CompletedNot Applicable

Computational Tools for Early Diagnosis of Memory Disorders

Finland126 participantsStarted 2013-12

Plain-language 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.

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT02050464

SponsorUniversity of Eastern Finland

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-04

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