Cognitive DysfunctionNCT03512301
CAMCI: Advancing the Use of Computerized Screening in Healthcare
A study testing CAMCI, MoCA and Clinical Adjudication in people with Cognitive Dysfunction and Cognitive Impairment, run by Psychology Software Tools, Inc. at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction, Cognitive Impairment, Cognitive Decline
- What is being tested?
- CAMCI, MoCA and Clinical Adjudication
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 773 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Aug 2019to 31 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Adequate visual and auditory acuity to allow neuropsychological testing
- Able to read, write and understand study and test requirements
- Within the age range of 60+
Who cannot join
- Significant neurologic disease, such as multi-infarct dementia, Parkinson's disease, epilepsy, stroke, multiple sclerosis or head trauma
- History of major depression or other major psychiatric disorder, such as, schizophrenia and bipolar disorder
- History of consuming 5 or more alcoholic drinks per day on a regular basis
- Montreal Cognitive Assessment (MoCA) score <10
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Virginia
Charlottesville, Virginia, 22904
Baylor College of Medicine
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
Psychology Software Tools
Sharpsburg, Pennsylvania, 15215
About this study
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.
Read the detailed description
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.
- Being tested
- CAMCI, MoCA, Clinical Adjudication
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAMCIDevice
Also called Computer Assessment of Memory and Cognitive Impairment
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.
MoCADiagnostic test
Also called Montreal Cognitive Assessment
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 AdjudicationDiagnostic test
Also called Neuropsychological Tests
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: CAMCI; Diagnostic Test: MoCA; Diagnostic Test: Clinical Adjudication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start8 Aug 2019
- Primary completion31 May 2023
- Study completion31 May 2023
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.
- Other trials for Cognitive DysfunctionStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 773 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psychology Software Tools, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Amy Eschman, Psychology Software Tools, Inc.
- Investigators
- Anthony Zuccolotto, Study director, Psychology Software Tools
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512301
- Sponsor's protocol ID
- 13
- Other IDs
- 2SB1AG037357-04A1
- Status last verified
- Jun 2025
- First submitted
- 17 Apr 2018
- Last updated
- 26 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAMCI: Advancing the Use of Computerized Screening in Healthcare
- ClinicalTrials.gov ID
- NCT03512301
- Acronym / sponsor ID
- 13
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 773 participants (actual)
- Lead sponsor
- Psychology Software Tools, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 30 Apr 2018 (actual)
- Results
- Posted 26 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAMCI Validation | Experimental | Device: CAMCI, Diagnostic Test: MoCA, Diagnostic Test: Clinical AdjudicationCompletion of computerized tasks (Computer Assessment of Memory and Cognitive Impairment) and traditional neuropsychological tests administered via paper-pencil method by a trained administrator |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Adequate visual and auditory acuity to allow neuropsychological testing
- Able to read, write and understand study and test requirements
- Within the age range of 60+
Key exclusion criteria (4 listed)
- Significant neurologic disease, such as multi-infarct dementia, Parkinson's disease, epilepsy, stroke, multiple sclerosis or head trauma
- History of major depression or other major psychiatric disorder, such as, schizophrenia and bipolar disorder
- History of consuming 5 or more alcoholic drinks per day on a regular basis
- Montreal Cognitive Assessment (MoCA) score <10
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAMCIAlso: Computer Assessment of Memory and Cognitive ImpairmentCAMCI 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. | Device | CAMCI Validation |
| MoCAAlso: Montreal Cognitive AssessmentThe 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 | Diagnostic test | CAMCI Validation |
| Clinical AdjudicationAlso: Neuropsychological TestsCognitive 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. | Diagnostic test | CAMCI Validation |
Primary outcome
Agreement Analysis (Agreement to Reference Standard) - Test Group
Time frame: baseline
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.
Agreement Analysis (Agreement to Non-Reference Standard) - Test Group
Time frame: baseline
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Zuccolotto study director
Psychology Software Tools
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAMCI, MoCA and Clinical Adjudication in people with Cognitive Dysfunction and Cognitive Impairment, run by Psychology Software Tools, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Analysis (Agreement to Reference Standard) - Test Group (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.