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Clinical study in Parkinson's disease with two unique goals: 1) Proof-of-concept of CDNF protein for disease modification; 2) Validation of clinically tested device for intracerebral drug delivery

Deliverables

CDNF efficacy dataset

Clinical proof-of-concept efficacy dataset for CDNF in PD. Exported from the clinical study database, summarised to assess the efficacy of CDNF, to be published in a scientific journal or other means to be eventually decided by the responsible partners.

Safety dataset

Safety dataset from the clinical study as tables exported from the database, summarised to assess the safety in the clinical study, to be published in a scientific journal or other means to be eventually decided by the responsible partners.

CDNF commercialisation agreement

One of the main goals of the project is to sign a commercialisation agreement on CDNF to ensure its development will continue immediately from the TreatER project to late stage clinical development. Negotiations toward such agreement are confidential business information of Herantis however the outcome shall be published if such an agreement is reached.

DDS validation dataset

Validation dataset for DDS for intracerebral infusions. Exported from the clinical study database, summarised to assess the functionality of DDS, to be published in a scientific journal or other means to be eventually decided by the responsible partners.

ER stress marker manuscript

Scientific manuscript summarising the methods and results of the completed research on ER stress marker changes in Parkinson's disease brains. The manuscript will be submitted in a scientific journal or published via other means to be eventually decided by the responsible partners.

Midterm progress report WP4

The midterm progress report is intended to provide the consortium coordinator, partners, and the commission an update on the progress with scientific research in this WP, to ensure that the goals of the WP are still within reach and the common goals of the consortium remain in consideration.

Midterm recruitment report, extension study

The midterm recruitment report of the extension study will provide a status update on patient recruitment at 20 months after the TreatER project started. This deliverable follows the requirements by the European Commission / Horizon 2020 funded clinical studies.

Report on status of posting results

Report on status of posting results (only in case the results have not been posted in a registered clinical trial database by the end of the project). This is a deliverable required by the European Commission.

CDNF manuscript

Scientific manuscript summarising the methods and results of the completed research on CDNF, MANF and aSyn levels in Parkinson's disease brains. The manuscript will be submitted in a scientific journal or published via other means to be eventually decided by the responsible partners.

Midterm recruitment report

The midterm recruitment report of the primary study will provide a status update on patient recruitment at 8 months after the TreatER project started. This deliverable follows the requirements by the European Commission / Horizon 2020 funded clinical studies.

ER stress-related protein manuscript

Manuscript: ER stress-related proteins in CSF of PD patients Scientific manuscript summarising the methods and results of the completed research on ER stress related proteins in CSF (cerebrospinal fluid) in Parkinson's disease patients. The manuscript will be submitted in a scientific journal or published via other means to be eventually decided by the responsible partners.

Patient information website

"A patient information website (which may also be implemented as a new dedicated section on an already existing website) will be set-up to increase public awareness of the research and to ensure full visibility to its progress as far as possible considering confidentiality of some of the data, and on the other hand to the extent accepted by ethics committees and other regulations. It will be carefully noted that ""advertising"" of a clinical study requires ethics committee approvals."

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