Lifestyle changes to prevent memory problems in older adults with depression
Official title: Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice
Run by IRCCS Centro San Giovanni di Dio Fatebenefratelli · NCT07009223 · Data updated 2026-11-12
This trial will test whether a Mediterranean-style diet, regular supervised exercise, or weekly cognitive training can help prevent memory decline and improve mood in people aged 50–80 with depressive symptoms or major depression but no cognitive impairment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years to 80 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli Academic / other |
| Locations | 1 site (Brescia) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | August 2026 |
| Study ends | March 2028 |
| Registry record updated | February 11, 2026 |
| Trial ID | NCT07009223 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 50–80 years old with a DSM-5 diagnosis of major depressive disorder or measurable depressive symptoms (PHQ-9 or GDS-15 ≥ 5), who can provide informed consent and have no cognitive impairment.
✕Probably not a fit
People with diagnosed dementia, existing cognitive impairment, active gastrointestinal, autoimmune, or chronic inflammatory disorders, or recent use of antibiotics or anti-inflammatory drugs are excluded or unlikely to benefit from the interventions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study enrolls adults aged 50–80 with major depressive disorder or depressive symptoms but without signs of cognitive decline and randomizes them to one of three lifestyle interventions: online Mediterranean diet education, supervised regular physical activity, or weekly cognitive training. Participants undergo behavioral programs plus scheduled clinical and cognitive testing, and provide blood and stool samples for inflammatory markers, metabolome analysis, and gut microbiota profiling. Investigators will compare mood and cognitive outcomes across the three groups and link clinical changes to biological measures to explore underlying mechanisms. Some sessions are delivered online while exercise supervision and biological sampling require in-person visits at the coordinating center.
Why it matters
Potential benefit: If successful, these accessible lifestyle approaches could reduce depressive symptoms, slow or prevent cognitive decline, and improve daily functioning and quality of life.
How similar studies have gone: Prior trials show that exercise, Mediterranean-style diets, and cognitive training can each benefit mood or cognition, but combined mechanistic studies linking these interventions to gut microbiota and inflammation remain relatively uncommon.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, Italy Recruiting
Study contacts
- Study coordinator: Elisa Mombelli
- Email: emombelli@fatebenefratelli.eu
- Phone: (+39) 030 35 01 598
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.