Retrospective study on HDT officially started!

After months of planning, discussion, and collaboration, we are thrilled to officially announce the launch of a new research project:
“Retrospective Study on Defining Parameters for Initial Thiamine Dosage in Patients with Parkinson’s Disease.”

This important study marks a significant step forward in our collective effort to better understand how thiamine (vitamin B1) can be effectively used to support people living with Parkinson’s Disease. The research will be conducted in collaboration with the San Martino Hospital of Genoa, Italy, a leading institution in neurological and clinical research.

The study is funded by the HDT Foundation, made possible through the generous contributions collected via the dedicated GoFundMe campaign. We are deeply grateful to every donor whose support is helping turn this initiative into reality.

This retrospective study aims to analyze patient data to identify the key parameters that define optimal starting doses of thiamine in Parkinson’s treatment protocols. By establishing evidence-based dosage guidelines, we hope to contribute meaningful insights to the scientific and medical communities—and ultimately, to improve patient care and outcomes.

We look forward to sharing updates as the study progresses and to keeping our community informed about the findings and their implications.

The retrospective study is the first step into getting a full fledge FDA and EMA approval for the HDT protocol for PwP. We are only at the beginning of this journey! Together, we continue to move closer to better understanding and managing Parkinson’s Disease through science, collaboration, and hope.

Thank you for your support.

– The HDT Foundation Team

More details about the study design:

The study aims at defining the parameters that influence the initial effective dosage of thiamine in the context of the High Dose Thiamine protocol developed by Dr. Antonio Costantini.

This retrospective study uses the Principal Investigator expert opinion (= experience) + patients’ charts and hospital records to identify those factors which influence thiamine start dose, and develop draft thiamine dose reference table based on these assessments.

The validated dose table will represent the basis for the dose finding phase of a subsequential RCT study.

To date, the only institution that keeps sufficient records over a large sample of PwP treated with the HDT protocol is the San Martino Hospital of Genoa, specifically the department of Neurology of Dr. Roberto Fancellu. Dr. Fancellu is the Principal Investigator for this study.

Technical staff for the work to be carried out include a Neurologist and an Assistant with a background in statistics applied to neurological studies. These professionals will be recruited by the San Martino Hospital for the specific purpose of carrying out this study. Additional funding to cover these two positions was provided by the HDT Foundation ETS, through the donations collected via the GoFundMe campaign and generous contributions of several donors.

Study-dedicated staff recruitment will last, according to the Hospital’s internal procedure as set by the law, approximately 60 days (8 weeks) from the receipt of the initial batch of funds.

The study will start once staff recruitment is completed and will require a total of 4 months. At the end of this first phase of the study the PI and collaborators will draft an interim report with initial findings. The Neurologist and the Assistant will firstly collect and examine the records of around 200 patients with PD treated in the recent past with the HDT protocol. They will be guided by the PI on the evaluation and selection of key determinants and relevant aspects to feed into the dose table. Once the screening of defining characteristics of each patient is completed, the team will establish phone contacts with the patient (or his/her caregiver) to verify the information and the effective thiamine dosage and means of administration (i.e. oral vs intramuscular). Separated dosage tables will be produced according to the different administration route. Once the data collection and cleaning are completed, the team will derive a first iteration of a dose table informed by statistical analyses applied to the relevance of each parameter taken into consideration.