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NCT07730671

Overview

NCT ID: NCT07730671
Lead Sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall FoundationOTHER
Official Title: 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
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 28, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Sep 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 121Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: Natàlia Soldevila Domènech, MPH, PhDContact
nsoldevila@barcelonabeta.org

Similar Studies

Participant Group/Arms

Multimodal Lifestyle Intervention + EGCG

Participants who completed the original PENSA trial and were assigned to the intensive personalized multimodal lifestyle intervention combined with epigallocatechin gallate (EGCG) supplementation for 12 months. The intervention included dietary counseling, physical exercise, cognitive training, psychoeducation, social stimulation, and vascular risk management. Participants are followed approximately 5 years after completion of the intervention (current PENSA+ study) to evaluate long-term cognitive, biological, lifestyle, and health outcomes.

Multimodal Lifestyle Intervention + Placebo

Participants who completed the original PENSA trial and were assigned to the intensive personalized multimodal lifestyle intervention combined with placebo supplementation for 12 months. The intervention included dietary counseling, physical exercise, cognitive training, psychoeducation, social stimulation, and vascular risk management. Participants are followed approximately 5 years after completion of the intervention (current PENSA+ study) to evaluate long-term cognitive, biological, lifestyle, and health outcomes.

Control

Participants who completed the original PENSA trial and were assigned to the control group, receiving general healthy lifestyle recommendations without the intensive multimodal intervention. Participants are followed approximately 5 years after completion of the original study (current PENSA+ study) to evaluate long-term cognitive, biological, lifestyle, and health outcomes.