Prevention of cognitive decline in subjective cognitive decline APOE ε4 carriers after EGCG and a multimodal intervention (PENSA): Study design
| Autor: | Karine Fauria, Sofia Menezes-Cabral, Thais Lorenzo, Pensa Study Groupǂ, Nieves Pizarro, Rafael de la Torre, Carol Minguillón, Anna Boronat, Aida Cuenca-Royo, José Luis Molinuevo, Laura Forcano, Natalia Soldevila-Domenech |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty Preclinical Alzheimer's disease law.invention 03 medical and health sciences 0302 clinical medicine Physical medicine and rehabilitation Randomized controlled trial law Lifestyle multimodal intervention Medicine Dementia Effects of sleep deprivation on cognitive performance Cognitive decline RC346-429 Research Articles business.industry Prevention RC952-954.6 Cognition medicine.disease Cognitive training Apolipoprotein E ε4 Epigallocatechin gallate Clinical trial Psychiatry and Mental health 030104 developmental biology Geriatrics PENSA study Subjective cognitive decline Neurology (clinical) Neurology. Diseases of the nervous system Randomized clinical trial business 030217 neurology & neurosurgery Stroop effect Research Article |
| Zdroj: | Alzheimer's & Dementia : Translational Research & Clinical Interventions Alzheimer’s & Dementia: Translational Research & Clinical Interventions, Vol 7, Iss 1, Pp n/a-n/a (2021) |
| Popis: | Introduction Subjects exhibiting subjective cognitive decline (SCD) are at an increased risk for mild cognitive impairment and dementia. Given the delay between risk exposure and disease onset, SCD individuals are increasingly considered a good target population for cost‐effective lifestyle‐based Alzheimer's disease prevention trials. Methods The PENSA study is a randomized, double‐blind, controlled clinical trial that aims to evaluate the efficacy of a personalized multimodal intervention in lifestyle (diet counseling, physical activity, cognitive training, and social engagement) combined with the use of epigallocatechin gallate (EGCG) over 12 months, in slowing down cognitive decline and improving brain connectivity. The study population includes 200 individuals meeting SCD criteria and carrying the apolipoprotein E ε4 allele, who will be randomized into four treatment arms (multimodal intervention + EGCG/placebo, or lifestyle recommendations + EGCG/placebo). The primary efficacy outcome is change in the composite score for cognitive performance measured with the Alzheimer's Disease Cooperative Study Preclinical Alzheimer Cognitive Composite (ADCS‐PACC‐like) adding to the original version the Interference score from the Stroop Color and Word Test and the Five Digit Test. Secondary efficacy outcomes are (1) change in functional magnetic resonance imaging (fMRI) and structural neuronal connectivity (structural MRI) and (2) the safety assessment of the EGCG compound. This study is framed within the WW‐FINGERS consortium. Discussion The use of new technologies (i.e., mobile ecological momentary assessments [EMAs], activity tracker) in the PENSA study allows the collection of continuous data on lifestyle behaviors (diet and physical activity) and mood, enabling a personalized design as well as an intensive follow‐up of participants. These data will be used to give feedback to participants about their own performance along the intervention, promoting their involvement and adherence. The results of the study may aid researchers on the design of future clinical trials involving preventive lifestyle multicomponent interventions. |
| Databáze: | OpenAIRE |
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