PENSA+: Extended Follow-up of a Multimodal Lifestyle Intervention to Prevent Cognitive Decline in APOE-ε4 Carriers
NCT07730671, Not yet recruiting, Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | PENSA+: Extended Follow-up of a Multimodal Lifestyle Intervention to Prevent Cognitive Decline in APOE-ε4 Carriers | ClinicalTrials.gov |
| NCT number | NCT07730671 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 121 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Barcelonabeta Brain Research Center, Pasqual Maragall Foundation | ClinicalTrials.gov |
| Conditions | Subjective Cognitive Decline (SCD) | ClinicalTrials.gov |
| First posted | 2026-07-28 | ClinicalTrials.gov |
| Last updated | 2026-07-28 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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 | ClinicalTrials.gov |
| Secondary | Longitudinal changes in memory and executive function | Baseline, 12-month, 5-year | Longitudinal changes in cognitive domains (memory and executive function scores, PMCID: PMC12413734). | ClinicalTrials.gov |
| Secondary | Longitudinal changes in Mediterranean diet adherence | Baseline, 12-month, 5-year | Diet will be assessed through Mediterranean Diet Adherence Screener (MEDAS-14). The MEDAS-14 is a 14-item questionnaire for the assessment of Mediterranean diet compliance. It has been developed and validated by researchers of the PREDIMED study (PMCID: PMC8710807). The maximum possible score is 14 points. This questionnaire allows the participants to be classified according to their adherence to the Mediterranean diet, being appropriate if the score is ≥10 or not appropriate if the score is \<10. | ClinicalTrials.gov |
| Secondary | Longitudinal changes in physical activity | Baseline, 12-month, 5-year | Physical activity is measure through the Short Minnesota Leisure Time Activities Questionnaire (VREM). The VREM questionnaire asks for information on six activities carried out in the last month (or usual month) in order to find out the level of PA performed: walking, gardening in the garden, doing sport or dancing, climbing stairs, shopping on foot, and cleaning the house. cleaning the house (PMID: 23223762). According to the number of minutes spent on each activity and the frequency they are carried out over the course of a year, the energy expenditure is estimated for 14 days, expressed in Metabolic Equivalents (METs) per minute per 14 days (MET-min-14 days). The VREM makes it possible to distinguish between very active (more than 5,000 MET-min-14 days), active (between 3,000 and 4,999), moderately active (between 1,250 and 2,999), and sedentary (less than 1,250). | ClinicalTrials.gov |
| Secondary | Longitudinal changes in quality of life | Baseline, 12-month, 5-year | Quality of life is measured through the World Health Organization Quality of Life (WHOQOL)-BREF. The WHOQOL-BREF comprises 26 items, categorized into four domains: physical health (7 items), psychological well-being (6 items), social connections (3 items), and environmental health (8 items) (PMID: 15085902). Additionally, it includes items addressing the overall quality of life and general health. Each item in the WHOQOL-BREF is assessed on a five-point ordinal scale. These scores are then linearly transformed to a 0-100 scale. The physical health domain encompasses aspects such as mobility, daily activities, functional capacity, energy, pain, and sleep. Within the psychological domain, assessments cover self-image, negative thoughts, positive attitudes, self-esteem, mentality, learning ability, memory concentration, religion, and mental status. The social relationships domain explores personal relationships, social support, and aspects of one's sex life. | ClinicalTrials.gov |
| Secondary | Longitudinal changes in physical fitness - Senior Fitness Test | Baseline, 12-month, 5-year | Physical fitness will be assessed using the Senior Fitness Test (SFT), a standardized battery that evaluates overall physical fitness in older adults, including muscle strength, aerobic endurance, flexibility, agility, and dynamic balance. Higher scores in the SFT indicate better physical fitness. | ClinicalTrials.gov |
| Secondary | Longitudinal changes in physical fitness - Grip Strength Test | Baseline, 12-month, 5-year | Physical Fitness will be assessed with the Grip Strength Test. For this test, the best result from 3 trials for each hand will be recorded and summed. | ClinicalTrials.gov |
| Secondary | Longitudinal Changes in Plasma Alzheimer's Disease Biomarkers and Neuroimaging Measures | Baseline, 12-month, 5-year | Change and trajectory in plasma AD biomarkers and neuroimaging measures of brain structure and function. Specifically, plasma AD biomarkers include the concentration levels of phosphorylated tau (p-tau217 and p-tau181), neurofilament light chain (NfL), and glial fibrillary acidic protein (GFAP), all expressed in pg/mL, as well as the amyloid-β 42/40 ratio. Simultaneously, neuroimaging markers derived from structural MRI include hippocampal, lateral ventricular volumes, and White Matter Hyperintensities (WMH) - all normalized to total intracranial volume (TIV)-, and a composite measure of cortical thickness in "AD-signature" regions (PMID: 21490323). | ClinicalTrials.gov |
| Secondary | Economic Outcomes: Long-term Cost-Effectiveness and Cost-Utility | Baseline, 12 months, and approximately 5 years after completion of the original PENSA intervention | Incremental cost-effectiveness ratios (ICERs) expressed as cost per unit improvement in global cognitive performance (PACC-exe), and the Incremental Cost-Utility Ratio (ICUR), expressed as the cost per Quality-Adjusted Life Year (QALY) gained based on EQ-5D-5L data. | ClinicalTrials.gov |
| Other | Longer-term Clinical Outcomes and Healthcare Utilization Using EHRs (up to 10 years of follow-up) | Baseline and within 10 years forward based on EHR | Incidence of all-cause dementia and AD identified via validated Electronic Health Record (EHR) algorithms. Time-to-event methods will be used where feasible to analyze longer-term incidence outcomes. Kaplan-Meier curves and Cox proportional hazards models, or alternative parametric/survival models if proportional hazards assumptions are not met, will be used to compare intervention groups with adjustment for baseline covariates. If event dates are not sufficiently precise or follow-up intervals are irregular, discrete-time survival models or regression models for cumulative incidence may be used instead. Longer-term healthcare utilization will be summarized descriptively and analyzed using count models (e.g., Poisson or negative binomial regression) or generalized estimating equations, as appropriate to the distribution of the data. | ClinicalTrials.gov |
| Other | Spillover Effect on study partners - Mediterranean diet adherence | Approximately 5 years after termination of PENSA | Concordance between participants and their study partners regarding Mediterranean diet adherence, measured through the Mediterranean Diet Adherence Screener (MEDAS-14). | ClinicalTrials.gov |
| Other | Spillover effect on study partners - physical activity levels | Approximately 5 years after termination of PENSA | Concordance between participants and their study partners regarding physical activity adherence, measured through the Short Minnesota Leisure Time Activities Questionnaire (VREM). | ClinicalTrials.gov |
| Other | Spillover Effect on study partners - cognitive engagement | Approximately 5 years after termination of PENSA. | Concordance between participants and their study partners regarding cognitive engagement, which is measured through the Lifestyle Activities Questionnaire (LAQ). Cognitive and social activity will be measured using a questionnaire that results from the translation and adaptation of the LAQ. The LAQ is used to assess a participant's engagement in various daily activities with different cognitive demands, such as reading, playing musical instruments, or attending social gatherings. This questionnaire allows the quantification of both the frequency and the variety of these activities. A greater variety of participation in activities, as assessed by LAQ, was associated with reduced cognitive impairment (PMCID: PMC3508669). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 14
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 15085902 | BACKGROUND | PubMed |
| 21490323 | BACKGROUND | PubMed |
| 22172155 | BACKGROUND | PubMed |
| 23223762 | BACKGROUND | PubMed |
| 25771249 | BACKGROUND | PubMed |
| 26302801 | BACKGROUND | PubMed |
| 33816762 | BACKGROUND | PubMed |
| 34966270 | BACKGROUND | PubMed |
| 36895446 | BACKGROUND | PubMed |
| 37874092 | BACKGROUND | PubMed |
| 39096926 | BACKGROUND | PubMed |
| 40551205 | BACKGROUND | PubMed |
| 40664536 | BACKGROUND | PubMed |
| 41017958 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Selective Reminding Task | Primary outcome | ConductCognition |
| Short Story Recall | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)