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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 5 - 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: 2020-09-01 to 2021-08-31

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.
Final project duration has been 63 months, divided in 5 reporting periods (RP) from 2016-06 to 2021-08.

Four pre-serial units were manufactured, validated and are currently installed at four hospitals.

Measured specifications surpass the expected specifications and the existing systems on market.

Pilot Clinical Validation was sucesfuly completed and with encouraging results during initial reporting periods. Stage II Clinical Trial has been the most affected due to COVID-19 pandemic. The clinical results, though still preliminar, demonstrate the clinical value of CareMiBrain system.

Final CE&FDA dossier is completed and ready for product lauch, including final manufacturing documentation and clinical validation as required by the new EU Medical Devices Directive.

The production plan, manufacturing documentation and calibration and manufacturing tools are ready and have been validated assembling a new unit with the existing documentation.

Five new patents were filed and have been granted during this project.

Oncovision has attended or participated in more than 15 events, listed in deliverable D6.5. Event attendance in last two reporting periods was impacted by COVID, which was compensated with marketing activities and active contacts with companies for result exploitation. 7 publications, 3 presentations and mentions in 5 reviews and a book are the final results of the publications. At least 4 more publications and presentations are planned for 2022.

A total of 246 companies, from medical imaging and radiotracer companies to Neurology-focused, pharmaceutical, medical investment groups and even major medical imaging service providers were contacted seeking a corporate or commercial agreement for global launching of Caremibrain. 15 companies are in board level, confidential or contract terms discussions.

During the last period an amendment of the GA has been approved with these these major changes:
- 3 month project extension.
- Project coordinator was changed.
- Scope of clinical study is changed, reducing total number of patients in stage II.
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