Trial record 20 of 2263 for:    "Dementia"

Computational Tools for Early Diagnosis of Memory Disorders (ProsKuopio)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Sheffield
VTT Technical Research Centre of Finland
Klinik Hirslanden, Zurich
Sheffield Teaching Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Hilkka Soininen, University of Eastern Finland
ClinicalTrials.gov Identifier:
NCT02050464
First received: January 15, 2014
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition
Alzheimer Disease
Frontotemporal Dementia
Dementia, Vascular
Mild Cognitive Impairment

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: Virtual Physiological Human (VPH) Dementia Research Enabled by IT - Prospective Cohort Kuopio

Resource links provided by NLM:


Further study details as provided by University of Eastern Finland:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

whole blood, serum, plasma, white cells


Estimated Enrollment: 120
Study Start Date: December 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy controls
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

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

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02050464

Locations
Finland
Department of Neurology and Brain Research Unit, Institute of Clinical Medicine, University of Eastern Finland
Kuopio, Finland, FI-70211
Kuopio University Hospital
Kuopio, Finland, FI-70211
VTT Technical Research Centre of Finland
Tampere, Finland
Sponsors and Collaborators
University of Eastern Finland
University of Sheffield
VTT Technical Research Centre of Finland
Klinik Hirslanden, Zurich
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Hilkka Soininen, Professor University of Eastern Finland
  More Information

Additional Information:
No publications provided

Responsible Party: Hilkka Soininen, Hilkka Soininen, Professor, MD, PhD, University of Eastern Finland
ClinicalTrials.gov Identifier: NCT02050464     History of Changes
Other Study ID Numbers: 207094
Study First Received: January 15, 2014
Last Updated: January 28, 2014
Health Authority: Finland: Ethics Committee

Keywords provided by University of Eastern Finland:
Frontotemporal Dementia
Dementia, Vascular
Alzheimer Disease
Mild Cognitive Impairment
Diagnosis
Risk factors
Biomarkers
AD
FTD
VAD
MCI

Additional relevant MeSH terms:
Dementia
Dementia, Vascular
Frontotemporal Dementia
Delirium, Dementia, Amnestic, Cognitive Disorders
Alzheimer Disease
Memory Disorders
Aphasia, Primary Progressive
Pick Disease of the Brain
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases

ClinicalTrials.gov processed this record on April 14, 2014