Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
60
Countries
1
Sites
1
Mild cognitive dysfunction
The study intends to evaluate the slowing and / or stability of hippocampal atrophy, entorhinal cortex, neocortex and ventricular dilation through the use of a cholinergic precursor (choline alfoscerate) in patients with mild cognitive dysfunction with associated vascular damage.
Key facts
- Sponsor
- Universita' Degli Studi Di Camerino
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- 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
- 2025-520685-21-00
- EudraCT number
- 2020-000576-38
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Safety
The study intends to evaluate the slowing and / or stability of hippocampal atrophy, entorhinal cortex, neocortex and ventricular dilation through the use of a cholinergic precursor (choline alfoscerate) in patients with mild cognitive dysfunction with associated vascular damage.
Secondary objectives 1
- The study intends to evaluate whether the effectiveness of the cholinergic precursor Choline Alfoscerate is superior to that of placebo in the stability and / or improvement of cognitive abilities. Functional performances and changes in mood and motivation will also be monitored. Safety and tolerability of the study drug will be.
Conditions and MedDRA coding
Mild cognitive dysfunction
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10037175 | Psychiatric disorders | 7 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Patient able to understand and sign informed consent and informed consent signed by family member/caregiver
- Age = 65 years
- Memory disorders presence evaluated by Neuropsychological Testing (see below): • Mini Mental State Evaluation (MMSE, Folstein et al 1975): score= 24 • Clinical Dementia Rating (CDR) = 0,5
- Sufficient education to enable the patient to read, write and communicate effectively
- Indipendent patient in daily, family, work and / or social activities
- Cooperative patient and able to complete all aspects of the study alone or with the help of a family member
- Patient living with or in contact with a family member / caregiver who cooperates in the efficacy evaluation
- MRI performed within 6 (six) months prior to enrollment
- Presence of at least 2 (two) vascular risk factors listed below: ¿ systemic arterial hypertension ¿ diabetes mellitus ¿ obesity ¿ heart disease (e.g. atrial fibrillation) ¿ dyslipidaemia ¿ hyperhomocysteinemia ¿ tobacco addiction ¿ previous cerebrovascular events ¿ family history of cardio-cerebrovascular diseases
Exclusion criteria 12
- Overt Alzheimer’s disease
- All decompensated cardiac disorders
- Chronic renal failure
- Severe hepatic insufficiency
- Incorrect dysthyroidism (Level T3 different from 1,1 - 2,6 nmol/L, T4 different from 60 - 150 nmol/L)
- Serious ongoing developmental systemic pathologies (eg. malignancies)
- Any advanced, progressive or unstable disease that, in the opinion of the investigator, could interfere with efficacy or safety assessments or that could put the patient at risk by participation in the study
- Psychiatric disorders or mental retardation (Severe Depression, Psychosis, Dissociative Syndrome)
- Alcohol / drug / substance abuse or dependence
- Diagnosis of Major Depression according to (DSM V), except in cases successfully treated with stable dose of antidepressant (non-anticholinergic) for at least 4 weeks prior to recruitment
- FrofAny contraindication to treatment or intolerance to choline alfoscerate
- Patient involved in other clinical trials
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The slowing and / or stability of hippocampal atrophy, entorhinal cortex, neocortex and ventricular dilation through the use of a cholinergic precursor (choline alfoscerate) in patients with mild cognitive dysfunction with associated vascular damage will be measured using the evaluation of the brain atrophy, mainly of hippocampal area, studied by segmentation of the images obtained by MRI.
Secondary endpoints 1
- The stability and/or improvement of cognitive abilities will be assessed through the use of neuropsychological scales that will evaluate the cognitive performance of patients (executive, memory, visual-constructive, linguistic and attentional functions) at the end of the study compared to the baseline visit. Functional performances and changes in mood and motivation will be evaluated with specific neuropsychological tests.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD558450 · Product
- Active substance
- Choline Alfoscerate
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL USE
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 438 g gram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- N07AX02 — CHOLINE ALFOSCERATE
- Marketing authorisation
- 025937044
- MA holder
- ITALFARMACO S.P.A
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universita' Degli Studi Di Camerino
- Sponsor organisation
- Universita' Degli Studi Di Camerino
- Address
- Piazza Camillo Benso Conte Di Cavour 19f
- City
- Camerino
- Postcode
- 62032
- Country
- Italy
Scientific contact point
- Organisation
- Universita' Degli Studi Di Camerino
- Contact name
- Enea Traini
Public contact point
- Organisation
- Universita' Degli Studi Di Camerino
- Contact name
- Enea Traini
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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_2025-520685-21-00 | 3.0 |
| Protocol (for publication) | D1_ Protocol_2025-520685-21-00 TC | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | na |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_patients | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_privacy | 1.0 |
| Subject information and informed consent form (for publication) | L2_GP letter | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_ SmPC_GLIATILIN | na |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2025-520685-21-00 | 3.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2025-520685-21-00 ENG | 3.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2025-520685-21-00 ITA TC | 3.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-24 | Italy | Acceptable with conditions 2025-01-30
|
2025-01-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-27 | Italy | Acceptable 2025-09-10
|
2025-09-11 |