2 | Standard Error 0.3 | score on a scale | ClinicalTrials.gov | |
| Change in the Cognitive Domain of Processing Speed as Assessed by the Trail-Making Test Part A | Experimental | 2.6 | Standard Deviation 6.4 | T-score | ClinicalTrials.gov | |
| Change in the Cognitive Domain of Processing Speed as Assessed by the Trail-Making Test Part A | Wait-List Control | -0.2 | Standard Deviation 6.7 | T-score | ClinicalTrials.gov | |
| Change in the Cognitive Domain of Executive Function as Assessed by the Trail-Making Test Part B | Experimental | 2.7 | Standard Deviation 7.6 | T-score | ClinicalTrials.gov | |
| Change in the Cognitive Domain of Executive Function as Assessed by the Trail-Making Test Part B | Wait-List Control | -0.6 | Standard Deviation 7.2 | T-score | ClinicalTrials.gov | |
| Change in the Cognitive Domain of Executive Function as Assessed by the Stroop Color-Word Test | Experimental | 1.1 | Standard Deviation 6.9 | T-score | ClinicalTrials.gov | |
| Change in the Cognitive Domain of Executive Function as Assessed by the Stroop Color-Word Test | Wait-List Control | 0.4 | Standard Deviation 5.8 | T-score | ClinicalTrials.gov | |
| Change in the Cognitive Domain of Executive Function as Assessed by the Clock Drawing Test (CLOX1) | Experimental | 1.3 | Standard Deviation 1.9 | units on a scale | ClinicalTrials.gov | |
| Change in the Cognitive Domain of Executive Function as Assessed by the Clock Drawing Test (CLOX1) | Wait-List Control | 0.2 | Standard Deviation 2.2 | units on a scale | ClinicalTrials.gov | |
| Change in the Cognitive Domain of Immediate Memory and Learning as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Learning Subtest | Experimental | 2.7 | Standard Deviation 4.6 | units on a scale | ClinicalTrials.gov | |
| Change in the Cognitive Domain of Immediate Memory and Learning as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Learning Subtest | Wait-List Control | 0.1 | Standard Deviation 4.4 | units on a scale | ClinicalTrials.gov | |
| Change in the Cognitive Domains of Memory and Learning as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Story Memory Subtest | Experimental | 1.8 | Standard Deviation 3.4 | units on a scale | ClinicalTrials.gov | |
| Change in the Cognitive Domains of Memory and Learning as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Story Memory Subtest | Wait-List Control | 0.3 | Standard Deviation 3.2 | units on a scale | ClinicalTrials.gov | |
| Change in the Cognitive Domain of Delayed Memory as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Recall Subtest | Experimental | 1.2 | Standard Deviation 2.0 | units on a scale | ClinicalTrials.gov | |
| Change in the Cognitive Domain of Delayed Memory as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Recall Subtest | Wait-List Control | 0.2 | Standard Deviation 2.1 | units on a scale | ClinicalTrials.gov | |
| Change in the Cognitive Domain of Delayed Memory as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Recognition Subtest | Experimental | 1.1 | Standard Deviation 2.3 | units on a scale | ClinicalTrials.gov | |
| Change in the Cognitive Domain of Delayed Memory as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Recognition Subtest | Wait-List Control | 0.2 | Standard Deviation 2.3 | units on a scale | ClinicalTrials.gov |
Participant flow 10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Experimental Group - Individuals With Dementia | 31 | ClinicalTrials.gov | |
| Overall Study | STARTED | Wait-List Control Group - Individuals With Dementia | 30 | ClinicalTrials.gov | |
| Overall Study | Caregivers (Not Enrolled) | Experimental Group - Individuals With Dementia | 31 | ClinicalTrials.gov | |
| Overall Study | Caregivers (Not Enrolled) | Wait-List Control Group - Individuals With Dementia | 30 | ClinicalTrials.gov | |
| Overall Study | Individuals With Dementia | Experimental Group - Individuals With Dementia | 31 | ClinicalTrials.gov | |
| Overall Study | Individuals With Dementia | Wait-List Control Group - Individuals With Dementia | 30 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Experimental Group - Individuals With Dementia | 31 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Wait-List Control Group - Individuals With Dementia | 30 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Experimental Group - Individuals With Dementia | 0 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Wait-List Control Group - Individuals With Dementia | 0 | ClinicalTrials.gov |
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Experimental | 0 | 31 | ClinicalTrials.gov |
| Total, all-cause mortality | Wait-List Control | 0 | 30 | ClinicalTrials.gov |
| Total, other adverse events | Experimental | 0 | 31 | ClinicalTrials.gov |
| Total, other adverse events | Wait-List Control | 0 | 30 | ClinicalTrials.gov |
| Total, serious adverse events | Experimental | 0 | 31 | ClinicalTrials.gov |
| Total, serious adverse events | Wait-List Control | 0 | 30 | ClinicalTrials.gov |
Papers 4
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Experimental vs Wait-List Control: deaths from any cause | Trial comparisons |
| Experimental vs Wait-List Control: serious adverse events | Trial comparisons |
Tests 10
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Primary outcome | ConductCognition |
| Clock Drawing Task | Primary outcome | ConductCognition |
| Complex Figure Copy and Recall | Primary outcome | ConductCognition |
| Digit Span Test | Primary outcome | ConductCognition |
| Picture Naming Test | Primary outcome | ConductCognition |
| Short Story Recall | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)