A multimodal lifestyle intervention complemented with epigallocatechin gallate to prevent cognitive decline in APOE- ɛ4 carriers with Subjective Cognitive Decline: a randomized, double-blinded clinical trial (PENSA study) - 28/08/25
the PENSA working group
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Highlights PENSA Study |
• | We explored the effects of MI combined with EGCG in APOE-ɛ4 carriers with SCD. |
• | Cognitive benefits from EGCG combined with MI persist after 3 months of treatment discontinuation. |
• | Combining lifestyle MI and EGCG shows promise for reducing dementia risk. |
• | EGCG may reduce dementia risk via mechanisms beyond amyloid and tau pathways. |
Abstract |
Background |
The potential of dietary compounds to enhance the effects of multimodal lifestyle interventions (MLIs) on cognition in individuals at high risk of cognitive impairment remains unclear.
Objectives |
To assess whether the addition of a green tea extract enriched with epigallocatechin-3-gallate (EGCG) enhances the effects of an MLI.
Design |
Double-blind, randomized, two-arm, and placebo-controlled trial. Exploratory comparisons were made with a non-randomized group (NRG) receiving healthy lifestyle recommendations. Setting: Population-based study conducted in Barcelona, Spain
Participants |
APOE-ɛ4 carriers aged 60-80 with subjective cognitive decline
Intervention |
A 12-month intensive MLI including dietary counseling, guided physical activity, and cognitive stimulation, combined with EGCG (5-6 mg/kg) or placebo, followed by a 3-month washout.
Measurements |
Primary endpoint was change in the modified Preclinical Alzheimer Cognitive Composite (PACC-exe) score.
Results |
129 participants (65.1% 84 women, aged 66.7±5.5 years) were enrolled (52 MLI+EGCG, 52 MLI+placebo and 25 NRG), with126 (97.7%) included in the modified intention-to-treat analysis. After 12 months, no statistically significant difference was observed between MLI+EGCG and MLI+placebo in the PACC-exe (adjusted mean difference [AMD]: 0.12; 95%CI: -0.01, 0.24; p=0.061). However, participants in the MLI+EGCG group were 2.6 times more likely to show a reliable cognitive improvement. In exploratory analyses following a 3-month washout, the MLI+EGCG group showed significant cognitive benefits compared to the MLI+placebo (AMD: 0.19; 95%CI: 0.06, 0.32; p=0.005). Exploratory comparisons with the NRG also suggested greater gains in cognition and dementia risk reduction in both MLI groups, particularly with EGCG.
Conclusions |
While the primary outcome was not met, this proof-of-concept trial suggests that combining MLIs with EGCG warrants further investigation in larger, confirmatory studies.
Le texte complet de cet article est disponible en PDF.Key words for indexing : Multimodal lifestyle intervention, Prevention, APOE-ɛ4, Epigallocatechin-3-gallate, Subjective Cognitive Decline, Randomized Controlled Trial
Plan
Vol 12 - N° 8
Article 100271- septembre 2025 Retour au numéro
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