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A new brain-dedicated Positron Emission Tomography (PET) system to identify β-amyloid biomarker for the early diagnosis of Alzheimer’s disease and other causes of cognitive decline

Periodic Reporting for period 3 - CAREMIBRAIN (A new brain-dedicated Positron Emission Tomography (PET) system to identify β-amyloid biomarker for the early diagnosis of Alzheimer’s disease and other causes of cognitive decline)

Reporting period: 2018-06-01 to 2019-05-31

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. In Europe, it affects about 7.5 million people (75% of all dementia cases).

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.

Given that AD is the highest ticket health and social care item that we have, making up 60% of long term care spending according to some estimates, then targeted investment in early intervention and in research (into causes, cure and care) are likely to be of major value in personal, societal, political, and economic terms.

This brain-dedicated Positron Emission Tomography (PET) tackles some of the key issues highlighted by the European initiative on Alzheimer’s disease, especially those related to early diagnoses of Alzheimer’s disease, improved understanding of dementias and good practices with regard to diagnosis, treatment and financing of therapies for these conditions.

CareMiBrain, the ONCOVISION’s new brain-dedicated PET—which is going to be validated, produced and commercialised in this innovation project—solves the stated problem in the following way:

a) PATIENT will:

• Allow an early detection of AD and other causes of cognitive decline: early planning and assistance, help in the management of other symptoms which may accompany the early stage of AD, and rule out reversible and treatable causes of dementia. It also offers more opportunities to participate in clinical trials, some involving new drugs which could be more effective. Non-drug intervention can also delay and slow progression, provides time to record memories, and offers caregivers more understanding and patience, qualifying for disability if still working. Besides, it provides time to identify and address safety concerns, become informed about what to expect, and benefits for support groups.
• Facilitate the treatment efficacy tracking.
• Use a lower radiotracer dose to the patient.

b) HEALTH SYSTEM will:

• Reduce costs of PET equipment as this new system will cost up to 3 times less than whole-body PET systems.
• Reduce costs of hospital facilities as our brain-dedicated PET needs smaller rooms with lower construction costs.

c) SOCIETY will:

• Contribute to reduce societal cost per patient slowing the evolution of AD and maintaining the patient with mild symptoms as long as possible.

The main objectives of this project are to market an innovative brain-dedicated PET system to facilitate the early diagnosis of Alzheimer’s disease (AD) and other causes of cognitive decline.

The expected outcomes of this project are the clinical validation and commercialisation of a new PET system that will push the resolution to the physical limit, while increasing its sensitivity three times with respect to current whole-body PET systems; and offering a competitive price, three times lower than other whole-body PET systems developed by large manufacturers.

This system could be also used in different clinical situations to support the assessment of other critical neurological disorders different from AD (or conditions related to cognitive decline), as epilepsy, brain tumour, local neuroinflammation, cerebral ischemia or phobias.

Therefore, this brain-dedicated PET needs smaller and, for that reason, cheaper hospital facilities to perform its diagnostic function. Other advantage related to its high sensitivity is the need of a lower radiotracer dose that has an impact on reduced tracer cost and less radiation to the patient.
During the firsts 36 months of the project, ONCOVISION has manufactured satisfactorily three fully functional units of the dedicated brain PET CareMiBrain. The results of the in-vitro tests performed up to date are excellent and fulfills the expected specifications.

The new system has passed the electromagnetic compatibility and electrical safety trials according to rigorous international standards for medical devices.

The documentation of fabrication/QA and validation of the calibration and manufacturing tools are almost complete taking advantage of the manufacture of Unit 4. Most of the CE Mark dossier has been also created.

During this reporting period, Pilot Clinical Trail Validation has been finished at Hospital Clínico San Carlos (HCSC) with satisfactory results related with equipment performance, patient comfort and initial images quality. Forty patients have been scanned and the main researchers are very excited to start phase II and make a quantitative comparison of the CareMiBrain images with the gold standard.

Clinical trials will start in the coming months and the 4 institutions are ready to start. Oncovision is carrying out the last Ethical Committees requirements in order to be able to send the devices and start the Clinical Studies.

During the last period an amendment of the GA has been approved with these three major changes:
- Substitute two clinical subcontractors
- Time extension
- Adding two subcontractors

The project is having a wide visibility in internet and the social networks. It has been also present in several international scientific and medical congresses.
In-silico and In-vitro tests results are very promising. ONCOVISION, in close collaboration with the Instituto de Instrumentación para Imagen Molecular (I3M), has developed, manufactured and integrated an advance PET detector system based on proprietary technology, continuous scintillating crystals and silicon detectors. These detectors offer big advantages respect to currently commercialized technology in terms of resolution, sensitivity, cost, size and maintenance. The compact acquisition electronics, fully developed in-house, together with innovative high-performance processing algorithms, makes CareMiBrain a new reference in PET systems.

A high resolution and sensitivity, small footprint and reduced cost dedicated brain PET will make the brain imaging more affordable to many institutions, allowing to perform this important diagnostic instrument to more patients.

The high sensitivity of the system will permit to reduce the radiactive dose to the patient, the cost of the radiotracer and the acquisition time.

A brain PET imaging more accessible and safe, will aim to early diagnoses of Alzheimer’s disease, improved understanding of dementias and good practices regarding diagnosis, treatment and financing of therapies for these conditions.
CAREMIBRAIN Prototypes