Alzheimer DiseaseProsKuopioNCT02050464
Computational Tools for Early Diagnosis of Memory Disorders
An observational study of Alzheimer Disease and Frontotemporal Dementia, run by University of Eastern Finland at 3 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Disease, Frontotemporal Dementia, Dementia, Vascular
- How many people
- 126 participants
- Where
- 3 sitesFinland
- Study dates
- Dec 2013to Apr 2017
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Finland3 sites
Department of Neurology and Brain Research Unit, Institute of Clinical Medicine, University of Eastern Finland
Kuopio, FI-70211
Kuopio University Hospital
Kuopio, FI-70211
VTT Technical Research Centre of Finland
Tampere
About this study
Official title: 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.
Read the 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".
- Keywords
- Alzheimer Disease, Frontotemporal Dementia, Dementia, Vascular, Mild Cognitive Impairment, Diagnosis, Risk factors, Biomarkers, AD, FTD, VAD, MCI
- Medical subject headings
- Alzheimer Disease, Frontotemporal Dementia, Dementia, Vascular, Cognitive Dysfunction, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during a single visit, i.e., day 1 and for one study group (MCI) after 18 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield, VTT Technical Research Centre of Finland, Klinik Hirslanden, Zurich, Sheffield Teaching Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Hilkka Soininen, University of Eastern Finland
- Investigators
- Hilkka Soininen, Professor, Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050464
- Sponsor's protocol ID
- 207094
- Acronym
- ProsKuopio
- Status last verified
- May 2017
- First submitted
- 15 Jan 2014
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Physiological Human (VPH) Dementia Research Enabled by IT - Prospective Cohort Kuopio
- ClinicalTrials.gov ID
- NCT02050464
- Acronym / sponsor ID
- ProsKuopio / 207094
- Keywords
- Alzheimer Disease, Frontotemporal Dementia, Dementia, Vascular, Mild Cognitive Impairment, Diagnosis, Risk factors, Biomarkers, AD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Collaborators
- University of Sheffield, VTT Technical Research Centre of Finland, Klinik Hirslanden, Zurich, Sheffield Teaching Hospitals NHS Foundation Trust
- Study start
- Dec 2013
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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)
- Referral because of cognitive impairments
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilkka Soininen, Professor principal investigator
University of Eastern Finland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Frontotemporal Dementia, run by University of Eastern Finland at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.