Late-Life DepressionAAAgeingNCT07497347
Effects of Specific Amino Acid Supplementation and Lifestyle Factors on Brain Ageing
A study testing L-serine supplementation in people with Late-Life Depression, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Late-Life Depression
- What is being tested?
- L-serine supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2026to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, 25125
Annamaria Cattaneo, PhD, 0303501598, acattaneo@fatebenefratelli.eu
About this study
Official title: Translational Investigation of Specific Amino Acid Supplementation and Lifestyle Factors in Brain Ageing
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:
Read more
- 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.
- Conditions
- Late-Life Depression
- Being tested
- L-serine supplementation, Placebo
- Keywords
- Late-life depression, L-serine supplementation, Ageing- related Cognitive Decline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-serine supplementationDietary supplement
Participants randomized to the experimental arm will receive L-serine supplementation (6 g/day), administered orally as a single stick per day for a total duration of 48 weeks.
PlaceboOther
Participants randomized to the Placebo arm will receive Maltodextrine supplementation (6 g/day), administered orally as a single stick per day for a total duration of 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| L-serine group | Experimental | L-serine supplementation, 6 g/day, oral stick, 48 weeks. Receives: Dietary Supplement: L-serine supplementation |
| Placebo group | Placebo comparator | Maltodextrine supplementation, 6 g/day, oral stick, 48 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatric Depression Scale - 15
The Geriatric Depression Scale - 15 items (GDS-15) is a validated clinical instrument widely used in clinical and research settings to screen for depressive symptoms in older adults.
Measured: Baseline; week 18; week 48 (end of the trial)
Repeatable Battery for the Assessment of Neuropsychological Status
The Repeatable Battery for the Assessment of Neuropsychological (RBANS) is a neuropsychological battery composed of 12 subtests grouped into five domains: Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory. It yields index scores and a total scale score. Higher scores indicate better cognitive functioning, reflecting a more favorable clinical outcome.
Measured: Baseline, Week 18; Week 48 (end of the trial)
Patient Health Questionnaire - 9
The Patient Health Questionnaire-9 (PHQ-9) is a self-administered instrument used to assess the severity of depressive symptoms based on DSM criteria. It consists of 9 items, each rated from 0 (not at all) to 3 (nearly every day), resulting in a total score ranging from 0 to 27. Higher scores reflect more severe depressive symptoms, indicating a worse clinical outcome.
Measured: Baseline; Week 18; Week 48 (end of the trial)
Montgomery-Åsberg Depression Rating Scale
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered scale designed to assess the severity of depressive symptoms. It consists of 10 items, each rated on a scale from 0 to 6, yielding a total score ranging from 0 to 60. Higher scores indicate greater severity of depression, meaning a worse clinical outcome
Measured: Baseline, Week 18; Week 48 (end of the trial)
World Health Organization Quality of Life - Bref
The World Health Organization Quality of Life - Bref (WHOQOL-BREF) is a self-report questionnaire developed by the WHO to assess quality of life across multiple domains. It contains 26 items rated on a 5-point Likert scale. Higher scores indicate a better quality of life, reflecting a more favorable outcome.
Measured: Baseline, Week 18, Week 48 (end of trial)
Secondary outcomes (6)
Electroencephalogram -derived neurophysiological metrics
Electroencephalogram (EEG) recordings will be used to derive individual spectral analysis and connectivity.
Measured: Baseline, Week 48 (end of the trial)
Gut Microbiome Composition
Assessment of gut microbiome composition through analysis of fecal samples using high-throughput sequencing techniques (e.g., 16S rRNA gene sequencing). Microbial diversity (alpha and beta diversity) and relative abundance of bacterial taxa will be evaluated.
Measured: Baseline, Week 18; Week 48 (end of trial)
Immune-related biomarkers levels
Plasma and serum levels of immune-related biomarkers will be measured, including cytokines and chemokines, C-reactive protein (CRP), and NLRP3. Quantitative assessment will be performed using validated laboratory assays. Changes in biomarker concentrations over time will be evaluated.
Measured: Baseline; Week 18; Week 48 (end of trial)
Amino acid and metabolic biomarkers
L-serine and D-serine concentrations will be measured in blood, urine, and fecal samples using validated analytical methods. Quantitative assessment of biomarker levels and changes over time will be performed.
Measured: Baseline, Week 18; Week 48 (end of trial)
Neuroendocrine and stress-related biomarkers
Cortisol levels will be measured in blood samples and corticosterone levels in fecal samples using validated analytical methods. Quantitative assessment of biomarker concentrations and changes over time will be performed.
Measured: Baseline, Week 18; Week 48
Neurotrophic biomarkers
Changes in brain-derived neurotrophic factor (BDNF) levels will be measured in blood samples
Measured: Baseline, Week 18; Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late-Life DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm randomized controlled design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497347
- Sponsor's protocol ID
- CERP-2024-23685719
- Acronym
- AAAgeing
- Status last verified
- Mar 2026
- First submitted
- 9 Feb 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Investigation of Specific Amino Acid Supplementation and Lifestyle Factors in Brain Ageing
- ClinicalTrials.gov ID
- NCT07497347
- Acronym / sponsor ID
- AAAgeing / CERP-2024-23685719
- Conditions
- Late-Life Depression
- Keywords
- Late-life depression, L-serine supplementation, Ageing- related Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| L-serine group | Experimental | Dietary Supplement: L-serine supplementationL-serine supplementation, 6 g/day, oral stick, 48 weeks. |
| Placebo group | Placebo comparator | Other: PlaceboMaltodextrine supplementation, 6 g/day, oral stick, 48 weeks. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-serine supplementationParticipants randomized to the experimental arm will receive L-serine supplementation (6 g/day), administered orally as a single stick per day for a total duration of 48 weeks. | Dietary supplement | L-serine group |
| PlaceboParticipants randomized to the Placebo arm will receive Maltodextrine supplementation (6 g/day), administered orally as a single stick per day for a total duration of 48 weeks. | Other | Placebo group |
Primary outcome
Geriatric Depression Scale - 15
Time frame: Baseline; week 18; week 48 (end of the trial)
The Geriatric Depression Scale - 15 items (GDS-15) is a validated clinical instrument widely used in clinical and research settings to screen for depressive symptoms in older adults.
Repeatable Battery for the Assessment of Neuropsychological Status
Time frame: Baseline, Week 18; Week 48 (end of the trial)
The Repeatable Battery for the Assessment of Neuropsychological (RBANS) is a neuropsychological battery composed of 12 subtests grouped into five domains: Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory. It yields index scores and a total scale score. Higher scores indicate better cognitive functioning, reflecting a more favorable clinical outcome.
Patient Health Questionnaire - 9
Time frame: Baseline; Week 18; Week 48 (end of the trial)
The Patient Health Questionnaire-9 (PHQ-9) is a self-administered instrument used to assess the severity of depressive symptoms based on DSM criteria. It consists of 9 items, each rated from 0 (not at all) to 3 (nearly every day), resulting in a total score ranging from 0 to 27. Higher scores reflect more severe depressive symptoms, indicating a worse clinical outcome.
Montgomery-Åsberg Depression Rating Scale
Time frame: Baseline, Week 18; Week 48 (end of the trial)
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered scale designed to assess the severity of depressive symptoms. It consists of 10 items, each rated on a scale from 0 to 6, yielding a total score ranging from 0 to 60. Higher scores indicate greater severity of depression, meaning a worse clinical outcome
World Health Organization Quality of Life - Bref
Time frame: Baseline, Week 18, Week 48 (end of trial)
The World Health Organization Quality of Life - Bref (WHOQOL-BREF) is a self-report questionnaire developed by the WHO to assess quality of life across multiple domains. It contains 26 items rated on a 5-point Likert scale. Higher scores indicate a better quality of life, reflecting a more favorable outcome.
6 secondary outcomes
Electroencephalogram -derived neurophysiological metrics
Time frame: Baseline, Week 48 (end of the trial)
Gut Microbiome Composition
Time frame: Baseline, Week 18; Week 48 (end of trial)
Immune-related biomarkers levels
Time frame: Baseline; Week 18; Week 48 (end of trial)
Amino acid and metabolic biomarkers
Time frame: Baseline, Week 18; Week 48 (end of trial)
Neuroendocrine and stress-related biomarkers
Time frame: Baseline, Week 18; Week 48
Neurotrophic biomarkers
Time frame: Baseline, Week 18; Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-serine supplementation in people with Late-Life Depression, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moira Marizzoni, PhD ((+39) 030 35 01 563, mmarizzoni@fatebenefratelli.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geriatric Depression Scale - 15 (time frame: Baseline; week 18; week 48 (end of the trial)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.