We are looking for people with mild cognitive impairment (MCI) who are willing to take part in a large European study
AI-Mind study takes place in Norway, Finland, Italy and Spain, and it aims to involve 1’000 participants.
The study will help to develop and validate artificial intelligence (AI) based tools to predict who is likely to develop dementia.
Are you interested in including your patients in the study? Register your interest at the regional study site and we will contact you.
Study background
More than 10 million European show signs of mild cognitive impairment (MCI). The evolution of MCI differs from person to person, but many of those affected may progress to dementia. We know already that lifestyle changes and medical interventions can stop or slow down the development of dementia if the risk is identified at an early stage.
In the EU, the diagnosis of MCI is still largely based on classical neuropsychological testing (NTP). However, NTP is unable to discriminate within the MCI population between those who will progress to dementia and those who will not.
AI-Mind aims to establish an early population-based, cost-efficient screening method for synaptic pathology by empowering electroencephalogram (EEG) with a more sophisticated data interpretation and analysis.
Thanks to artificial intelligence (AI)-based tools, AI-Mind will offer health professionals the opportunity to apply preventive interventions for modifiable risk factors and initiate treatment early in the course of the disease.
Study facts
- Part of international 5-years project
- Enrolled in 4 countries in 5 hospitals
- 2 years duration
- 250 participants per country, 1000 participants in total
- Secured data management
- Men and women aged between 60 and 80 years
- MMSE>25 points, MOCA> 17 points, suggestive of MCI
- IADL/ADL / ADCS-ADL
- Petersen/Winblad criteria, 1.5 SD in one or more domains (will be evaluated by the AI-Mind team)
- CDR≤0.5
- Subjective and objective worry of cognitive impairment
- History of a major stroke, major neuropsychiatric disorder, severe head trauma, alcohol abuse, malignancy within 5 years
- Recent initialization of psychotropic drugs including AChEI and Memantine
Want to include your patients in the study?
Steps to follow
Register your interest at the local study site
We will contact you
What is your role?
Screen patient for inclusion and exclusion criteria
Easy MCI test score using MoCa, MMSE
If eligible?
Enroll the patient with the local recruitment team or give material for the patient to learn about the study.
Follow-up your patient in the same manner as you would do when you suspect MCI.
Include your patients at the regional study site, contact:
Dr. Ira Haraldsen
Prof. Paolo Rossini
Prof. Camillo Mara
Finland, Helsinki University Hospital
Prof. Hanna Renvall
Spain, Complutense University of Madrid
Prof. Fernando Maestú
FAQ
The study will last around 2 years, involving 4 appointments every 8 months.
The final decision for inclusion will be made by authorized members/personnel of our clinical study team.
No, you may refer as many patients as you want. The clinical study team will make the decision when the desired number of participants.
This may vary from country to country. But it would not be longer than one month.
The follow-up will be different in each national clinical site.
In Norway, each participant will receive a personalised report based on the findings, with recommendations for potential further treatment. This will be accomplished in cooperation with the participant’s family doctor.
In Italy, patient will be informed on the results of the single investigation but since his/hers data will be processed automatically with use of an AI, we will not be able to assess the risk during the study, as tools will be still developed and validated. However, patient will be informed of any clinical risk of progression that could be appreciated by the referent neurologist.
This may vary from country to country. In Norway, Finland and Italy, each participant will get their own personalised report. This report may be provided after single investigation or after the end of the study depending on the country. It will include a summary of results and a recommendation for further follow-ups/treatment.
Yes, patients with MCI diagnosis should follow the ordinary treatment and instrumental investigation procedures in parallel to the AI-Mind study.
Depending on which test you perform (MoCa or MMSE), we anticipate that the combined investigation from your side would take approximately 15 – 20 minutes.
You will be able to know the descriptive results of the single examinations but not the final report that will be the general objective of the study.
This will vary from country to country. However, the main benefit is that your patients will be carefully followed-up in the next four years with both conventional and experimental procedures to intercept the onset of dementia.
Moreover, in Norway doctors will be able to convert time spent on the AI-Mind study into credits.
In Italy, you will not receive any fees for your screening but you can simply refer your patients to the centre for a prescreening if you have some suspect of MCI.
Please contact regional study team for more information.
Due to the Covid-19 pandemic, our clinical study will take the necessary actions to secure the safety of you as participant and our clinical staff. This study will follow the European guidelines for trial management during the Covid-19 pandemic. In addition, we will follow all up-to-date national and institutional guidelines and regulations. For more information, please see the information letter provided by your national AI-Mind unit.
This research project has been approved by the National Committees for Medical and Health Research Ethics. If you have any concerns or complaints about the conduct of this research project, you should contact the Data Protection Officer Åsmund Marthinsen, Oslo University Hospital, Norway by e-mail at toamar@ous -hf.no, 23015022, Oslo University Hospital. You have the right to submit a complaint about the processing of your personal health information to Datatilsynet (Datatilsynet, [email protected], 22 39 69 00, Postboks 458 Sentrum 0105 Oslo).