PJ-011726 IntelliSpace Cognition MCI Study

  • STATUS
    Recruiting
  • participants needed
    125
  • sponsor
    Philips Electronics Nederland B.V. acting through Philips CTO organization
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Updated on 19 February 2024
See if I qualify
cognitive impairment
cognitive assessment
mild cognitive impairment

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.

Details
Condition MCI, Cognitive Function 1, Social
Age 50-80 years
Treatment IntelliSpace Cognition
Clinical Study IdentifierNCT04243642
SponsorPhilips Electronics Nederland B.V. acting through Philips CTO organization
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

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
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)
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. anticonvulsants, 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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