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Computational Tools for Early Diagnosis of Memory Disorders (ProsKuopio)

U

University of Eastern Finland

Status

Completed

Conditions

Alzheimer Disease
Frontotemporal Dementia
Mild Cognitive Impairment
Dementia, Vascular

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

The Virtual Physiological Human: DementiA Research Enabled by IT (VPH-DARE@IT) is a four-year IT-project funded through the European Union (EU). The project consortium involves a total of 21 universities and industrial partners from 10 European countries. The project delivers the first patient-specific predictive models for early differential diagnosis of dementia and their evolution. An integrated clinical decision support platform will be validated / tested by access to a dozen databases of international cross-sectional and longitudinal studies. As a part of the VPH-DARE@IT project, a new prospective cohort will be collected in Kuopio. This prospective cohort will be used to test further the modeling approaches and tools developed by using the retrospective databases.

Full description

The Virtual Physiological Human: DementiA Research Enabled by IT (VPH-DARE@IT) is a four-year IT-project funded through the European Union (EU). The project will develop multiscale models of the ageing brain in order to account simultaneously for the patient-specific biochemical, metabolic and biomechanical brain substrate, as well as for genetic, clinical, demographic and lifestyle determinants. An integrated clinical decision support platform will be validated and tested by access to a dozen databases of international cross-sectional and longitudinal studies.

Modeling approaches developed by using the retrospective databases will be tested using a new prospective cohort that will be collected in Kuopio as a part of the VPH-DARE@IT project. The study population at university of Eastern Finland (UEF) will be a total of 120 subjects: 20 healthy controls (HC), 20 mild to moderate Alzheimer's disease (AD) patients, 20 vascular dementia (VAD) patients, 20 fronto-temporal dementia (FTD) patients and 40 subjects with mild cognitive impairment (MCI). This study is referred as VPH-DARE@IT Prospective study in Kuopio or "ProsKuopio".

Enrollment

126 patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Inclusion criteria for subjects with dementia (AD, VAD, FTD) - The inclusion criteria will be based on international research criteria:

  • Diagnosis of probable AD according to National Institute of Neurological and Communicative Disorders and Stroke Alzheimer's (NINCDS-ADRDA) criteria (McKhann et al.1984) and diagnosis of prodromal AD according to Dubois et al., 2007 criteria
  • Diagnosis of FTD according to the clinical diagnostic criteria of Neary et al., 1998
  • Diagnosis of VAD according to diagnostic criteria for research studies by the NINDSAIREN International Workshop (Román et al., 1993)

Inclusion criteria for subjects with MCI

  • Referral because of cognitive impairments
  • Diagnosis criteria for amnestic and nonamnestic MCI (Petersen, 2004, Petersen and Morris, 2005)

Inclusion criteria for control subjects

  • Mini-mental state examination (MMSE) score above or equal to 27
  • Overall score on the Clinical Dementia Rating (CDR) scale of 0

Exclusion criteria

Exclusion criteria for all subjects

  • Other causes of dementia
  • Obvious brain, systemic or psychiatric disorders that could potentially affect cognitive functions such as stroke, severe depression, or endocrine disorders

Exclusion criteria for control subjects and subjects with MCI

  • Diagnosis of dementia according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) criteria at baseline

Trial design

126 participants in 5 patient groups

Healthy controls
Description:
Healthy controls
Alzheimer's disease
Description:
Patients with mild Alzheimer's disease
Vascular dementia
Description:
Patients with vascular dementia
Fronto-temporal dementia
Description:
Patients with fronto-temporal dementia
Mild cognitive impairment
Description:
Patients with mild cognitive impairment

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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