Patient Journey

 

What is it like to take part in research?
Deciding to take part in research can feel daunting and scary. For many of us, this is an entirely new experience that is sometimes resorted to when traditional lines of treatment have not worked. For others, it might be because a clinical trial can provide treatment or medication which is potentially more advanced, or there are no suitable options on the market. Some clinical trials assess medications which are disease-altering rather than trying to manage symptoms or delay progression.

Registering your interest
The first step of every study which we run requires voluntary interest. You may be interested in one particular area of research; you can find which studies we are currently recruiting for on our website (https://cenexelresearch.com/rmcr/all-studies/).

Prescreen
After identifying study opportunities that interest you, we will schedule a prescreen via phone or in-person to pre-access your eligibility for a study. This is a great opportunity to meet some of our team who run the studies and will be involved in your care if you do decide to want to take part.

Unfortunately, not everyone is suitable to take part in clinical studies and this will likely be due to a specific criteria required to be fulfilled to take part. The main goal is to ensure participants are kept as safe as possible during a study, and therefore, strict criteria are put in place to ensure that your health and wellbeing is considered in all aspects.

If you are unable or uninterested in taking part at the time of the initial conversation, this doesn’t mean you will never be suitable. We will ask if you consent to us keeping your information on our secure database so that we can contact you about any future trials.

Informed Consent From
Once we identify a study you may be eligible for, we will give you an Informed Consent Form (ICF) for you to review at home. An ICF will run through all necessary information about the study, investigational medication, and placebo so you can make an informed decision on whether you want to participate.

Screening Visit
The screening visit is the first part of a clinical trial. This is where a member of the study team will go through the Informed Consent Form (ICF) with you again and when you ae happy to proceed and have signed the consent form, you are officially a participant in the clinical trial. Remember, you can withdraw from the study at any point, and for any reason, during any stage of the clinical trial.

This visit will normally also include an extensive medical check-up that may include tests and assessments such as urine and blood tests, memory assessments (for memory studies), ECGs, and neurological examinations amongst others. There may also be further tests required such as MRI, PET, DAT scans, or additional memory assessments. Every aspect of the trial and the assessments included will be explained to you in detail at the ICF stage of the visit.

Randomization Visit
After your eligibility is confirmed by the results of the screening assessments, you will proceed to the treatment part of the study which is called randomization. This is where you will be assigned a treatment course, which may be placebo or investigational medication. Our trials are double-blinded meaning you nor our team know whether you are on placebo or active medication.

During the randomization visit, there may be additional tests to ensure safety and to check for consistency in your previous medical assessments. For example, you might be asked to fill in a questionnaire or have blood samples taken. These are used as a record for researchers to compare the before and after effect of the medication you received.

Study Visits
Following randomization, we may schedule multiple visits which may be in-person, at home, or over the phone. This is to monitor your safety for the duration of the treatment period of the study. At these visits you will receive the study medication in its chosen form. This is either as oral medication, infusion, vaccine, or other methods to be given on site or to take home with you for continued treatment. A member of the study team will explain how and when to take your medication in detail.

Follow-Up Care
After the treatment period has ended, there is a follow up period. This is where we will assess how you are doing after finishing taking study medication. This may be through in-person visits and phone calls to make sure you receive adequate follow-up care, which may include us sending some recommendations to your primary care provider.

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