Clinical trial NCT02050464: Computational Tools for Early Diagnosis of Memory Disorders
Official title: Virtual Physiological Human (VPH) Dementia Research Enabled by IT - Prospective Cohort Kuopio
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Frontotemporal Dementia
Dementia, Vascular
Mild Cognitive Impairment
Keywords: Alzheimer Disease
Frontotemporal Dementia
Dementia, Vascular
Mild Cognitive Impairment
Diagnosis
Risk factors
Biomarkers
AD
FTD
VAD
MCI
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
Collaborators: name: University of Sheffield
name: VTT Technical Research Centre of Finland
name: Klinik Hirslanden, Zurich
name: Sheffield Teaching Hospitals NHS Foundation Trust
First posted: 2014-01-30
Enrollment: 126
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Control subjects with normal cognition

The Alzheimer's disease, Fronto-temporal dementia, Vascular dementia, and Mild Cognitive Impairment will be recruited during their visit in the Neurological clinic at the Kuopio University Hospital.

Brief summary: 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.

Detailed 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".

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity, specificity and accuracy of models for diagnosis of memory disorders
timeFrame: during a single visit, i.e., day 1 and for one study group (MCI) after 18 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Department of Neurology and Brain Research Unit, Institute of Clinical Medicine, University of Eastern Finland
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Tampere
country: Finland
facility: VTT Technical Research Centre of Finland
Study officials:
affiliation: University of Eastern Finland
name: Hilkka Soininen, Professor
role: PRINCIPAL_INVESTIGATOR
References: