ONLINE Consent Form

 

Title of the research project

The impact of biological sex, menopausal status and +APOE4 risk for alzheimer's disease on the neural correlates of episodic memory in healthy middle aged adults.

Principal researcher

Maria Natasha Rajah Ph.D.,
Director, Brain Imaging Centre, Douglas Mental Health University Institute,
Associate Professor, Department of Psychiatry, Department of Psychology, McGill University

Funded by the Canadian Institutes of Health Research (CIHR) and Natural Sciences and Engineering Research Council of Canada (NSERC)

Information about our study

The purpose of this research project is to investigate how biological sex, menopausal status, and genetic risk factors for late-onset Alzheimer’s Disease (e.g., Apolipoprotein E [APOE]) impact brain structure, brain activity and memory in healthy middle-aged adults (aged 40-59 yrs. old). In addition, young adults, aged 18-35 yrs., will also be tested as a comparison group and old adults, aged 60-75 yrs, will also be tested as a comparison group for post-menopausal non-transitioning women.

Specifically, we will collect magnetic resonance imaging (MRI) scans as you perform memory tasks. We are inviting you to participate in this research project to help us understand: 1) if men and women show differences in memory and brain function at midlife, compared to young adults, 2) how different genes impact memory and brain function at midlife, and 3) how menopausal status in women with vs. without specific genetic versions (alleles) is associated with memory and brain function.

We hope our results will advance our knowledge of how aging and genetic risk factors for Alzheimer’s disease influence memory and brain function in healthy middle-aged adults. This information may help determine if early interventions are needed to support memory in specific populations of middle-aged adults with a genetic risk factor for late-onset Alzheimer’s disease.

Participation in this study consists of two visits, one behavioural visit to the Douglas Mental Health University Institute Brain Imaging Center and one MRI scanning visit at the Montreal Neurological Institute. There may be approximately a 3-6 month time period between Session 1 and Session 2.

To inform us of your interest in participating in this research project please fill out this online questionnaire.

Online questionnaire

This online questionnaire is given to evaluate your eligibility to participate in our research project. This questionnaire will ask about your medical background and history. The questionnaire contains 85 questions and will take approximately 20 minutes to fill out. You can skip questions you wish not to answer.

If you are eligible to participate in our research project, a member of our team will contact you. He or she will provide further information and explain the steps to follow in becoming one of the participants for our study. Participation to the research project will involve the two following visits.

First visit

During the first visit at the Douglas Institute, a blood test will be done to measure your levels of cholesterol, sugar, hormones (testosterone, progesterone, estradiol, Follicle-Stimulating Hormone [FSH], Luteinizing hormone [LH] and cortisol) and genes that are associated with memory. We will also ask you to complete a series of neuropsychological tests (paper-pencil or computerized tests) where your basic cognitive function, such as memory and attention, will be evaluated.  This should take about 2.5 hours, depending on your speed. In addition, there will be a practice session in a mock magnetic resonance imaging (MRI) scanner in which you will perform a memory test. Because we aim to match males, pre-menopausal females, and post-menopausal females in our MRI experiment based on age, education and memory perform, not everyone who participates in Session 1 will be invited back for Session 2.

Second visit

In the second visit at the Montreal Neurological Institute, you will undergo a functional Magnetic Resonance Imaging scan (or fMRI). An fMRI scan allows us to observe the structure as well as the functioning of your brain. FMRI does not work with radiation and is not associated with any health risks. While you are in the scanner, you will perform several memory tests. The fMRI scan will last between 1.5 and 2 hours.

Are you obligated to participate?

You can end your participation at any time without having to justify yourself. If you decide to quit while filling out the questionnaire, you can simply close the webpage/browser. Even if you complete the questionnaire, you are under no obligation to continue with the next steps in our study. We will contact you to explain to you the subsequent steps to becoming a participant. Then, you can decide if you want to continue the participation process in the study.

Confidentiality

The information in the questionnaires will be treated in a confidential manner. You will be asked personal questions such as your name, sex, age, level of education, a phone number where you can be reached, and an e-mail address if available.

The online medical questionnaire is hosted on the protected servers of the Ministry of Health and the Social Services in Quebec City for three months.

The information collected via the online questionnaire will only be accessible to Dr. Rajah and her research assistant. Collected information will be codified numerically and the recognizable elements (such as your name, phone number, address, e-mail) will be separated from your medical questions answered. The data will be then transferred on Dr Rajah’s laboratory server situated at the Douglas University Institute in Mental Health and be password protected. Only the investigator and her research team will have access to the study data.¬† Data collected on the Ministry of Health and Social Services server will be purged every three months.

Prejudice and potential inconveniences

Some questions may seem peculiar or may seem to have no direct link to your current life situation. Some of the questions regard personal medical history as well as medical history of first degree family members. You may also feel uninterested by some questions, which may seem repetitive to you. However, there are no risks or harm, to our knowledge, related to the completion of this screening questionnaire.

Possible benefits

You will have no direct personal or financial benefit by filling out this questionnaire. This questionnaire will be used to establish your admission as a research participant in our studies.

Who to contact if I have further questions?

For any questions which relate to the project, you may contact Dr Natasha Rajah’s research assistant, Stamatoula Pasvanis at 514-761-6131 extension 2877 or by e-mail at the following address: stamatoula.pasvanis@douglas.mcgill.ca.

If you have any questions concerning your rights as a participant in a research experiment, or if you wish to discuss your participation with an individual not directly involved in this research project, or if you wish to file a complaint, you can contact:

- The Service Quality and Complaints Commission of the Douglas Mental Health University Institute, toll Free Number : 1-844-630-5125 or by email at commissariat.plaintes.comtl@ssss.gouv.qc.ca or the administrator of the Research Ethics Board of the Douglas Mental Health University Institute at 514-761-6131 extension 2708 or by email at cer.reb@douglas.mcgill.ca.

- The Patient Ombudsman of the Montreal Neurological Institute and Hospital at the following phone number: 514-934-1934, extension 22223.

You can print the Online Consent form by selecting the print option in the Menu of your web browser.

 

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