Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
20
Countries
1
Sites
1
Under threshold depression of the elderly.
The primary objective of the study is to evaluate the efficacy of choline alfoscerate on subthreshold depression in elderly patients.
Key facts
- Sponsor
- Azienda Socio Sanitaria Territoriale Di Lodi
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 17 May 2024 → ongoing
- Decision date (initial)
- 2025-01-31
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Italfarmaco S.p.A.
External identifiers
- EU CT number
- 2025-520899-25-00
- EudraCT number
- 2021-003437-10
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Pharmacodynamic, Therapy
The primary objective of the study is to evaluate the efficacy of choline alfoscerate on subthreshold depression in elderly patients.
Secondary objectives 1
- The secondary objectives of the study are: 1. To evaluate whether choline alfoscerate can determine a specific improvement on the cognitive symptoms associated with subthreshold depression. 2. To evaluate whether choline alfoscerate can lead to a specific improvement in apathy associated with subthreshold depression.
Conditions and MedDRA coding
Under threshold depression of the elderly.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10012378 | Depression | 100000004873 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Age = 65 years 2. From 2 to 4 depressive symptoms present for at least two weeks prior to enrollment (Judd et al., 1994) 3. Mini-Mental State Examination (MMSE) score = 24 4. Montreal Cognitive Assessment (MOCA) score < 26 5. Patients able to understand and sign informed consent 6. Informed consent signature
Exclusion criteria 1
- 1. Any contraindication to treatment or intolerance to choline alfoscerate 2. Diagnosis of Major Depressive Episode or Dysthymia 3. Diagnosis of Schizophrenia or other psychotic disorders, Bipolar Disorder or Dementia 4. Alcohol / drug / substance abuse or dependence 5. Severe organic disease (eg major surgery, metastatic cancer, stroke, severe neurological disorder, myocardial infarction, chronic heart failure) 6. Treatment with antidepressants or psychotherapy within 2 weeks prior to recruitment 7. Any condition which, in the opinion of the investigator, might put the patient at risk by participation in this study 8. Patients involved in other clinical trials
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary objective will be evaluated through the analysis of the changes at the final visit from the baseline of the following tests: HAMD-17 (Hamilton Depression Rating Scale-17 items).
Secondary endpoints 1
- • The depression symptoms associated with subthreshold depression will be evaluated through the analysis of the changes at the final visit from baseline of the following tests: GDS-15 (Geriatric Depression Scale-15 items); CGI-s (Clinical Global Impression-severity). • The cognitive symptoms associated with subthreshold depression will be evaluated through the analysis of the changes at the final visit from baseline of the following tests: MOCA (Montreal Cognitive Assessment) scale.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD558441 · Product
- Active substance
- Choline Alfoscerate
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL USE
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 76800 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- N07AX02 — CHOLINE ALFOSCERATE
- Marketing authorisation
- 025937032
- MA holder
- ITALFARMACO S.P.A
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Azienda Socio Sanitaria Territoriale Di Lodi
- Sponsor organisation
- Azienda Socio Sanitaria Territoriale Di Lodi
- Address
- Piazza Ospitale 10
- City
- Lodi
- Postcode
- 26900
- Country
- Italy
Scientific contact point
- Organisation
- Azienda Socio Sanitaria Territoriale Di Lodi
- Contact name
- Dr. Giancarlo Cerveri
Public contact point
- Organisation
- Azienda Socio Sanitaria Territoriale Di Lodi
- Contact name
- Dr. Giancarlo Cerveri
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2024-05-17 | 2024-05-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol_2025-520899-25-00 TC | 2.1 |
| Protocol (for publication) | D1_ Protocol_EU CT number | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | n.a. |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_patients FP | 2.0 |
| Subject information and informed consent form (for publication) | L2_GP letter FP | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_ SmPC_GLIATILIN | n.a. |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2025-520899-25-00 ENG | 2.1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2025-520899-25-00 ITA CLEAN | 4.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2025-520899-25-00 ITA TC | 4.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_EU CT number | 4.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-28 | Italy | Acceptable with conditions 2025-01-30
|
2025-01-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-16 | Italy | Acceptable 2025-08-18
|
2025-08-22 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-22 | Italy | Acceptable 2025-08-18
|
2025-08-22 |