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
Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Global Cognitive Performance (PACC-exe Composite Score) — Baseline, 12 months, and approximately 5 years after completion of the original PENSA intervention Global cognitive performance assessed using the Preclinical Alzheimer Cognitive Composite for executive function, a composite score derived from six neuropsychological tests: Montreal Cognitive Assessment (score 0-30, higher scores indicate better cognition), Free and Cued Selective Reminding Test (score 0-48, higher scores indicate better episodic memory), Logical Memory Delayed Recall from the Wechsler Memory Scale (score 0-48, higher scores indicate better delayed verbal memory), WAIS-IV Coding (higher scores indicate better processing speed), Stroop Color-Word Test Interference score (higher scores indicate better inhibitory control and executive function), and Five Digit Test (higher scores indicate better executive functioning and cognitive flexibility). Individual test scores are converted to standardized z-scores based on the baseline mean and standard deviation of the study cohort, and the PACC-exe score is calculated as the arithmetic mean of these z-scores.
Incidence of Mild Cognitive Impairment (MCI) — Approximately 5 years after completion of the original PENSA intervention Incidence of Mild Cognitive Impairment determined according to clinical diagnostic criteria based on neuropsychological evaluation and clinical assessment performed at the 5-year follow-up visit.
Diagnosis will require: (1) evidence of objective cognitive impairment on standardized neuropsychological assessment; (2) reported cognitive decline from previous functioning by the participant, an informant, or documented longitudinal assessment; (3) preserved independence in activities of daily living (impaired performance will be defined as below the 10th percentile, scaled score \<7, or ≥1.3 SD below age- and education-adjusted normative means); and (4) absence of dementia. Domain-specific impairment will be defined as low performance in ≥3 of 5 memory measures, ≥3 of 5 executive function measures, or ≥2 of 2 language measures. Final diagnosis will be established by a neurologist based on the integrated evaluation of neuropsychological, clinical, functional, and behavioral information.
Dementia Risk (LIBRA Index) — Baseline, 12 months, and approximately 5 years after completion of the original PENSA intervention Dementia risk assessed using the Lifestyle for Brain Health (LIBRA) Index, a weighted composite score of modifiable risk and protective factors for dementia. Lower scores indicate lower estimated dementia risk.
The dementia risk assessed with the LIBRA Index is a weighted composite score of 12 modifiable risk and protective factors for dementia. These modifiable risks are the following:
1. Coronary heart disease
2. Chronic kidney disease
3. Hypertension
4. Hypercholesterolemia
5. Diabetes
6. Depression
7. High cognitive activity
8. Obesity
9. Low/moderate alcohol use
10. Physical inactivity
11. Smoking
12. Healthy diet
Trial sites (1)
Facility
City
Region
Status
Fundació Pasqual Maragall
Barcelona
Catalonia
More Barcelonabeta Brain Research Center, Pasqual Maragall Foundation trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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