Computational Tools for Early Diagnosis of Memory Disorders

NCT02050464 | Completed

• 1 other identifier: 207094
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity, specificity and accuracy of models for diagnosis of memory disorders

  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

Study Arms (5)

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

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)
• Referral because of cognitive impairments
• Diagnosis criteria for amnestic and nonamnestic MCI (Petersen, 2004, Petersen and Morris, 2005)
• Mini-mental state examination (MMSE) score above or equal to 27
• Overall score on the Clinical Dementia Rating (CDR) scale of 0

You may not qualify if:

• Other causes of dementia
• Obvious brain, systemic or psychiatric disorders that could potentially affect cognitive functions such as stroke, severe depression, or endocrine disorders
• \- Diagnosis of dementia according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) criteria at baseline

Sponsors & Collaborators

• University of Eastern Finland: lead
• University of Sheffield: collaborator
• VTT Technical Research Centre of Finland: collaborator
• Klinik Hirslanden, Zurich: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator

Study Sites (3)

Department of Neurology and Brain Research Unit, Institute of Clinical Medicine, University of Eastern Finland

Kuopio, FI-70211, Finland

Location

Kuopio University Hospital

Kuopio, FI-70211, Finland

Location

VTT Technical Research Centre of Finland

Tampere, Finland

Location

Related Links

• Click here for more information about VPH-DARE@IT project

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plasma, white cells

MeSH Terms

Conditions

Alzheimer Disease; Frontotemporal Dementia; Dementia, Vascular; Cognitive Dysfunction; Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hilkka Soininen, Professor

  University of Eastern Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hilkka Soininen, Professor, MD, PhD

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 30, 2014
• Study Start: December 1, 2013
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

FI (3)