L‑serine supplementation and lifestyle factors for brain ageing in older adults with late‑life depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Older adults with late‑life depression will be randomly assigned to receive either 6 g/day of L‑serine or a matched placebo (maltodextrin) for 48 weeks, with assessments at baseline and two follow‑up visits. Outcomes include depressive symptom scales, cognitive testing, and measures of neural function alongside neurophysiological, metagenomic, and biochemical biomarkers. The protocol excludes people with dementia, recent antibiotic or anti‑inflammatory use, active gastrointestinal disease, significant renal dysfunction, severe chronic illnesses, recent major surgery, or current substance abuse. The trial aims to link clinical changes with underlying biological mechanisms to understand how L‑serine might influence ageing‑related cognitive decline.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 65-85 years;
* Presence of depressive symptoms, defined as a score ≥ 5 on the Geriatric Depression Scale-15 items (GDS-15) or ≥ 5 on the Patient Health Questionnaire-9 (PHQ-9).

Exclusion Criteria:

* Diagnosis of dementia;
* Use of antibiotics or anti-inflammatory medications within the previous 8 weeks;
* Active gastrointestinal disease;
* Severe chronic medical conditions (e.g., advanced-stage cancer, severe cardiac or renal disorders, or other debilitating diseases);
* Renal dysfunction;
* Current alcohol or substance abuse;
* Major surgical procedures within the previous 6 months.

Where it's running

• IRCCS Centro San Giovanni di Dio Fatebenefratelli
  Brescia, Italy Recruiting

Study contacts

• Study coordinator: Moira Marizzoni, PhD
• Email: mmarizzoni@fatebenefratelli.eu
• Phone: (+39) 030 35 01 563

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.