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| ID | Type | Description | Link |
|---|---|---|---|
| 2SB1AG037357-04A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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Cognitive impairment is a significant health problem in the United States, resulting in costs over $100 billion a year. We will provide an efficient, effective, and financially intelligent solution to Primary Care Physician's to identify cognitive impairment in the earliest stages, delay progression through appropriate treatment, and to afford patients the opportunity to make future plans at a time when symptoms are mild and patients are able to make informed decisions concerning financial and life activities. This has the potential to delay devastating effects of cognitive impairment, and to lessen the financial burden on the health care system in the United States.
Cognitive dysfunction in the elderly population, ranging from simple forgetfulness to a diagnosis of Alzheimer's disease, can impact one's quality of life and ability to function in daily activities. It is crucial that decline be detected as early as possible in order to evaluate whether the cause is treatable, and to employ appropriate treatment, if applicable. The majority of older patients rely on their primary care physician for the bulk of their healthcare needs, but there is a lack of sensitive tools available, and there is a lack of physician's time to use the tools, leading to a failure to provide therapeutic intervention at the earliest stages of loss to potentially slow the progression of disease. Psychology Software Tools, Inc. (PST) has developed the Computer Assessment of Memory and Cognitive Impairment (CAMCI), a computerized screening tool for detection of early signs of cognitive decline, which has been shown to be more effective in the identification of patients with subtle cognitive loss than the tools most frequently used within the primary care physician (PCP) office. CAMCI would provide an option for PCPs and clinicians to provide therapeutic intervention prior to a diagnosis of dementia. Recent additions to Current Procedural Terminology (CPT) codes permit insurance reimbursement for neuropsychological testing by a computer, including time for the physician's or clinical psychologist's interpretation and reporting. The introduction of this new revenue stream for PCPs and clinicians, coupled with the characteristics of being brief and self-administered make CAMCI an attractive option for improving early intervention, providing an intelligent business solution for healthcare professionals, and a useful and effective tool that allows physicians to better evaluate and serve their patients. The specific aims included in the current project focus on activities required to successfully move CAMCI to commercialization by extending support for late stage research and product development, including regulatory strategy and intellectual property development, data collection to replicate key studies, product extension through increasing minority representation, and development of a measure of meaningful change. The ultimate goal is to streamline commercialization of CAMCI, and to provide a useful and effective tool in the detection of cognitive dysfunction to physicians, the providers of the majority of healthcare to the elderly population, to improve efficiency and effectiveness of clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAMCI Validation | Experimental | Completion of computerized tasks (Computer Assessment of Memory and Cognitive Impairment) and traditional neuropsychological tests administered via paper-pencil method by a trained administrator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAMCI | Device | CAMCI is a computerized screening tool for the assessment of cognitive status. CAMCI accurately assesses cognitive performance using standard neuropsychological tests of memory, attention, and executive ability modified for computer administration, and an innovative Virtual Environment task, testing domains such as incidental memory, not easily assessed using paper-pencil tests. Computer-administered tasks ensure standard administration and scoring, avoiding inter-site and inter-examiner variability. The CAMCI battery consists of tasks testing multiple aspects of cognitive function, and a series of self-report questions administered via tablet computer. Using touchscreen technology for response input, CAMCI takes approximately 15-20 minutes to complete. |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement Analysis (Agreement to Reference Standard) - Test Group | Comparison (positive and negative percent agreement, confidence interval estimates, and quadratic weighted kappa) between CAMCI and clinical adjudication classifications for the Test group. Power calculations for agreement were assessed for Cohen Kappa's assuming at least 75% Normals with 80% power and .05 significance level, finding that we were sufficiently powered with at least 120 individuals in the test set, for a Kappa of at least 0.3. | baseline |
| Agreement Analysis (Agreement to Non-Reference Standard) - Test Group | Linear regression agreement analysis (linear regression equation and confidence intervals, and Pearson correlation) between CAMCI and Montreal Cognitive Assessment (MoCA) for the Test group. Comparison (positive and negative percent agreement, confidence interval estimates, and quadratic weighted kappa) between CAMCI and Montreal Cognitive Assessment (MoCA) for the Test group. CAMCI Scores ranged from 0-50, higher scores mean better outcome. MoCA scores ranged from 0-30, higher scores mean better outcome. Power calculations for agreement were assessed for Cohen Kappa's assuming at least 75% Normals with 80% power and .05 significance level, finding that we were sufficiently powered with at least 120 individuals in the test set, for a Kappa of at least 0.3. | baseline |
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| Measure | Description | Time Frame |
|---|---|---|
| Change Metric (Measure of Significant Change) | To derive a measure of reliable change that addressed unbalanced repeated measures and unequal timing of repeat measures, we built a two-stage hierarchical model for longitudinal data using Bayesian methods. Additionally, the standard deviation (SD) was allowed to change over time, which allowed for computation of an intraclass correlation coefficient (ICC), a measure of reliability. With an SD and ICC that can change over time, reliable change was computed for follow-up months from 3 to 24, in groups of 3. Reliable change was then adjusted for practice effects according to Duff, K. (2012). Computer Assessment of Memory and Cognitive Impairment (CAMCI) scores were calculated as the weighted sum of individual task scores converted to a total score from 0-worst to 50-best. As the intended use of CAMCI is to provide a single score of overall cognitive status, individual task scores were not reported. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Zuccolotto | Psychology Software Tools | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States | ||
| Psychology Software Tools |
Quality-controlled raw data as well as processed data used in publications will be made available. Shared data will include computerized task scores, neuropsychological test scores, and full analytical codes used to process and analyze the data. Workflows will be described and documented to allow replication of results from the raw data.
Data and corresponding documentation will be made available through Open Science Framework, in addition to any potential requirements on software sharing by journals.
The PI or Co-Investigators will disseminate results from this research through presentations at public lectures, scientific institutions and meetings, and/or publication in major journals. The PI and Co-Investigators will adhere to the NIH Grants Policy on Sharing of Unique Research Resources including the Sharing of Biomedical Research Resources: Guidelines for Recipients of NIH Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources.
Data will be deposited into the repository indicated above as soon as possible, but no later than 4 years after the end of the award project period.
The Small Business Act provides authority for NIH to protect from disclosure and nongovernmental use all Small Business Innovative Research (SBIR) data developed from work performed under an SBIR funding agreement for a period of 4 years after the closeout of either a phase I or phase II grant unless NIH obtains permission from the awardee to disclose these data. The data rights protection period lapses only upon expiration of the protection period applicable to the SBIR award, or by agreement between the small business concern and NIH.
PST will identify where the data will be available and how to access the data in any publications and presentations about these data, as well as acknowledge the repository and funding source in any publications and presentations. In addition, PST will abide by the policies and procedures required by the repository indicated above, fully consistent with NIH data sharing policies and applicable laws and regulations.
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| ID | Title | Description |
|---|---|---|
| FG000 | CAMCI Validation | Validation of the Computer Assessment of Memory and Cognitive Impairment (CAMCI) against 1) clinical adjudication of traditional neuropsychological tests administered via paper and pencil and 2) the Montreal Cognitive Assessment (MoCA) tool for early detection of mild cognitive impairment (MCI) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CAMCI Validation | Validation of the Computer Assessment of Memory and Cognitive Impairment (CAMCI) against 1) clinical adjudication of traditional neuropsychological tests administered via paper and pencil and 2) the Montreal Cognitive Assessment (MoCA) tool for early detection of mild cognitive impairment (MCI) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 60 years or older |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Agreement Analysis (Agreement to Reference Standard) - Test Group | Comparison (positive and negative percent agreement, confidence interval estimates, and quadratic weighted kappa) between CAMCI and clinical adjudication classifications for the Test group. Power calculations for agreement were assessed for Cohen Kappa's assuming at least 75% Normals with 80% power and .05 significance level, finding that we were sufficiently powered with at least 120 individuals in the test set, for a Kappa of at least 0.3. | Test group. Of 773 participants enrolled, 9 were excluded, leaving 764 for analysis. Participants who completed CAMCI version A at baseline (N=680) were assigned through stratified random sampling to Training (75%) or Test (25%) groups, balanced by age, education, race, ethnicity, gender, and cognitive classification. The groups were further adjusted to match the racial and ethnic distribution in the U.S., resulting in a Training group (N=374) and a Test group (N=126). | Posted | Count of Participants | Participants | baseline |
|
24 months Participants were seen at baseline only, at baseline-6 months-12 months, or at baseline-12 months-24 months. Adverse events were collected from the time a participant was enrolled until scheduled sessions were completed according to the participant's assigned group (max 24 months). COVID interruptions and project extensions, the study lasted 4 years, 4 months. Adverse events were reviewed by the Data Safety Monitoring Board as appropriate during the entire study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CAMCI Validation | Computerized and paper-pencil neuropsychological tests, baseline CAMCI: CAMCI battery of computerized tasks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death unrelated to intervention reported by caregiver or test site | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Strain | General disorders | Non-systematic Assessment | One participant reported feeling tired and "strained" after completing the assessment but recovered without treatment. |
Baseline and Follow-Up assessment targets were not reached due to suspension of the trial during the COVID-19 pandemic. Sites prohibited in-person testing for a period of 6 months, resulting in withdrawal of subjects and loss of follow-up data according to the planned timeline. Additionally, after restart, the year 3 award restricted activities during the last 6 months of the project to analysis only, limiting testing duration. By design, the trial required 36 months to complete all follow-ups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony Zuccolotto | Psychology Software Tools, Inc. | 412-449-0078 | anthony.zuccolotto@pstnet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 13, 2018 | Feb 14, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 18, 2019 | Feb 14, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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|
|
| MoCA | Diagnostic Test | The Montreal Cognitive Assessment (MoCA) is a rapid screening tool used to detect mild cognitive impairment (MCI), assessing cognitive domains (visuospatial skills, executive function, memory, attention, language, and orientation). Individual test scores are summed into a total score from 0 (worst) to 30 (best). Individuals may achieve any score within that range. Individual test scores are not reported. Scores: 26-30 considered Normal; 19-25 may suggest Mild Cognitive Impairment (MCI); 10-18 can suggest moderate impairment; < 10 may indicate severe impairment |
|
|
| Clinical Adjudication | Diagnostic Test | Cognitive status assessed by traditional neuropsychological tests measuring visuospatial skills, executive function, memory, attention, language, orientation. Results compared to age-adjusted norms, reviewed by expert neuropsychologists for consensus classification, per Univ of Pittsburgh Alzheimers Disease Research Ctr and Ntl Alzheimers Coordinating Ctr, and Alzheimer's Assoc criteria. Final classification adjusted per clinical judgment. Impaired: ≥3 scores ≥2SD below norms Indeterminate: ≤2 scores >1SD below norms Normal: Neither criteria met. Total and domain scores not reported. |
|
|
| baseline, 6 months, 12 months, 24 months post baseline |
| Sharpsburg |
| Pennsylvania |
| 15215 |
| United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Virginia | Charlottesville | Virginia | 22904 | United States |
| Inadequate fluency with the English language |
|
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Neuropsychological classification | Cognitive status assessed by traditional neuropsychological tests measuring visuospatial skills, executive function, memory, attention, language, orientation. Results compared to age-adjusted norms, reviewed by expert neuropsychologists for consensus classification, per Univ of Pittsburgh Alzheimers Disease Research Ctr and Ntl Alzheimers Coordinating Ctr, and Alzheimer's Assoc criteria. Final classification adjusted per clinical judgment. Impaired: ≥3 scores ≥2SD below norms Indeterminate: ≤2 scores >1SD below norms Normal: Neither criteria met. Total and domain scores not reported. | Count of Participants | Participants |
|
| Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment (MoCA) is a rapid screening tool to detect mild cognitive impairment (MCI), assessing cognitive domains (visuospatial skills, executive function, memory, attention, language, and orientation). Individual subtest scores are summed for a total score from 0 (worst) to 30 (best). Individuals may achieve any score within that range. Individual subtest scores are not reported. Score range with Classification: 26-30 considered Normal; 19-25 may suggest Mild Cognitive Impairment (MCI); 10-18 can suggest moderate impairment; < 10 may indicate severe impairment | Count of Participants | Participants |
|
| CAMCI | CAMCI (Computer Assessment of Memory and Cognitive Impairment) is a screening tool for assessment of cognitive status using neuropsychological tests of memory, attention, executive ability modified for computer administration, and a Virtual Environment task assessing cognitive areas not easily assessed by paper tests. Score is a weighted sum of individual task scores converted to total score from 0-worst to 50-best. Intended use provides single score/cognitive classification. Individual task scores not reported. Score Range with Classification: 21-50=Normal, 16-20=Indeterminate, 0-15=Impaired | Count of Participants | Participants |
|
| WRAT5 - Word Reading | The Wide Range Achievement Test, 5th Edition (WRAT5), Word Reading test assess fundamental reading skills and can indicate cognitive impairments affecting academic performance. Participant reads aloud a list of letters (15) and words (55). One point for each letter or word read correctly. Higher scores are better. Score range 0-70 points. | Mean | Standard Deviation | points |
|
| WAIS-IV Digit Span Forward | The Digit Span Forward (DSF) (Wechsler et al., 1987), part of the Wechsler Adult Intelligence Scale, 4th Edition (WAIS-IV) evaluates short-term memory and attention. Examiner reads a span of digits at a rate of one digit per second. Participant must repeat the digits back to the examiner in sequential (forward) order. Two trials are presented at each span length. The length of span is increased (Max Span 0-9) if at least 1 correct response given at the current span length. A point is awarded for each correct recall. Score is the total points obtained (0-16). Higher scores are better. | Mean | Standard Deviation | points |
|
| WAIS-IV Digit Span Backward | The Digit Span Backward (DSB) (Wechsler et al., 1987), part of the Wechsler Adult Intelligence Scale, 4th Edition (WAIS-IV) evaluates working memory and cognitive flexibility. Examiner reads a span of digits at a rate of one digit per second. Participant must repeat the digits back to the examiner in reverse (backward) order. Two trials are presented at each span length. The length of span is increased (Max Span 0-8) if at least 1 correct response given at the current span length. A point is awarded for each correct recall. Score is the total points obtained (0-16). Higher scores are better. | Mean | Standard Deviation | points |
|
| WMS-IV Logical Memory I - Immediate Recall | The Logical Memory I, part of the Wechsler Memory Scale, 4th Edition (WMS-IV), Wechsler (1987), evaluates immediate verbal memory recall and the ability to encode and retrieve information quickly. Participant is read 2 short stories selected by age (Adult=60-69 years old, Older Adult=65-90 years old) and asked to recall as many details as possible immediately after hearing each story. Score is the number of details correctly recalled (1 point per correct detail.) Scores range based on story complexity (0-14, or 0-25). Story scores are summed for a Total Score. | The standardized test is provided in two forms that are selected based on participant age and ability. The age groups for this study are adults ages 60 to 69 years old and older adults ages 65 to 90 years old. There were 355 participants assigned to the adult group and 409 participants assigned to the older adult group. | Mean | Standard Deviation | points |
|
| WMS-IV Logical Memory II - Delayed Recall | The Logical Memory II, part of the Wechsler Memory Scale, 4th Edition (WMS-IV), Wechsler (1987), evaluates delayed memory recall, which involves the ability to store information and retrieve it after a period of time. Participant is read 2 short stories selected by age (Adult=60-69 years old, Older Adult=65-90 years old). After a delay of ~30 minutes, participant is asked to recall as many details as possible. Score is the number of details correctly recalled (1 point per correct detail.) Scores range based on story complexity (0-14, or 0-25). Story scores are summed for a Total Score. | The standardized test is provided in two forms that are selected based on participant age and ability. The age groups for this study are adults ages 60 to 69 years old and older adults ages 65 to 90 years old. There were 355 participants assigned to the adult group and 409 participants assigned to the older adult group. | Mean | Standard Deviation | points |
|
| Rey-Osterrieth Complex Figure Test (ROCF) | The Rey-Osterrieth Complex Figure Test (ROCF) (Meyers and Meyers, 1995), evaluates visuospatial abilities, memory, attention, and executive functions. Participant is presented with a complex geometric figure to study then reproduce the figure on a blank sheet of paper. After ~3 minutes (immediate recall) and ~30 minutes (delayed recall) participant must reproduce the figure again from memory. Each reproduction is scored based on 18 design elements with 0, .5, 1, or 2 points awarded per element based on element accuracy and placement. | Mean | Standard Deviation | points |
|
| Letter Fluency (F-A-S) Test | The Letter Fluency (F-A-S) Test, a subtest of the Neurosensory Center Comprehensive Examination for Aphasia (Spreen and Benton, 1977) evaluates phonemic verbal fluency and can assess language abilities, executive functions, and cognitive flexibility. Participant is asked to generate as many words as possible that begin with the letters "F," "A," and "S" within 60 seconds for each letter. Score is total words generated (1 point per unique word) within the time limit. Higher scores are better. There is no fixed upper limit of the score. | Mean | Standard Deviation | points |
|
| Semantic Fluency Test (Animals) | The Semantic Fluency Test (animals) (Spreen and Strauss, 1997), evaluates semantic memory, language abilities, and executive functions, including cognitive flexibility and retrieval from long-term memory. Participant is asked to name as many animals as they can within 60 seconds. Score is total animal names generated (1 point per unique animal named) within the time limit. Higher scores are better. There is no fixed upper limit of the score. | Mean | Standard Deviation | points |
|
| Hopkins Verbal Learning Test - Revised (HVLT-R) - Recall | The Hopkins Verbal Learning Test - Revised (HVLT-R) evaluates verbal learning and memory. Participant is presented with a list of 12 nouns, 4 words each from 3 semantic categories and asked to recall them over a series of 3 Learning Trials. Score ranges 0-12 on each trial (1 point per each correct word). The score from each trial is summed for a Learning Trials Total Recall Score (0-36). After a 20 minute delay, the participant performs a final recall for a Delayed Recall Score (0-12). Higher is better for all scores. Retention % = Delayed Recall score / high score from Learning Trials 2 or 3. | Mean | Standard Deviation | points |
|
| Hopkins Verbal Learning Test - Revised (HVLT-R) - Retention % | The Hopkins Verbal Learning Test - Revised (HVLT-R) evaluates verbal learning and memory. Participant is presented 12 nouns, 4 words each from 3 semantic categories and asked to recall them over a series of 3 Learning Trials. Score ranges 0-12 on each trial (1 point per correct word). The score from each trial is summed for a Learning Trials Total Recall Score (0-36). After a 20 minute delay, participant performs a final recall for a Delayed Recall Score (0-12). Retention % = Delayed Recall score / high score from Learning Trials 2 or 3. Higher Retention % is better, as is not capped to 100%. | Mean | Standard Deviation | percentage |
|
| Trail Making Test - Score | The Trail Making Test (TMT) (Reitan et al., 1958) evaluates processing speed, attention, and executive function. Participant draws lines as instructed to connect 25 circles labeled with numbers or letters without lifting the pen. One point awarded per correct line drawn (0-24, higher is better.) Task completion time is recorded in seconds. In Part A participant has 150 seconds to connect the numbered circles in ascending order (1-2-3, etc.). In Part B participant has 300 seconds to connect 25 circles alternating between numbers and letters in ascending order (1-A-2-B, etc.) | Mean | Standard Deviation | points |
|
| Hopkins Verbal Learning Test - Revised (HVLT-R) - Recognition | The Hopkins Verbal Learning Test - Revised (HVLT-R) evaluates verbal learning and memory. Participant is presented 12 nouns and asked to recall them over 3 Learning Trials followed by a 20 minute Delayed Recall. Participant is then presented 12 target + 12 distractor words (6 semantically related, 6 semantically unrelated) and asked to recognize any prior words presented. Retention % = Delayed Recall score divided by high score from Learning Trials 2 or 3. Retention Discrimination Index (-12 to 12) is calculated as number of true-positives - number of false positives. Higher scores are better. | Mean | Standard Deviation | count |
|
| Trail Making Test - Completion Time | The Trail Making Test (TMT) (Reitan et al., 1958) evaluates processing speed, attention, and executive function. Participant draws lines as instructed to connect 25 circles labeled with numbers or letters without lifting the pen. One point awarded per correct line drawn (0-24, higher is better.) Task completion time is recorded in seconds. In Part A participant has 150 seconds to connect the numbered circles in ascending order (1-2-3, etc.). In Part B participant has 300 seconds to connect 25 circles alternating between numbers and letters in ascending order (1-A-2-B, etc.) | Mean | Standard Deviation | time in seconds |
|
| WAIS-IV Digit Symbol Substitution Test (DSST) | The Digit Symbol Substitution Test (DSST) part of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) (Wechsler et al., 1987) evaluates processing speed, attention, and motor skills. Performance correlates with real-world functional outcomes e.g., ability to accomplish everyday tasks. Participant is given a sheet of numbers and a key showing a unique symbol corresponding to each number. Participants match symbols to numbers by copying the correct symbol into spaces below each number within 120 seconds. Higher scores are better. Score range 0-135, 1 point for each correct symbol matched. | Mean | Standard Deviation | points |
|
| Boston Naming Test | The Boston Naming Test (BNT) 2nd edition (Kaplan et al., 2000) evaluates language abilities, specifically confrontation naming. Participant is shown 60 black-and-white line drawings of objects, one at a time for up to 20 seconds and asked to name each object. If participant struggles to name an object, examiner can provide a stimulus cue (descriptive) and a phonemic cue (sound-based). Score is the number of correct responses, including those given after a stimulus cue but excluding those given after a phonemic cue. Scores range from 0-60. Higher scores are better. | Mean | Standard Deviation | points |
|
| OG000 |
| Clinical Adjudication - Normal |
Participants classified as Normal through clinical adjudication. |
| OG001 | Clinical Adjudication - Indeterminate | Participants classified as Indeterminate through clinical adjudication. |
| OG002 | Clinical Adjudication - Impaired | Participants classified as Impaired through clinical adjudication. |
|
|
|
| Primary | Agreement Analysis (Agreement to Non-Reference Standard) - Test Group | Linear regression agreement analysis (linear regression equation and confidence intervals, and Pearson correlation) between CAMCI and Montreal Cognitive Assessment (MoCA) for the Test group. Comparison (positive and negative percent agreement, confidence interval estimates, and quadratic weighted kappa) between CAMCI and Montreal Cognitive Assessment (MoCA) for the Test group. CAMCI Scores ranged from 0-50, higher scores mean better outcome. MoCA scores ranged from 0-30, higher scores mean better outcome. Power calculations for agreement were assessed for Cohen Kappa's assuming at least 75% Normals with 80% power and .05 significance level, finding that we were sufficiently powered with at least 120 individuals in the test set, for a Kappa of at least 0.3. | Test group. Of 773 participants enrolled, 9 were excluded, leaving 764 for analysis. Participants who completed CAMCI version A at baseline (N=680) were assigned through stratified random sampling to Training (75%) or Test (25%) groups, balanced by age, education, race, ethnicity, gender, and cognitive classification. The groups were further adjusted to match the racial and ethnic distribution in the U.S., resulting in a Training group (N=374) and a Test group (N=126). | Posted | Count of Participants | Participants | baseline |
|
|
|
|
| Other Pre-specified | Change Metric (Measure of Significant Change) | To derive a measure of reliable change that addressed unbalanced repeated measures and unequal timing of repeat measures, we built a two-stage hierarchical model for longitudinal data using Bayesian methods. Additionally, the standard deviation (SD) was allowed to change over time, which allowed for computation of an intraclass correlation coefficient (ICC), a measure of reliability. With an SD and ICC that can change over time, reliable change was computed for follow-up months from 3 to 24, in groups of 3. Reliable change was then adjusted for practice effects according to Duff, K. (2012). Computer Assessment of Memory and Cognitive Impairment (CAMCI) scores were calculated as the weighted sum of individual task scores converted to a total score from 0-worst to 50-best. As the intended use of CAMCI is to provide a single score of overall cognitive status, individual task scores were not reported. | Individuals who received a consistent version of CAMCI across all visits (i.e., CAMCI-A), and were classified as Normal through clinical adjudication at all visits. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 6 months, 12 months, 24 months post baseline |
|
|
|
| 5 |
| 773 |
| 6 |
| 773 |
| 1 |
| 773 |
| Withdrawal due to health problems unrelated to intervention | General disorders | Non-systematic Assessment |
|
|
Not provided
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| Title | Measurements |
|---|---|
|
| CAMCI - Impaired |
|
| Accuracy |
| 0.5556 |
| 2-Sided |
| 95 |
| 0.4644 |
| 0.6440 |
| Other |
| Sensitivity | 0.9747 | 2-Sided | Other |
| Specificity | 0.3913 | 2-Sided | Other |
| Positive Predictive Value | 0.5625 | 2-Sided | Other |
| Negative Predictive Value | 0.9000 | 2-Sided | Other |
| Sensitivity | 0.1905 | 2-Sided | Other |
| Specificity | 0.9841 | 2-Sided | Other |
| Positive Predictive Value | 0.9231 | 2-Sided | Other |
| Negative Predictive Value | 0.5487 | 2-Sided | Other |
| Sensitivity | 0.6667 | 2-Sided | Other |
| Specificity | 0.8917 | 2-Sided | Other |
| Positive Predictive Value | 0.2353 | 2-Sided | Other |
| Negative Predictive Value | 0.9817 | 2-Sided | Other |
| Quadratic Weighted Kappa | 0.3931 | 2-Sided | 95 | 0.2401 | 0.5461 | Other |
| Title | Measurements |
|---|---|
|
| 12-24 Months |
|