NCT07009223 Lifestyle Interventions to Prevent Cognitive Deficits in Subjects With Depressive Symptoms: From Mechanisms to Clinical Practice
| NCT ID | NCT07009223 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli |
| Condition | Major Depressive Disorder (MDD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-10-01 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical study is to investigate if lifestyle changes can help prevent cognitive decline and reduce depressive symptoms in people between the ages of 50 and 80 with depressive symptoms or a diagnosis of major depression, but without signs of cognitive decline. The main questions it aims to answer are: * Does regular physical activity improve mood and memory in people who are depressed or have depressive symptoms? * Does cognitive training help prevent mental difficulties in people at risk of cognitive decline? * Do changes in diet and lifestyle alter the composition of the gut microbiota and immuno-related infiammatory factors? Researchers will compare three different treatment groups to see which intervention is most effective in improving mental and cognitive health. The participants: * Will take part to online sessions on healthy eating based on the Mediterranean diet * Some will do regular exercise, supervised by a personal trainer * Others will do weekly cognitive training in small groups at the hospital * They will provide blood and fecal samples and complete cognitive tests and clinical questionnaires at the beginning, at the end of the treatment (12 weeks), and after 3 months.
Eligibility Criteria
Inclusion Criteria: * Aged between 50 and 80 years; * Diagnosis of DDM according to DSM-5 or depressive symptoms (PHQ-9 or GDS-15 ≥ 5, the choice of test will be justified by the participant's age); * Ability to provide written informed consent. Exclusion Criteria: * Active gastrointestinal disorders; * Autoimmune disorders; * Chronic inflammatory disorders; * Diagnosis of dementia; cognitive impairment or mild functional impairment. * Use of antibiotics and/or anti-inflammatory drugs in the 8 weeks prior to the screening visit.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07009223 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Major Depressive Disorder (MDD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07009223 currently recruiting?
Yes, NCT07009223 is actively recruiting participants. Contact the research team at emombelli@fatebenefratelli.eu for enrollment information.
Where is the NCT07009223 trial being conducted?
This trial is being conducted at Brescia, Italy.
Who is sponsoring the NCT07009223 clinical trial?
NCT07009223 is sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli. The trial plans to enroll 120 participants.