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29/12/2025 - General information

A combination of two drugs and a lifestyle intervention will be tested to prevent dementia.

A team led by Dr. Ana Aldea and Dr. Rafael de la Torre has received a grant of close to €1.3 million to develop a clinical trial that will assess whether a multimodal lifestyle intervention combined with the administration of metformin and epigallocatechin gallate is effective in preventing cognitive decline.

A clinical trial led by a team from the Hospital del Mar Research Institute, in collaboration with Hospital de la Santa Creu i Sant Pau, has received nearly €1.3 million in funding from Spain's Carlos III Health Institute (ISCIII), under the 2025 call of the Strategic Action in Health-Strategic Lines of Health Research. It is one of the 14 clinical trials selected. The trial is led by Dr. Ana Aldea, coordinator of the HMRIB Clinical Research Unit and Head of the Clinical Pharmacology Section at Hospital del Mar, and Dr. Rafael de la Torre, coordinator of the Integrated Pharmacology and Systems Neuroscience Research Group at the Hospital del Mar Research Institute.

The project aims to determine whether combining a lifestyle intervention with two medicines is effective and safe in preventing cognitive decline. This type of combination has already been successful in preventing cardiovascular disease and type 2 diabetes, which share mechanisms of action with dementia. In this case, the goal is to evaluate-through a randomized phase IIb clinical trial-the efficacy of targeting lifestyle factors while adding low doses of metformin, a drug used to treat diabetes, and epigallocatechin gallate (EGCG), a natural derivative of green tea.

To do so, the study will include 240 participants-people at risk of dementia. They will be divided into four treatment groups for 24 months. The lifestyle intervention includes diet, physical exercise, cognitive training, and risk-factor management. Changes in global cognition, functionality, metabolism, and blood biomarkers will be measured. Safety will be assessed through liver and kidney tests and monitoring of adverse effects.

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