Ambar® has two phases. It begins with an intensive phase lasting six weeks, followed by a maintenance phase, the duration of which will be determined by medical criteria. Follow-up visits with the neurologist are scheduled every three months.

Before the procedure, the person will have a blood test to check that they are suitable for the session. During the procedure, the person will lie comfortably in a reclining chair and a specialized healthcare professional will connect them to the plasma replacement device via a vein in their arm. They will be under constant medical supervision throughout the procedure. All medical equipment that comes into contact with blood is disposable and sterile. A member of the Therapeutic Apheresis Unit team will follow up with the patient 24 hours later.

Anyone wishing to undergo the procedure must attend an informative consultation with the neurologist and undergo additional tests if requested by the professional. If suitability for the procedure is confirmed, the first phase of AMBAR® begins.

Plasma therapeutic replacement is a very safe procedure for everyone, and after the treatment protocol, you will be able to resume your normal daily activities. As a precaution, you should only limit intense physical activity for 24 hours after the procedure. In addition, a member of the Unit team will monitor your condition during the following day.

Albumin is the most abundant protein in plasma and, among other functions, serves to transport substances through the bloodstream. It also transports beta-amyloid protein, which accumulates in the brains of people with Alzheimer’s disease, forming plaques that destroy neurons. Therefore, if we periodically extract this plasma, we could eliminate beta-amyloid, limiting the impact of Alzheimer’s disease on a person’s cognitive functions.

Plasma exchange is a medical procedure that has been used for decades in the treatment of multiple neurological diseases and other conditions, such as kidney disease and Crohn’s disease. It involves extracting blood from the patient using a medical device that separates the different components: plasma (the liquid part of blood) and blood cells (red blood cells, white blood cells, and platelets). The extracted plasma is replaced with albumin, which is administered to the patient along with the blood cells.

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If you’re interested in participating in a clinical trial, you first need to find out whether you meet the eligibility requirements and whether it’s right for you. Keep in mind that each trial has its own rules regarding who can participate (for example, some are aimed at early stages of the disease and others at more advanced stages depending on the drug’s mechanism of action).

Additionally, consult your doctor to determine if a particular clinical trial is right for you. If you meet the inclusion criteria, they will explain all the details of the clinical study to you, such as the study’s duration, number of visits, a description of the procedures, as well as the risks, benefits, and requirements for participation. Once you have started participating in a trial, you are free to withdraw at any time.
You will then be asked to sign an informed consent form to document that you understand what the trial entails, that any questions have been answered, and that you are willing to participate.

No. Medical care related to the clinical trial includes consultations, treatments, and study procedures. In addition, transportation expenses and other costs incurred during visits to the center are covered.

The duration and number of visits for each trial vary depending on the study’s objective. Some last a few months and others several years. If you participate in a clinical study, you can withdraw at any time.

Participants will have the opportunity to access new treatments and innovative diagnostic techniques currently unavailable to the general population, which could help manage the progression of the disease and improve quality of life. They will receive more comprehensive and personalized medical monitoring with more frequent check-ups. In addition, participating in a clinical trial will help others with the same condition in the future by providing valuable data on treatment advances and on Alzheimer’s disease.

Drugs must go through different stages before being approved. First, they are evaluated in in vitro (laboratory) and preclinical (i.e., animal) models to determine whether these molecules are safe and whether they impact the pathological processes described in the disease. For example, in the case of Alzheimer’s disease, the investigational products are evaluated for their ability to prevent the accumulation of amyloid plaques in the brain or to improve animals’ memory. In this way, drugs in clinical development in humans go through Phase 1, 2, and 3 clinical trials, where each time a larger number of subjects are exposed. In Phase 1 clinical trials, a small number of people (usually fewer than 100) are exposed; the drug’s concentration in the blood is studied, its adverse effects are assessed, and different doses are evaluated. Next, in Phase 2 trials, a larger number of participants (typically between 100 and 400) are exposed to the drug, different doses are evaluated, and its safety continues to be studied.At this stage, the drug’s impact on various disease indicators is already being evaluated. Finally, in Phase 3 clinical trials, we will evaluate its clinical efficacy and continue to study its safety. All clinical trials involving a drug must be approved by the strict standards of the Spanish Agency for Medicines and Health Products (AEMPS), an entity that evaluates the proper conduct of these studies, reviews the correct production of the investigational product, ensures that the benefit/risk of the proposed clinical trial is coherent, that the professionals participating in the clinical trial are adequately qualified, and that the people who decide to participate are treated with the highest possible safety. They must also be approved by an ethics committee. Before participating in a clinical trial, a comprehensive examination is conducted to minimize risks during participation. The results of all tests must fall within normal ranges; otherwise, the person cannot participate. All of this does not preclude potential risks from arising during their participation in the study. In this regard, all participants must sign an informed consent form in which the participant explicitly acknowledges their understanding of the risks and benefits involved in participating in a study.

Clinical trials are studies designed to understand the effects of a drug or investigational procedure. To participate in one of these trials, certain procedures must be carried out, which will depend on each research protocol.
In clinical trials for diseases involving cognitive impairment, it is almost always necessary to involve a close personal caregiver (a family member or close friend) who is asked questions to objectively assess the progression of the disease. The patient and their companion will be required to attend the study visits and must inform the trial doctor of any changes in their life that they believe could impact the study’s results (changes in medication, scheduling of surgeries, etc.) or any possible side effects that may arise.
Participation in a research study is free and voluntary. All information collected during the study will be treated confidentially.  More about clinical trials