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MCINCT04243642

PJ-011726 IntelliSpace Cognition MCI Study

An observational study of MCI and Cognitive Function 1, Social, run by Philips Clinical & Medical Affairs Global at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
MCI, Cognitive Function 1, Social
What is being tested?
IntelliSpace Cognition
How many people
117 participants
Where
1 siteUnited States
Study dates
30 Jan 2020to 14 Apr 2022
Phase
Observational
Are there results?
None posted in the registry

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 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Aged 50-80
  • Patient is able to give consent
  • MCI or amnestic MCI diagnosis by a clinical specialist, such as a neurologist - diagnosis not older than 12 months prior to inclusions date.
  • 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.

Who cannot join

  • 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],
Show all 32Show fewer
  • 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)
  • 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
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • DENT Neurologic Institute

    Amherst, New York, 14226

Other trials in United States

About this study

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.

Being tested
IntelliSpace Cognition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IntelliSpace CognitionDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Feb-2020 until Dec-2021

  2. 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.

    Measured: Feb-2020 until Dec-2021

  3. 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.

    Measured: Feb-2020 until Dec-2021

  4. 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.

    Measured: Feb-2020 until Dec-2021

Secondary outcomes (3)

  1. Exploratory analysis to find new outcome measures from the raw input data of the digital cognitive tests.

    Measured: Feb-2020 until Dec-2021

  2. Evaluate the performance of ISC scoring algorithms.

    Measured: Feb-2020 until Dec-2021

  3. To explore usability aspects of ISC with MCI patients.

    Measured: Feb-2020 until Dec-2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2020
  2. Study start30 Jan 2020
  3. Primary completion14 Apr 2022
  4. Study completion14 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04243642
Sponsor's protocol ID
ICBE-2-34585
Status last verified
Jul 2022
First submitted
20 Jan 2020
Last updated
18 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of MCI and Cognitive Function 1, Social, run by Philips Clinical & Medical Affairs Global at 1 site 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 8 inclusion and 32 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 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Compare performance of patients with Mild Cognitive Impairment (time frame: Feb-2020 until Dec-2021). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04243642.

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 18 Jul 2022.

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