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Published on: August 28, 2018
Observational multicentre prospective study to assess changes in cognitive function in patients treated with PCSK9i.
José Seijas-Amigo1, Diego Rodríguez-Penas1, Ana Estany-Gestal2
1Servicio de Cardiología, Complexo Hospitalario Universitario de Santiago de Compostela (A Coruña). Spain.. jose.seijas.amigo@sergas.es.
This study investigates if PCSK9 inhibitors, used to lower LDL cholesterol, impact cognitive function. Researchers will track cognitive changes and quality of life in patients starting these potent lipid-lowering therapies.
Area of Science:
- Cardiovascular Medicine
- Neuroscience
- Pharmacology
Background:
- PCSK9 inhibitors significantly reduce LDL cholesterol (LDLc), achieving up to 60-85% reduction when combined with statins and ezetimibe.
- Very low LDLc levels achieved with these therapies raise concerns about potential cognitive deterioration, although one study (EBBINGHAUS) found no significant differences.
Purpose of the Study:
- To prospectively evaluate cognitive deterioration in patients initiating PCSK9 inhibitor treatment.
- To assess the repercussions of cognitive changes on patients' quality of life.
- To analyze changes in LDLc levels in conjunction with cognitive and quality of life outcomes.
Main Methods:
- A multicenter, non-randomized, prospective study involving 275 patients initiating PCSK9 inhibitors across 11 hospitals.
- Primary outcome: evaluation of cognitive function changes using the Montreal Cognitive Assessment (MOCA).
- Secondary outcomes: assessment of quality of life (EuroQol-5D) and LDLc levels over a 24-month follow-up period.
Main Results:
- Cognitive function changes will be assessed using the MOCA questionnaire.
- Quality of life will be measured with the EuroQol-5D.
- LDLc levels will be monitored throughout the study.
Conclusions:
- The MEMOGAL study aims to provide crucial safety data regarding cognitive function in patients undergoing treatment with PCSK9 inhibitors.
- Findings will inform clinical practice on the cognitive safety profile of PCSK9 inhibitors.
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