{"type":"trials","record":{"id":22263,"source_id":"clinicaltrials-gov","external_id":"NCT07497347","title":"Effects of Specific Amino Acid Supplementation and Lifestyle Factors on Brain Ageing","brief_summary":"The aim of this clinical trial is to investigate the effects of L-serine supplementation on cognitive decline and psychosocial functioning in older adults with late-life depression (LLD). The study will evaluate changes in depressive symptoms, neural and cognitive functioning, and will assess neurophysiological, metagenomic, and biochemical alterations associated with L-serine supplementation compared with placebo. The main research questions are: * Does L-serine supplementation affect cognitive function, depressive symptoms, and neural functioning in individuals with late-life depression? * What biological mechanisms may underlie the effects of L-serine on cognitive decline? Participants will be randomly assigned to one of two study arms: an intervention group (total n = 42) receiving L-serine at a dose of 6 g/day for 48 weeks, and a placebo group (total n = 42) receiving 6 g/day of maltodextrin for the same duration. All participants will be assessed at three time points: T0 (baseline, prior to trial initiation), T18 (after 18 weeks), and T48 (after 48 weeks, at the end of the trial). At each assessment, participants will: * complete clinical questionnaires and a neuropsychological assessment; * provide blood, fecal, and urine samples; * undergo electroencephalographic (EEG) recordings.","overall_status":"Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"IRCCS Centro San Giovanni di Dio Fatebenefratelli","enrollment":84,"countries":["Italy"],"start_date":"2026-03-01","completion_date":"2029-02-01","last_update_date":"2026-03-27","source_url":"https://clinicaltrials.gov/study/NCT07497347","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-24T01:17:17.508821+00:00","last_seen_at":"2026-09-25T06:10:45.89+00:00","metadata":{"sex":"ALL","acronym":"AAAgeing","age_range":"65 Years to 85 Years","comparator":"Placebo group","organization":"IRCCS Centro San Giovanni di Dio Fatebenefratelli","interventions":["L-serine supplementation","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Geriatric Depression Scale - 15 — Baseline; week 18; week 48 (end of the trial)","Repeatable Battery for the Assessment of Neuropsychological Status — Baseline, Week 18; Week 48 (end of the trial)","Patient Health Questionnaire - 9 — Baseline; Week 18; Week 48 (end of the trial)","Montgomery-Åsberg Depression Rating Scale — Baseline, Week 18; Week 48 (end of the trial)","World Health Organization Quality of Life - Bref — Baseline, Week 18, Week 48 (end of trial)","Electroencephalogram -derived neurophysiological metrics — Baseline, Week 48 (end of the trial)","Gut Microbiome Composition — Baseline, Week 18; Week 48 (end of trial)","Immune-related biomarkers levels — Baseline; Week 18; Week 48 (end of trial)","Amino acid and metabolic biomarkers — Baseline, Week 18; Week 48 (end of trial)","Neuroendocrine and stress-related biomarkers — Baseline, Week 18; Week 48","Neurotrophic biomarkers — Baseline, Week 18; Week 48"],"design_description":"RANDOMIZED · PARALLEL · SUPPORTIVE CARE · DOUBLE","source_has_results":false},"controlled_terms":["Late-Life Depression","L-serine supplementation","Placebo"],"relevance_confidence":80,"source_quality_score":100,"freshness_score":85,"publication_state":"published","match_explanation":"Title contains controlled term: brain ageing.","quality_checked_at":"2026-09-25T06:10:48.460085+00:00","duplicate_cluster_key":"id:nct07497347","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-03-01 to 2029-02-01","comparator":"Placebo group","confidence":"structured-source","population":"ALL · 65 Years to 85 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:45.899Z","intervention":["L-serine supplementation","Placebo"],"participants":84,"study_design":"RANDOMIZED · PARALLEL · SUPPORTIVE CARE · DOUBLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Geriatric Depression Scale - 15 — Baseline; week 18; week 48 (end of the trial)","Repeatable Battery for the Assessment of Neuropsychological Status — Baseline, Week 18; Week 48 (end of the trial)","Patient Health Questionnaire - 9 — Baseline; Week 18; Week 48 (end of the trial)","Montgomery-Åsberg Depression Rating Scale — Baseline, Week 18; Week 48 (end of the trial)","World Health Organization Quality of Life - Bref — Baseline, Week 18, Week 48 (end of trial)","Electroencephalogram -derived neurophysiological metrics — Baseline, Week 48 (end of the trial)","Gut Microbiome Composition — Baseline, Week 18; Week 48 (end of trial)","Immune-related biomarkers levels — Baseline; Week 18; Week 48 (end of trial)","Amino acid and metabolic biomarkers — Baseline, Week 18; Week 48 (end of trial)","Neuroendocrine and stress-related biomarkers — Baseline, Week 18; Week 48","Neurotrophic biomarkers — Baseline, Week 18; Week 48"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"cognitive-aging","is_published":true,"match_reasons":["Title contains controlled term: brain ageing.","Title supplies longevity context: ageing.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","title context","study type"],"relevance_score":80,"intelligence_topics":{"name":"Cognitive ageing","slug":"cognitive-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/22263","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}