NCT07730671Not yet recruiting
PENSA+: Extended Follow-up of a Multimodal Lifestyle Intervention to Prevent Cognitive Decline in APOE-ε4 Carriers
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
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 121 (estimated)
- First submitted
- 20 Jul 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
- Diseases
- Alzheimer disease
- NCT number
- NCT07730671
What you commit to
- Study type: Observational
- Planned participants: 121
- From 1 Sept 2026 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Participants will be excluded from the study if they meet any of the following conditions:
Other
- 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).
Who the study is looking for
- \- Any individual who has completed the PENSA study, does not meet any exclusion criteria, and provides consent is eligible to participate in this study.
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundació Pasqual Maragall Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.