The FPS Public Health and FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified medicine PR006A to treat frontotemporal dementia with progranulin mutations (FTD-GRN). The public consultation will run from 28 July 2021 to 27 August 2021.
For each clinical trial application related to the use of genetically modified organisms, the authority organises a 30-day public consultation (in accordance with the Royal Decree of 21 February 2005). This gives you the opportunity, as a citizen, to share your opinion on the clinical trial application for the genetically modified medicine PR006A to treat frontotemporal dementia with progranulin mutations (FTD-GRN).
Frontotemporal dementia (FTD) or frontotemporal lobar degeneration refers to a group of disorders caused by progressive cell loss in the brain's frontal and temporal lobes. These areas of the brain play a significant role in making decisions, behavioral control, emotion, and language.
Mutations in the progranulin gene (GRN) are a common genetic cause of FTD. The GRN gene has the genetic code to make progranulin (PGRN) protein. In patients with GRN mutations, PGRN protein is significantly reduced and it is believed to be the cause of FTD symptoms.
In the clinical trial, fifteen patients, including about two patients in Belgium, will be administered a one-time dose of PR006A (low, mid, or high dose).
The main objective of this trial is to evaluate the safety, tolerability and immunogenicity of the three dose levels of PR006A and to register PGRN levels in blood and cerebrospinal fluid.
The clinical trial will take place at Leuven University Hospital.
How can I share my opinion?
The public consultation runs until 27 August 2021 inclusive. You can access the various data in the application file (in French), as well as an online form to send your comments or ask your questions about this file.
General information on public consultations on GMOs (in French).