Innovation comes to Alzheimer’s disease.
Alzheimer’s disease (AD) is the most relevant neurodegenerative disease. Worldwide, nearly 36 million people have Alzheimer’s or a related dementia which will double every 20 years to 115.4 million in 2050, and in Europe affects about 7.5 million people (75% of all dementia cases) and is expected to increase up to 10.5 million in 2030, with a reported prevalence rate of 6.2% for all those aged 60 years and over. Only 1-in-4 people with AD have been diagnosed. For the fast ageing populations of the Western societies, AD is becoming one of the main public health concerns, associated with a social and economic burden, and the provision of care for people with AD is a complex and costly issue. At present, there is not any therapy that can effectively cure the disease since it is a complex disorder of which the exact cause is still not known.
The aproach to Alzheimer´s disease is changing gloabally. Oncovision’s plan, is to develop a new brain-dedicated PET that offers a valuable alternative to currently available whole-body PET systems.
Caremibrain fulfils the necessities of neurologists and nuclear physicists regarding the β-amyloid radiotracers and the firsts true effective drugs against Alzheimer disease in its final development stage (Aducanumab –Biogen–; Azeliragon –Pfizer–; Gantenerumab –Roche–, Solanezumab –Eli Lilly–, Verubecestat –Merck–).
In 2019, the pilot study for the technical validation of the equipment was successfully completed, which consisted of a prospective and observational study on 40 patients, whose objective was to obtain the first images, analyze them and make adjustments in acquisition, reconstruction and correction parameters, comparing the image quality of the CareMiBrain equipment with that of the full-body PET-CT equipment.
The second phase of the study is currently underway, which is an international multicenter study, in which, in addition to the Hospital Clínico San Carlos in Madrid, the UKT University Hospital in Tübingen, Germany, the Massachusetts General Hospital in Boston, USA, and the Hospital Universitario y Politécnico La Fe in Valencia, Spain, will participate. At the end of the multicenter study, the number of patients will reach 300.
This second phase of the study will make it possible to establish the clinical contribution of this equipment through the comparative evaluation of the image and quantification generated by CareMiBrain, compared to the standard brain image obtained with the full-body PET CT in use in each center, in patients with neurological pathologies who undergo this test by prior medical indication. The CareMiBrain project is funded by the European Union under the Horizon 2020 innovation program.
Caremibrain fulfils the necessities of neurologists and nuclear physicists regarding the β-amyloid radiotracers and the firsts true effective drugs against Alzheimer disease in its final development stage (Aducanumab –Biogen–; Azeliragon –Pfizer–; Gantenerumab –Roche–, Solanezumab –Eli Lilly–, Verubecestat –Merck–).
The Hospital Clínico San Carlos leads a clinical trial to validate CareMiBrain with the focus on its commercialization in Europe at the end of this year. The clinical trial has two phases; the first one is done in exclusive in this public hospital of Madrid and is a descriptive, prospective and observational pilot study to compare and validate the image quality of the new PET in comparison to conventional WB-PET in 40 patients. For this task, two Nuclear Medicine physicians will compare and analyze separately, and without clinical information or previous diagnosis the results of the images provided by the conventional WB-PET and the dedicated brain PET.
Once this phase is validated and with CE mark for its comercial use, a new multicentric international study will start and will be lead by the Hospital Clínico San Carlos with 100 patients. Three others worldwide known hospital from Europe and United States as Tübingen Hospital in Germany, Massachussets General Hospital, in Boston; and Hospital Universitario La Fe in Valencia, will participate to reach a total of 310 patients. This clinical trial has received foundings from the European Union Horizon 2020 research and innovation program.
Benefits
Its high resolution and greater sensitivity will provide greater precision and diagnostic capacity in all clinical applications in which molecular imaging plays a key role, such as neurodegenerative diseases (dementia, multiple sclerosis, Parkinson’s disease…), neurovascular diseases, tumors or functional or psychiatric diseases (epilepsy, schizophrenia, autism…).
Moliner, L., Rodríguez-Alvarez, M.J., Catret, J.V. et al. NEMA Performance Evaluation of CareMiBrain dedicated brain PET and Comparison with the whole-body and dedicated brain PET systems. Sci Rep 9, 15484 (2019). https://doi.org/10.1038/s41598-019-51898-z
CareMiBrain provides valuable information in early stages of the disease that no other imaging technique is able to provide, as it is able to detect and visualize brain disease patterns before any structural change has been detected.
The high sensitivity of the equipment makes it possible to use a minimal dose of radiotracer and reduce scanning time, increasing the number of patients who can undergo the test, as well as their safety and comfort. The patient adopts a seated position, much more relaxed, which avoids the claustrophobia of other tests such as MRI and wbPET.
Thanks to the low radiotracer dose and high resolution, CareMiBrain can be the perfect system for monitoring neuro-oncological applications such as brain tumors, as well as therapy follow-up.
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 711323.
