What are neurodegenerative diseases?
Neurodegenerative diseases are those pathologies in which there is an increase in neuronal death, causing deficits in memory, behavior, alterations in movement, etc. The most frequent are Alzheimer’s disease and Parkinson’s disease. These are invalidating and progressive pathologies that affect the quality of life of patients and their closest relatives, and for which, at present, only symptomatic treatments are available, which do not act on the cause or origin of the disease.
In recent years the pharmaceutical industry is investigating promising drugs that try to avoid the progression of symptoms, acting on the causes of the disease and directing its action in the first links of the disease. Through different research units, distributed internationally, the suitability of these drugs is investigated and the possibility of participating in top-level clinical trials is offered to patients.
What is a Clinical Trial?
A clinical trial is an experimental evaluation of a product or medication that aims to assess its efficacy and safety in its application to human.
A clinical trial is performed only when there is reason to believe that the treatment being studied may be beneficial for the patient. The treatments used in clinical trials can show real benefits with respect to current therapies.
Researchers carry out studies to know the usefulness and mechanism of action of the new treatment. If the effectiveness is greater than other treatments already available, the side effects are less than conventional treatment, that is, if the benefits outweigh the side effects, it means that the new treatment is more useful.
In order to answer these questions, the participation of patients interested in evaluating drugs in the experimental phase that are not yet commercialized or available in the health system is essential.
Who can participate in a Clinical Trial?
Clinical trials are open to anyone who wants to participate and meets certain requirements. In particular, any patient who suffers from a certain disease and who wants to contribute to the development of new drugs, particularly if the available treatments are unsatisfactory for this disease.
To participate in them you need to contact us. Once we receive your notification of interest, a visit to our unit will be arranged for information, assessment and advice.
A team member will evaluate your medical history and make a first approximation to the possible clinical trials in which you can participate. Likewise, the entire process and the characteristics of the trial will be explained to him, giving him the informed consent forms for his meditated review.
Once the doubts that you may have been resolved, and if you continue to be interested in participating, you will be cited again to sign the document where you will sign your informed consent to begin all evaluations (clinical history, physical and neurological examination, neuropsychological tests, neuroimaging, nursing procedures such as vital signs, analytical and electrocardiogram) essential to ensure their safety and the suitability of their profile for a specific clinical trial.
It is important to note that your participation in a trial is voluntary and that you can withdraw from the trial at any time, without giving any reason and without this having an impact on your usual medical care . Also, you should know that your participation will not generate any expense but you will not receive any financial compensation. There is an aid for trips to the center.
Are there several types of clinical trials?
International regulations distinguish 4 phases in the development of clinical trials, called phase I, II, III and IV. The latter applies to drugs already marketed and in general are not the focus of our attention.
Phase I applies to the first time a drug is used in humans, to assess its safety. They tend to be brief trials, with few healthy volunteers (altruistic or paid), but they can also be studies in patients with a certain pathology (such as a genetic mutation) or tributaries of using a certain medicine (a new chemotherapy in cancer). In phase II, the aim is to evaluate safety and efficacy, the number of participants is increased and there is usually a search for the optimal dose (analyzing the results of several doses used). In phase III the number of participants is very broad, the optimal dose of the drug in research has already been set and can be very long. They are carried out in a multitude of centers in different countries, following all the bioethical and legal regulations required. They are subject to continuous control, monitoring, auditing and inspection processes by the health authorities.
In science, the results obtained should always be measured and compared with a control group. All the data obtained (for example, analytical results or cognitive scales) must be transformed into numbers that allow for statistical analysis. A group of patients receives the study drug but the control group (in the case of diseases without curative treatment) uses a placebo, an inert substance that allows comparing what beneficial effects, or what adverse effects, are really due, or not , to the therapy used.
What do we do in the UDIC?
All the tests are authorized by the health authorities (European, Spanish and Catalan) as well as approved by the Center’s Ethical Committee (CEIm Grupo Hospitalario Quirónsalud Barcelona). It is always considered that the possible benefits outweigh the risks expected. It must be guaranteed that the patient is fully informed of all the characteristics of the study and must understand that their participation is voluntary, and may withdraw at any time, if that is their will.
After accepting their participation in a trial (through the informed consent process), a diagnosis of “certainty” prior to any treatment is required. This is because, currently, the so-called neurodegenerative diseases (Parkinson’s disease, Alzheimer’s disease) do not have a single diagnostic technique and their diagnostic process is complex, with clinical, neuropsychological, laboratory and diagnostic imaging evaluations. If the patient meets all the inclusion criteria and none of exclusion, it is assigned randomly (and unknown to the patient and to the research team) to one of the assigned treatment arms, either at different doses of the study drug. or a placebo group. The corresponding visits will be carried out following a pre-established plan to evaluate the effectiveness (through scales or various complementary tests) and safety (vital signs, ECG, analytical, neuroimaging techniques, etc.). All serious or unexpected adverse effects must be reported immediately, as well as all the data obtained in an electronic notebook, in order to have global information in real time. The anonymity and privacy of the participants is always maintained. Our research activity cannot be separated from assistance, and in general we collaborate with specialized clinical units, such as Parkinson’s Disease and Movement Disorders Unit, Memory Unit, etc.
We collaborate closely with the Neurology Service of the Hospital Universitari General de Catalunya, which provides assistance to patients with neurological problems of all kinds, both at the hospitalization and outpatient level. Our usual task involves working together and in a multidisciplinary way with other medical specialties, surgical and central services (pharmacy, diagnostic imaging, etc.).
What levels of medical care do we do?
At the clinical level we can differentiate two levels of care: outpatient and hospitalization. In outpatient clinics, patients with diverse pathologies who need a diagnosis, treatment and specific follow-up of their disease are given service. A large majority of patients participating in our unit come from outpatient clinics of the Hospital Universitari General de Catalunya (HUGC), San Rafael Hospital or other collaborating centers. In the area of hospitalization we give support to those patients that require a quick and specific diagnosis or treatment, which due to its characteristics make it unfeasible to be able to organize it at the ambulatory level.
How to visit in our unit?
It is only necessary to contact by telephone or by mail to arrange a medical interview, providing the available medical documentation (medical reports, electronic prescription, analysis, or complementary tests). There is no economic cost for this evaluation, or for participating in research projects.Contact us
What are the main areas of research?
- Mild Cognitive Impairment
- Alzheimer’s disease, in prodromal phase, mild or moderate
- Parkinson’s disease, in early or advanced phase
- Progressive Supranuclear Paralysis
- Restless Leg Syndrome
- X fragile syndrome
- Multiple sclerosis
Do we collaborate with other professionals?
- Neurology, Psychiatry and Psychogeriatric Service, both HUGC and HJSD, as well as other external centers: Sant Andreu Hospital (FSSM), Badalona Serveis Assistencials, Fundació Hospital Asil Granollers.
- Pharmacy service
- Diagnostic Imaging Service (CT, MRI, SPECT, TEP,)
- Clinical analysis laboratory
- Other specialists: Ophthalmology, Dermatology, Cardiology, Internal Medicine
Are there any support for participating in clinical trials?
Participation in a clinical trial is not rewarded, although all visits, complementary tests and treatments are free for patients.
There is compensation for allowances and transportation, always authorized by the ethical committee.
What kind of tests are carried out in the clinical trials unit?
It depends on each protocol. We usually perform scales to evaluate motor symptoms, cognitive status or quality of life. It is also common to determine vital signs, ECG records and laboratory tests. Neuroimaging studies (brain MRI, PET) are frequently performed. Depending on the kind of protocol, it could be carried out: pharmacokinetic tests, use of smart devices, ophthalmological or dermatological assessment, etc.