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Long-term follow-up of a lifestyle program for people at risk of Alzheimer's disease

Follows people with memory worries and the APOE-ε4 gene after a lifestyle program.

Plain-language title generated from the registry record
Registry title: PENSA+: Extended Follow-up of a Multimodal Lifestyle Intervention to Prevent Cognitive Decline in APOE-ε4 Carriers

Key facts

Where
Barcelona, SpainSee the site

Where in Spain

  • Fundació Pasqual MaragallBarcelona, SpainNo longer taking part

Questions to ask the study team

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  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Trial code
NCT07730671
Record updated
28 July 2026
Original description
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.Read full original descriptionShow less

Evaluation of the Long-Term Cognitive, Biological, and Lifestyle Effects of a Multimodal Intervention for Preventing Cognitive Decline in APOE-ε4 Carriers With Subjective Cognitive Decline

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.

Inclusion: 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: A prior clinical diagnosis of dementia, regardless of etiology; 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; Participants will be excluded from the study if they meet any of the following conditions:; 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).

ClinicalTrials.gov NCT07730671