L‑serine supplementation and lifestyle factors for brain ageing in older adults with late‑life depression
Translational Investigation of Specific Amino Acid Supplementation and Lifestyle Factors in Brain Ageing
This trial tests whether taking L‑serine daily for 48 weeks helps thinking, mood, and brain function in people aged 65–85 with late‑life depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli Academic / other |
| Locations | 1 site (Brescia) |
| Trial ID | NCT07497347 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65–85 with depressive symptoms (GDS‑15 ≥5 or PHQ‑9 ≥5) who do not have dementia and do not have recent antibiotic/anti‑inflammatory use, active gastrointestinal disease, significant renal dysfunction, severe chronic medical conditions, recent major surgery, or current substance abuse.
Not a fit: People with diagnosed dementia, significant renal impairment, active gastrointestinal disease, recent antibiotic or anti‑inflammatory use, severe chronic illnesses, recent major surgery, or current substance abuse are unlikely to benefit or be eligible for this protocol.
Why it matters
Potential benefit: If successful, L‑serine supplementation could slow cognitive decline and improve depressive symptoms and brain function in older adults with late‑life depression.
How similar studies have performed: This approach is relatively novel: some preclinical work and small human studies suggest L‑serine can affect neural function, but large placebo‑controlled trials in late‑life depression are lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Brescia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.