PENSA+: Extended Follow-up of a Multimodal Lifestyle Intervention to Prevent Cognitive Decline in… (NCT07730671) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
PENSA+: Extended Follow-up of a Multimodal Lifestyle Intervention to Prevent Cognitive Decline in APOE-ε4 Carriers
Spain121 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial specifically targets people who carry the APOE-ε4 gene and are experiencing subjective cognitive decline, would it be worth getting genetic testing to see if I even have the APOE-ε4 variant before we discuss whether this study might be relevant to my situation?
2This trial is listed as 'not yet recruiting' — given that timeline uncertainty, should I be starting any lifestyle-based strategies now, or would it make sense to wait and potentially join a structured program like this one when it opens?
3The study is measuring something called the PACC-exe composite score to track global cognitive performance over time — is that kind of cognitive testing something you'd recommend I do regardless of whether I join this trial, so we have a baseline to compare against?
4Since this is a lifestyle intervention study rather than a drug trial, what does that mean in terms of what would actually be asked of me day-to-day, and how demanding do you think that kind of commitment realistically is for someone in my situation?
5The trial is also tracking dementia risk using something called the LIBRA Index, which I understand looks at modifiable lifestyle factors — are there things on that index I should already be working on with you now, whether or not I end up participating in this study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Global Cognitive Performance (PACC-exe Composite Score)
Timeframe: Baseline, 12 months, and approximately 5 years after completion of the original PENSA intervention
2
Incidence of Mild Cognitive Impairment (MCI)
Timeframe: Approximately 5 years after completion of the original PENSA intervention
3
Dementia Risk (LIBRA Index)
Timeframe: Baseline, 12 months, and approximately 5 years after completion of the original PENSA intervention
Trial details
NCT IDNCT07730671
SponsorBarcelonabeta Brain Research Center, Pasqual Maragall Foundation