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NCT07730671
PENSA+: Extended Follow-up of a Multimodal Lifestyle Intervention to Prevent Cognitive Decline in APOE-ε4 Carriers
Conditions: Subjective Cognitive Decline (SCD)
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Enrollment: 121
Sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Location: Fundació Pasqual Maragall Barcelona Catalonia
Summary
PENSA+ is a 5-year follow-up study of participants who previously completed the PENSA clinical trial (NCT03978052), which evaluated an intensive multimodal lifestyle intervention, with or without epigallocatechin gallate (EGCG), in APOE-ε4 carriers with subjective cognitive decline, a population at increased risk of developing Alzheimer's disease.
The purpose of this study is to determine whether the cognitive, biological, and lifestyle benefits observed after the original intervention are maintained over the long term. Researchers will evaluate cognitive performance, the incidence of mild cognitive impairment, dementia risk, brain imaging, blood biomarkers, physical fitness, lifestyle behaviors, and psychosocial factors approximately five years after completion of the intervention.
The study will also investigate the biological and behavioral mechanisms associated with sustained cognitive benefit, identify participant characteristics associated with better long-term outcomes, evaluate the long-term cost-effectiveness of the intervention using healthcare utilization data, and explore whether lifestyle changes have influenced participants' study partners. No new intervention will be administered as part of this follow-up study.
Eligibility Criteria
Inclusion Criteria
\- Any individual who has completed the PENSA study, does not meet any exclusion criteria, and provides consent is eligible to participate in this study.
Exclusion Criteria
Participants will be excluded from the study if they meet any of the following conditions:
* A prior clinical diagnosis of dementia, regardless of etiology.
* Current institutionalization (e.g., residence in nursing homes, long-term care facilities, or similar institutions).
* Impaired decision-making capacity, defined as the inability to provide informed consent independently due to cognitive, legal, or medical reasons (e.g., loss of autonomy or requirement of a legal representative).
* Current participation in another interventional clinical trial, or participation in an interventional clinical trial within the previous 3 months prior to baseline; unless deemed by the investigator not to interfere with PENSA+ procedures or outcomes.
Source: ClinicalTrials.gov (NCT07730671). StuddyBuddy aggregates publicly available trial information.