Effect of treatment of the cholinergic precursor Choline Alfoscerate in mild cognitive dysfunction

Phase 4

Not yet recruiting

Conditions: Mild cognitive dysfunction

Registration Number: 2025-520685-21-00

Lead Sponsor: Universita' Degli Studi Di Camerino

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

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

Overt Alzheimer’s disease

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

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

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.		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 Outcome Measures

Name	Time	Method
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.		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.

Trial Locations

Locations (1): Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
🇮🇹
Naples, Italy
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
🇮🇹Naples, Italy
Vincenzo Andreone
Site contact
0817471111
vincenzo.andreone@aocardarelli.it