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It is essential that you understand all the information contained in this consent form. Do not hesitate to ask questions if there is a word or a phrase that you do not understand or if any information is unclear. 1. Title of the study "Cognitive training and testing as a new approach for the prevention of the dementias" You are invited to participate in this research project. The objective of this study is to investigate variables and factors that might play a role in the prevention of Dementia. Dementia is situation where your cognitive abilities (remembering names and locations, solving problems, managing tasks) is greatly diminished. Of the different forms of dementia, Alzheimer's disease is the best known one, since it affects the most number of people. It is estimated that one in four persons over the age of 85 suffers from this form of Dementia. With your participation in this study, we hope to better understand what factors might contribute to the prevention of this disease. You are free to participate to this study and you may withdraw your participation at any time. 2. Researchers responsible for the project The principal investigator is Dr. Jens Pruessner from the Department of Psychiatry, McGill University. The co-investigators are Dr. Natasha Rajah, Department of Psychiatry, McGill University, and Dr. Gauthier, McGill Centre for Studies in Aging. 3. Protocol Number This protocol was assigned the number 09/38 by the Douglas Hospital Research Ethics Board 4. Sponsor or funding organization This study is funded by the McGill Centre for Studies in Aging. 5. Nature of the research This study examines the effects that cognitive training has on the development of your cognitive abilities over time (solving problems, learning and remembering, etc.) One of the approaches to help people with Alzheimer disease is to understand what factors help prevent it. Previous so-called prevention studies that have been performed in the area of Alzheimer's disease have established that cognitive training, defined as the recurrent training of your cognitive abilities, might prevent, or delay the onset of Dementia. In the current study, we want to investigate the effect of training on your cognitive abilities, over time. We will thus invite you to play a number of games that have been discussed as allowing you to improve your cognitive abilities, and allow you to assess your cognitive status repeatedly over time using standardized tests that have been adapted for computerized use. In the future, we might also invite you to take part in subsequent phases of this project, including laboratory assessments, Magnetic Resonance Imaging tests, and blood sampling. Your participation in any subsequent testing sessions is entirely voluntary and you don't need to participate in subsequent testing sessions in order to participate in the first phase. Cognitive training has been found effective in the prevention of dementia, however the exact parameters (kind of task, intensity of training, duration of training, magnitude of effect) are unknown. Thus, we are hoping that this study will determine more firmly the benefits of cognitive training in the prevention of dementia in the long run, and that we can identify the key variables effective in prevention. It also has to be kept in mind that while cognitive training is likely one important factor, there are other factors (blood pressure, dieting, exercise, lifestyle, blood glucose levels) that are as important, or perhaps more important than cognitive training in the prevention of dementia. Thus, these additional factors should be kept in mind and equally monitored when participating in this project. 6. Description of the research This prevention program, called 'PONDER' (Prevention of Neurodegenerative Disease in Elderly at Risk) is accessible through a McGill website and uses a McGill domain name (URL: http://ponder.mcgill.ca/). In order to take part, you will have to register at this website. You will have to provide your name, age, gender, and a valid email address as the minimum requirements to take part. Once you have created a Password (your email address will serve as your username), you will then have access to the website's secure content. The cognitive games and quizzes will then be accessible on a secure section. Overall, the homepage will contain the following sections: personal information, mailbox, play a game / take a quiz, view results, and a progress tracker. In the personal information section you can input additional demographics (years of education, socioeconomic status, exercise information, dietary and lifestyle information). The mailbox will allow communication between the investigators of the prevention program and you, in case you would like to ask direct questions to the investigator. It will also serve as a place to provide newsletter, and updates to the site and the program. The play a game / take a quiz section will provide a list of cognitive tasks that you can chose from, but will also suggest games and quizzes that you might not have tried or completed yet. You will be able to log on as often as you want to play the games and take the quizzes. The only requirement to be eligible for later study phases is that you complete a standardized assessment once every six months. Finally, the view results section will allow you to see the individual results of your games and quizzes, where the progress tracker will provide the longitudinal results with performance graphs. 7. Participation in this research project If you wish to withdraw from this research project, you may do so at any time. Upon request, we will delete your account, and all of your personal data, from the website, and our records. Your initial decision to participate in the research is not binding. It is important to you can withdraw from this study at any time without negative consequences. Your entitlements to care, education and other services will not be prejudiced by the decision on whether to participate or to continue participation once the research has begun. The researchers may also decide, at any time, to terminate your participation, in part or in full, if there is a reason to do so. 8. Risks associated with this research project There are no known harms associated with your participation in this research project. 9. Risks associated with pregnancy There are no known harms associated with participation of pregnant women in this research project. 10. Disadvantages for the research subjects There are no known disadvantages deriving from participating in this research project. 11. Benefits for the research subjects Cognitive training has been found effective in the prevention of dementia, however the exact parameters (kind of task, intensity of training, duration of training, magnitude of effect) are unknown. Thus, it is unknown whether there will be a direct benefit from participating in this project. 12. Other possible treatments There are no known other possible treatments for this type of research question at this time. 13. Voluntary participation and right to withdraw at any time Your participation in this research project is voluntary and you are free to withdraw from this study at any time, without giving any reasons. At the same time, the researcher has the right to terminate this study at any time for any reason, without providing any reason. 14. Confidentiality All the information that you will provide will remain confidential. Answers to questions from interviews will not be disclosed to other users or any other professional. In order to ensure this confidentiality, instead of your name we will be using numbers to identify the documents which will be used to collect data. This way, all information will remain confidential. We will not be using any information which could allow the identification of one person or another in our database. The list of all participants will be kept in a secure place and will only be used by the members of the research team. The study data gathered in the first phase could be used in subsequent phases of this research. We will keep your coding information in a secure place to which only the principal investigator will have access. Should we notice a significant deterioration in your performance, we would use this information to identify the subject and contact him / her, to alert him of the decrease in performance and suggest follow-up measures (contact your local Medical Practitionier, or your nearest memory clinic, for example. In case that the subject is from the local area, we might invite him or her to the McGill Centre for Studies in Aging for clinical follow-up. 15. Possibility for commercialisation The possibility for commercialization of this research project is currently unknown. 16. Funding for the research project The McGill Centre for Studies in Aging provides the funding for this research project. 17. Indemnation in case of prejudice and rights of the research subject 18. Compensation You will receive no compensation for your participation in this study. In return, we will never ask any fee from you to access our website, our cognitive assessments, and our training instruments. 19. Identification of responsible researchers To obtain more information about this study, you can contact : Dr. Jens Pruessner Douglas Institute, FBC 3 6875 Boulevard LaSalle Verdun, QC H4H 1R3 Quebec, Canada Tel. +1 (514) 761 6131 x4399 Fax +1 (514) 888 4050 20. Adherance to ethical aspects For any question related to your rights as a research participant or for any ethical problem concerning the conditions in which this research project is being conducted, you may contact the Ombudsman of the Douglas Mental Health University Institute, 6875 Lasalle blvd., Montreal (Quebec) H4H 1R3, telephone : (514) 761-6131 local 3287, e-mail : Ombudsman@douglas.mcgill.ca CONSENT The objectives and the procedures of this research project to which I am about to agree to participate, have been explained to me clearly in this document. I have read this consent form for participants and I understand the benefits and the risks that are involved in my participation to this project. I have had the opportunity and the time to ask questions, which have been answered by the research team to my satisfaction. I understand that my participation is entirely voluntary and that I may withdraw at any time without any consequence and if I do so, I will not suffer any negative consequences and it will not compromise the care and services which I will receive in the future. By clicking on 'I agree and I wish to continue with the study', I agree to participate in this research project.
I agree and I wish to continue with the study
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Click here if you are interested in participating in future studies (not necessarily related to PONDER)
Upon registering, an email will be sent to you confirming your registration (It might end up in your junk mail folder).
* Please note that all of your information will be kept confidential and will not be distributed to any other parties.