Computational Tools for Early Diagnosis of Memory Disorders (ProsKuopio)

May 3, 2017 updated by: Hilkka Soininen, University of Eastern Finland

Virtual Physiological Human (VPH) Dementia Research Enabled by IT - Prospective Cohort Kuopio

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.

Study Overview

Status

Completed

Conditions

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".

Study Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, FI-70211
        • Department of Neurology and Brain Research Unit, Institute of Clinical Medicine, University of Eastern Finland
      • Kuopio, Finland, FI-70211
        • Kuopio University Hospital
      • Tampere, Finland
        • VTT Technical Research Centre of Finland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy controls
Alzheimer's disease
Patients with mild Alzheimer's disease
Vascular dementia
Patients with vascular dementia
Fronto-temporal dementia
Patients with fronto-temporal dementia
Mild cognitive impairment
Patients with mild cognitive impairment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity, specificity and accuracy of models for diagnosis of memory disorders
Time Frame: during a single visit, i.e., day 1 and for one study group (MCI) after 18 month follow-up
The models developed the VPH-DARE project will be tested in this prospective cohort. Sensitivity, specificity and accuracy of the model will be tested in differential diagnosis between the study groups as well as the accuracy of prediction cognitive decline as measured by neuropsychological test battery in the MCI group.
during a single visit, i.e., day 1 and for one study group (MCI) after 18 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Eastern Finland

Collaborators

University of Sheffield
Sheffield Teaching Hospitals NHS Foundation Trust
VTT Technical Research Centre of Finland
Klinik Hirslanden, Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

April 1, 2017

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

January 15, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (ESTIMATE)

January 30, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 207094

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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