Digital Screening for Dementia
Recruiting in Palo Alto (17 mi)
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Indiana University
Must not be taking: Cholinesterase inhibitors, Memantine
Disqualifiers: Prior ADRD, Bipolar, Schizophrenia, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The specific aim of the pragmatic trial is to evaluate the practical utility and effect of the PDM, the QDRS, and the combined approach (PDM + QDRS) in improving the annual rate of new documented ADRD diagnosis in primary care practices.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Passive Digital Marker (PDM) for dementia?
Research suggests that digital markers, like those used in Passive Digital Marker (PDM) tools, can help detect Alzheimer's disease and related dementias earlier by using data from electronic health records. These digital tools can provide continuous and objective monitoring, which may improve the detection and management of cognitive changes over time.
12345How is the Passive Digital Marker treatment for dementia different from other treatments?
The Passive Digital Marker (PDM) treatment is unique because it uses digital data from electronic health records to detect dementia early, unlike traditional methods that rely on questionnaires and interviews. This approach allows for continuous, objective monitoring of cognitive changes over time, providing a more sensitive and timely assessment of dementia symptoms.
12678Eligibility Criteria
This trial is for caregivers of individuals with Alzheimer's Disease or dementia. It aims to test if using a Passive Digital Marker (PDM) and the Quick Dementia Rating System (QDRS), either alone or combined, can help primary care practices diagnose dementia more frequently within a year.Inclusion Criteria
I am 65 years old or older.
Ability to provide informed consent
I can communicate in English or Spanish.
+2 more
Exclusion Criteria
I have been diagnosed with Alzheimer's or mild cognitive impairment.
I have been prescribed medications for memory problems before.
Has serious mental illness such as bipolar or schizophrenia as determined by ICD-10 code
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Annual Wellness Visit (AWV)
Participants undergo the Annual Wellness Visit, which includes the Passive Digital Marker (PDM) and Quick Dementia Rating Scale (QDRS) assessments for some arms
1 day
1 visit (in-person)
Follow-up
Participants are monitored for new ADRD diagnoses and related services over a 12-month period
12 months
Participant Groups
The study is testing the effectiveness of a Passive Digital Marker tool and the QDRS in detecting Alzheimer's Disease and related dementias. The goal is to see if these methods increase diagnosis rates when used by primary care doctors.
3Treatment groups
Experimental Treatment
Active Control
Group I: Passive Digital Marker (PDM)Experimental Treatment1 Intervention
Passive Digital Marker (PDM): Electronic Health Record Data from those clinics randomized to PDM will be run through the PDM, a machine learning algorithm which can predict ADRD one year and three years prior to its onset.
Group II: Passive Digital Marker (PDM) + Quick Dementia Rating Scale (QDRS)Active Control1 Intervention
Patients in the primary care clinics randomized to PDM+QDRS will have Electronic Health Record Data of their patients run through the PDM, a machine learning algorithm which can predict ADRD one year and three years prior to its onset. In addition, patients from these clinics will have their patients complete the QDRS, a validated patient reported outcome (PRO) tool. This combined approach will assess the value of early detection of ADRD and if the annual well visit can overcome the barriers related to early detection of ADRD.
Group III: Annual Well Visit or any other visit to Primary Care DoctorActive Control1 Intervention
Annual Well Visit or any other visit to Primary Care Doctor: This is the usual care arm. Electronic Health Record Data for patients from the clinics randomized to usual care will be collected for comparison with the other 2 arms. Patients from these primary care clinics must have had a visit to their doctor either as an annual well visit (AWV) or any other type of visit. These clinics will not have to do anything for the study but run their business as usual without altering anything.
Passive Digital Marker is already approved in United States for the following indications:
🇺🇸 Approved in United States as PDM for:
- Alzheimer's disease and related dementias (ADRD) detection
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Miami School of MedicineBoca Raton, FL
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Who Is Running the Clinical Trial?
Indiana UniversityLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Passive digital markers for Alzheimer's disease and other related dementias: A systematic evidence review. [2023]The timely detection of Alzheimer's disease and other related dementias (ADRD) is suboptimal. Digital data already stored in electronic health records (EHR) offer opportunities for enhancing the timely detection of ADRD by facilitating the development of passive digital markers (PDMs). We conducted a systematic evidence review to identify studies that describe the development, performance, and validity of EHR-based PDMs for ADRD.
Current State of Digital Biomarker Technologies for Real-Life, Home-Based Monitoring of Cognitive Function for Mild Cognitive Impairment to Mild Alzheimer Disease and Implications for Clinical Care: Systematic Review. [2020]Among areas that have challenged the progress of dementia care has been the assessment of change in symptoms over time. Digital biomarkers are defined as objective, quantifiable, physiological, and behavioral data that are collected and measured by means of digital devices, such as embedded environmental sensors or wearables. Digital biomarkers provide an alternative assessment approach, as they allow objective, ecologically valid, and long-term follow-up with continuous assessment. Despite the promise of a multitude of sensors and devices that can be applied, there are no agreed-upon standards for digital biomarkers, nor are there comprehensive evidence-based results for which digital biomarkers may be demonstrated to be most effective.
The "portable" CDR: translating the clinical dementia rating interview into a PDA format. [2021]The Clinical Dementia Rating (CDR) is a common rating system used in clinical trials and longitudinal research projects to rate the presence and severity of cognitive problems in Alzheimer disease and related disorders. The interview process requires training and can be time-consuming. Here, we describe the validity, reliability, and discriminative ability of a computer-generated CDR using a personal digital assistant format. This project used clinical data from 138 archival and live evaluations (patient and informant interviews) collected for research purposes at Washington University to develop and test a software-based system for the administration and automatic scoring of the CDR. The system was programmed for use on a hand-held computer via the Palm Operating System. We developed domain-specific algorithms to quantify and translate clinical scoring decisions for the 3 cognitive (Memory, Orientation, Judgment and Problem Solving) and the 3 functional (Community Affairs, Home and Hobbies, Personal Care) domains of the CDR. An acceptable set of algorithms were developed using data from 104 research cases, reflecting a range of impairment levels (CDR 0 to 3) and expert scoring decisions. These algorithms were then tested for accuracy in a validation sample of 34 cases. The computer-generated CDR has excellent internal consistency (Cronbach's alpha ranging from 0.94 to 0.98) and interrater reliability (intraclass correlation coefficient ranging from 0.88 to 0.96). The computer-generated CDR showed excellent discrimination between demented and nondemented cases (Area under the curve=0.95; 95% confidence interval, 0.84-1.1). The computer-generated CDR using a Palm Operating System is easy to use, valid, and reliable. The level of agreement compares favorably to published interrater reliability data for the CDR. Software-based administration and automatic scoring of the CDR is a viable alternative to paper-based methods and may be useful in research and clinical settings, especially where electronic data management and reliability in scoring are critical.
Description of the Method for Evaluating Digital Endpoints in Alzheimer Disease Study: Protocol for an Exploratory, Cross-sectional Study. [2022]More sensitive and less burdensome efficacy end points are urgently needed to improve the effectiveness of clinical drug development for Alzheimer disease (AD). Although conventional end points lack sensitivity, digital technologies hold promise for amplifying the detection of treatment signals and capturing cognitive anomalies at earlier disease stages. Using digital technologies and combining several test modalities allow for the collection of richer information about cognitive and functional status, which is not ascertainable via conventional paper-and-pencil tests.
The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. [2023]The National Institute on Aging and the Alzheimer's Association charged a workgroup with the task of revising the 1984 criteria for Alzheimer's disease (AD) dementia. The workgroup sought to ensure that the revised criteria would be flexible enough to be used by both general healthcare providers without access to neuropsychological testing, advanced imaging, and cerebrospinal fluid measures, and specialized investigators involved in research or in clinical trial studies who would have these tools available. We present criteria for all-cause dementia and for AD dementia. We retained the general framework of probable AD dementia from the 1984 criteria. On the basis of the past 27 years of experience, we made several changes in the clinical criteria for the diagnosis. We also retained the term possible AD dementia, but redefined it in a manner more focused than before. Biomarker evidence was also integrated into the diagnostic formulations for probable and possible AD dementia for use in research settings. The core clinical criteria for AD dementia will continue to be the cornerstone of the diagnosis in clinical practice, but biomarker evidence is expected to enhance the pathophysiological specificity of the diagnosis of AD dementia. Much work lies ahead for validating the biomarker diagnosis of AD dementia.
Digital endpoints in clinical trials of Alzheimer's disease and other neurodegenerative diseases: challenges and opportunities. [2023]Alzheimer's disease (AD) and other neurodegenerative diseases such as Parkinson's disease (PD) and Huntington's disease (HD) are associated with progressive cognitive, motor, affective and consequently functional decline considerably affecting Activities of Daily Living (ADL) and quality of life. Standard assessments, such as questionnaires and interviews, cognitive testing, and mobility assessments, lack sensitivity, especially in early stages of neurodegenerative diseases and in the disease progression, and have therefore a limited utility as outcome measurements in clinical trials. Major advances in the last decade in digital technologies have opened a window of opportunity to introduce digital endpoints into clinical trials that can reform the assessment and tracking of neurodegenerative symptoms. The Innovative Health Initiative (IMI)-funded projects RADAR-AD (Remote assessment of disease and relapse-Alzheimer's disease), IDEA-FAST (Identifying digital endpoints to assess fatigue, sleep and ADL in neurodegenerative disorders and immune-mediated inflammatory diseases) and Mobilise-D (Connecting digital mobility assessment to clinical outcomes for regulatory and clinical endorsement) aim to identify digital endpoints relevant for neurodegenerative diseases that provide reliable, objective, and sensitive evaluation of disability and health-related quality of life. In this article, we will draw from the findings and experiences of the different IMI projects in discussing (1) the value of remote technologies to assess neurodegenerative diseases; (2) feasibility, acceptability and usability of digital assessments; (3) challenges related to the use of digital tools; (4) public involvement and the implementation of patient advisory boards; (5) regulatory learnings; and (6) the significance of inter-project exchange and data- and algorithm-sharing.
Validation of a new mass screening tool for cognitive impairment: Cognitive Assessment for Dementia, iPad version. [2022]We have developed a new screening test for dementia that runs on an iPad and can be used for mass screening, known as the Cognitive Assessment for Dementia, iPad version (CADi). The CADi consists of items involving immediate recognition memory for three words, semantic memory, categorization of six objects, subtraction, backward repetition of digits, cube rotation, pyramid rotation, trail making A, trail making B, and delayed recognition memory for three words. The present study examined the reliability and validity of the CADi.
Evaluation of the Electronic Clinical Dementia Rating for Dementia Screening. [2023]The Clinical Dementia Rating (CDR) is a well-validated instrument widely used to detect and stage dementia due to Alzheimer disease. The digital Electronic Clinical Dementia Rating (eCDR) can be remotely self-administered and automatically scored, with potential to facilitate efficient dementia screening and staging.