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PENSA (Spain)

PENSA is a randomized placebo-controlled trial which combines a multimodal lifestyle intervention with the taking of a dietary supplement, epigallocatechin gallate (EGCG), a natural compound from green tea. The study aims to investigate whether this combination can improve the cognitive function of the study participants before the appearance of the first symptoms of Alzheimer’s disease.

The study, which started in 2019, includes 129 participants aged 60 years or older who are ApoE 4 carriers and experience subjective (self-reported) cognitive decline. Participants were randomized into three study arms. Two arms participated in the intensive lifestyle intervention program, with either EGCG or placebo. The intervention included dietary guidance, physical activity, and cognitive stimulation. The third arm received lifestyle recommendations. The study ended in July 2023 and had a duration of 12 months with a 3-month follow-up period. Results have not yet been published.

The primary outcome is the global cognitive composite score. Secondary outcomes include the change in brain connectivity, evaluated with functional neuronal connectivity, fMRI, and structural connectivity, MRI. The results will help facilitate the development of effective multimodal interventions to prevent or delay the onset and progression of late-life cognitive impairment, Alzheimer’s disease, and dementia.

In previous studies, EGCG has shown positive effects on the cognitive function of people with Down Syndrome, in combination with a cognitive stimulation program.

PENSA is a collaboration between the Hospital del Mar Medical Research Institute and the Barcelonabeta Brain Research Center. It is primarily funded by the Alzheimer’s Association, with additional support from the Spanish Ministry of Science, Innovation and Universities (Instituto de Salud Carlos III).

PENSA: Description of baseline demographic and neuropsychological data of the study population