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Prevention of cognitive decline in subjective cognitive decline APOE ε4 carriers after EGCG and a multimodal intervention (PENSA): Study design
Forcano L, Fauria K, Soldevila-Domenech N, Minguillón C, Lorenzo T, Cuenca-Royo A, Menezes-Cabral S, Pizarro N et al.. Alzheimer's & dementia (New York, N. Y.), 2021-03-31
Topic: Risk, prevention and care in population studies
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.
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APA 7th
Forcano, L., Fauria, K., Soldevila-Domenech, N., Minguillón, C., Lorenzo, T., Cuenca-Royo, A., et al. (2021). Prevention of cognitive decline in subjective cognitive decline APOE ε4 carriers after EGCG and a multimodal intervention (PENSA): Study design. Alzheimer's & dementia (New York, N. Y.). https://doi.org/10.1002/trc2.12155
Vancouver
Forcano L, Fauria K, Soldevila-Domenech N, Minguillón C, Lorenzo T, Cuenca-Royo A, et al. Prevention of cognitive decline in subjective cognitive decline APOE ε4 carriers after EGCG and a multimodal intervention (PENSA): Study design. Alzheimer's & dementia (New York, N. Y.). 2021. doi:10.1002/trc2.12155. PMID: 33816762.
BibTeX
@article{forcano2021-33816762,
author = {Forcano, L. and Fauria, K. and Soldevila-Domenech, N. and Minguillón, C. and Lorenzo, T. and Cuenca-Royo, A. and Menezes-Cabral, S. and Pizarro, N. and others},
title = {{Prevention of cognitive decline in subjective cognitive decline APOE ε4 carriers after EGCG and a multimodal intervention (PENSA): Study design}},
journal = {Alzheimer's \& dementia (New York, N. Y.)},
year = {2021},
doi = {10.1002/trc2.12155},
pmid = {33816762},
url = {https://doi.org/10.1002/trc2.12155}
}
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Key findings
- Introduction Subjects exhibiting subjective cognitive decline (SCD) are at an increased risk for mild cognitive impairment and dementia.
- The results of the study may aid researchers on the design of future clinical trials involving preventive lifestyle multicomponent interventions.
Why it matters
This paper describes the design of a 12-month trial testing whether a personalized multimodal lifestyle intervention combined with epigallocatechin gallate slows cognitive decline in 200 people with subjective cognitive decline who carry the APOE ε4 allele. No results are reported, so it does not yet show whether this approach prevents cognitive decline.
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Study details
- Participants200
- Evidence strengthHigh
How this study scored 51/100
Published in a leading specialty journal. Scored zero for study design, effect reported and randomized / blinded because the record does not state it. We have no data on senior author's track record, so that was left out: it earned 49 of the 96 points we could judge it on, which is 51 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Alzheimer's & dementia (New York, N. Y.)) |
| Journal's citation record | 1 / 4 | Alzheimer s & Dementia Translational Research & Clinical Interventions: journal h-index 84 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 3 / 5 | 2021 — within 6 year(s) of the newest study here |
| Sample size | 2 / 4 | 200 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomized / blinded | 0 / 2 | No randomization or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | 3 / 7 | Cited 30 times (OpenAlex, 2026-10-10) |
| Citations per year | 2 / 5 | 4.3 citations a year over 7 year(s) since 2021 |
| Impact for its field and year | 2 / 6 | Cited 2.9× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 1 / 6 | Cited by 2 other studies in this library |
| Still being cited | 1 / 4 | Cited 14 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | 1 / 3 | Universitat Pompeu Fabra: institution h-index 747 (OpenAlex) |
| Multicenter collaboration | 2 / 3 | OpenAlex lists 9 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 33816762) |
| Free to read | 2 / 2 | Free to read |
| Points | 49 / 96 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 49 of the 96 points we could judge it on is 51 out of 100. |
| Total | 51 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
- DOI: 10.1002/trc2.12155
- PubMed: 33816762
- Original source →
- Free full text: Alzheimer s & Dementia Translational Research & Clinical Interventions →
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
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