PJ-011726 IntelliSpace Cognition MCI Study

NCT04243642 | Completed FDA Device

• 1 other identifier: ICBE-2-34585
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

MCI; Cognitive Function 1, Social

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (3)

• 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

• To explore usability aspects of ISC with MCI patients.

  Feb-2020 until Dec-2021

Interventions

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.

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include N=125 patients with Mild Cognitive Impairment (MCI).

You may qualify if:

• Aged 50-80
• Patient is able to give consent
• If 3D T1 MRI images are present they cannot be older than 6 months prior to the MCI clinical diagnosis was made.
• Must be proficient in American English.
• If patient has vision impairment or hearing loss, must be corrected to normal.
• Must have use of fingers, hands, and arms to be able to use a pencil to write symbols.
• Must be able to understand test instructions and participate fully in testing.

You may not qualify if:

• 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.:
• Current primary neurodegenerative diseases (e.g., Parkinson's disease, brain tumor, dementia)
• Stroke
• Current TBI
• Current epilepsy \[if # seizures ≤ 2 and not receiving ongoing treatment for seizures, and not currently seeking medical evaluation or attention related to seizures, patient can be accepted\],
• Current encephalitis
• Current language disorder (expressive or mixed receptive/expressive excluded; articulation disorder is ok)
• Current learning disorder
• Current or past psychotic disorder
• Current severe mood disorder (in the case of Major Depressive Disorder in remission or with no current episode, and Dysthymic and Adjustment disorder, examinee can be accepted)
• Current severe anxiety disorder (e.g., PTSD, GAD, OCD) with symptoms significant enough to interfere with optimal test performance (in the case of phobias, examinee can be accepted)
• Current or past Autism Spectrum Disorder or Intellectual Disability
• Primarily nonverbal or uncommunicative
• Current aphasia

Sponsors & Collaborators

• Philips Electronics Nederland B.V. acting through Philips CTO organization: lead
• Qserve: collaborator
• Dent Neurologic Institute: collaborator

Study Sites (1)

DENT Neurologic Institute

Amherst, New York, 14226, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 28, 2020
• Study Start: January 30, 2020
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

US (1)