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| Name | Class |
|---|---|
| Qserve | INDUSTRY |
| Dent Neurologic Institute | OTHER |
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This study aims to create a reference database of digital cognitive assessment data in combination with neuroimaging data of patients with mild cognitive impairment. The investigators will explore and derive correlations between parameters from routine MRI images and brain volumetric analysis and the digital cognitive data to identify parameters that are relevant to classify MCI patients vs preexisting healthy control data.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IntelliSpace Cognition | Device | Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals (HCP) in assessing the cognition of individuals. It consists of two interfaces connected to the DCDx-module in the cloud. ISC is hosted on the Philips Health Suite Digital Platform (HSDP). The first interface is the patient's interface and is presented via a tablet to collect data on how the patient performs a series of tests. The second interface is the clinician's interface and can be used on any PC or tablet. It allows for assessments to be selected and administered, observations made, data analytics performed and the generation of a report. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare performance of patients with Mild Cognitive Impairment | Create a database of digital cognitive assessment data in combination with neuroimaging data of patients with mild cognitive impairment to: Compare performance of patients with Mild Cognitive Impairment (MCI) to normative data of the healthy US population and characterize a MCI cognitive profile. | Feb-2020 until Dec-2021 |
| Derive correlations between parameters | Create a database of digital cognitive assessment data in combination with neuroimaging data of patients with mild cognitive impairment to: Derive correlations between parameters derived from MRI images (NeuroQuant scores) and the digital cognitive data. | Feb-2020 until Dec-2021 |
| Identify (combinations of) parameters | Create a database of digital cognitive assessment data in combination with neuroimaging data of patients with mild cognitive impairment to: Identify (combinations of) parameters that are relevant to classify MCI patients vs healthy controls. | Feb-2020 until Dec-2021 |
| Explore predictive values | Create a database of digital cognitive assessment data in combination with neuroimaging data of patients with mild cognitive impairment to: Explore predictive value of combination of neuroimaging and digital cognitive outcome parameters to predict MCI to Alzheimer's disease conversion. | Feb-2020 until Dec-2021 |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory analysis to find new outcome measures from the raw input data of the digital cognitive tests. | Feb-2020 until Dec-2021 | |
| Evaluate the performance of ISC scoring algorithms. | Feb-2020 until Dec-2021 |
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Inclusion Criteria:
Exclusion Criteria:
Currently admitted to a hospital, assisted living, nursing home or a psychiatric facility.
Diagnosed with a (neurological) disorder other than MCI or aMCI, i.e.:
Major structural intracranial abnormalities and brain disorders on prior imaging study (in the last 12 months), i.e.:
Any history of having been unconscious related to TBI or "medical condition" > 20 minutes or have had any head-injury resulting in an overnight hospital stay
Any history of a medical event requiring resuscitation in which examinee was non-responsive for > 15 minutes
Currently receiving chemotherapy treatment, or have received chemotherapy treatment in the past 2 months
Any history of ECT or radiation to the CNS
Currently diagnosed with substance abuse or dependence, or have carried any substance abuse or dependence diagnosis in the past year (> 1 year in remission diagnoses are ok)
A current average alcohol consumption of 4 or more units per day. Long term alcohol abusers are excluded as well (e.g., abused substance for more than 10 years)
Currently taking medication that might impact test performance (i.e. anti- convulsants, antipsychotics, benzodiazepines, psychostimulants, opioids, tricyclic Antidepressants, Oxybutynin)
Disruptive behavior or insufficient compliance with testing to ensure a valid assessment
Non-valid health insurance in USA
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The study will include N=125 patients with Mild Cognitive Impairment (MCI).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DENT Neurologic Institute | Amherst | New York | 14226 | United States |
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| To explore usability aspects of ISC with MCI patients. | Feb-2020 until Dec-2021 |