Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

PJ-011726 IntelliSpace Cognition MCI Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243642
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
Qserve
Information provided by (Responsible Party):
Philips Electronics Nederland B.V. acting through Philips CTO organization

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.

Condition or disease Intervention/treatment
MCI Cognitive Function 1, Social Device: IntelliSpace Cognition

Layout table for study information
Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PJ-011726 IntelliSpace Cognition MCI Study
Actual Study Start Date : January 30, 2020
Estimated Primary Completion Date : December 19, 2021
Estimated Study Completion Date : December 19, 2021

Intervention Details:
  • Device: IntelliSpace Cognition
    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.


Primary Outcome Measures :
  1. Compare performance of patients with Mild Cognitive Impairment [ Time Frame: Feb-2020 until Dec-2021 ]
    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.

  2. Derive correlations between parameters [ Time Frame: Feb-2020 until Dec-2021 ]
    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.

  3. Identify (combinations of) parameters [ Time Frame: Feb-2020 until Dec-2021 ]
    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.

  4. Explore predictive values [ Time Frame: Feb-2020 until Dec-2021 ]
    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.


Secondary Outcome Measures :
  1. Exploratory analysis to find new outcome measures from the raw input data of the digital cognitive tests. [ Time Frame: Feb-2020 until Dec-2021 ]
  2. Evaluate the performance of ISC scoring algorithms. [ Time Frame: Feb-2020 until Dec-2021 ]
  3. To explore usability aspects of ISC with MCI patients. [ Time Frame: Feb-2020 until Dec-2021 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will include N=125 patients with Mild Cognitive Impairment (MCI).
Criteria

Inclusion Criteria:

  1. Aged 50-80
  2. Patient is able to give consent
  3. MCI or amnestic MCI diagnosis by a clinical specialist, such as a neurologist - diagnosis not older than 12 months prior to inclusions date.
  4. If 3D T1 MRI images are present they cannot be older than 6 months prior to the MCI clinical diagnosis was made.
  5. Must be proficient in American English.
  6. If patient has vision impairment or hearing loss, must be corrected to normal.
  7. Must have use of fingers, hands, and arms to be able to use a pencil to write symbols.
  8. Must be able to understand test instructions and participate fully in testing.

Exclusion Criteria:

  1. Currently admitted to a hospital, assisted living, nursing home or a psychiatric facility.
  2. 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
    • LUPUS
    • Multiple Sclerosis
    • Sleep apnea (moderate or severe, Apnea-Hypopnea Index <15 is acceptable)
  3. Major structural intracranial abnormalities and brain disorders on prior imaging study (in the last 12 months), i.e.:

    • Major developmental disorders (e.g., polymicrogyria, schizencephaly)
    • Intracranial tumors: intraaxial (brain tumors); extraaxial (tumors of bone and meninges) insofar they exert mass effect on the brain with edema or gliosis
    • Chronic brain injury and acquired focal or diffuse loss of normal parenchyma regardless of the etiology (e.g. prior stroke,brain surgery, trauma, atrophy due to neurodegenerative disease such as frontotemporal degeneration; or other causes), with the exception of age related changes (e.g. mild-moderate cerebral volume loss) on either side and prior surgery that involved only the skull but not the brain
    • Vascular encephalopathy, defined as Fazekas grade 2 or lower
  4. 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
  5. Any history of a medical event requiring resuscitation in which examinee was non-responsive for > 15 minutes
  6. Currently receiving chemotherapy treatment, or have received chemotherapy treatment in the past 2 months
  7. Any history of ECT or radiation to the CNS
  8. 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)
  9. 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)
  10. Currently taking medication that might impact test performance (i.e. anti- convulsants, antipsychotics, benzodiazepines, psychostimulants, opioids, tricyclic Antidepressants, Oxybutynin)
  11. Disruptive behavior or insufficient compliance with testing to ensure a valid assessment
  12. Non-valid health insurance in USA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243642


Contacts
Layout table for location contacts
Contact: Mandy Spaltman +31 (0) 40 279 1111 mandy.spaltman@philips.com
Contact: Daisy van Minde

Locations
Layout table for location information
United States, New York
DENT Neurologic Institute Recruiting
Amherst, New York, United States, 14226
Contact: Nandor Pinter, MD         
Sponsors and Collaborators
Philips Electronics Nederland B.V. acting through Philips CTO organization
Qserve
Layout table for additonal information
Responsible Party: Philips Electronics Nederland B.V. acting through Philips CTO organization
ClinicalTrials.gov Identifier: NCT04243642    
Other Study ID Numbers: ICBE-2-34585
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No