CHOLINE ALFOSCERATE for Mild cognitive dysfunction

Inclusion criteria

• {"criterion_text":"- Patient able to understand and sign informed consent and informed consent signed by family member/caregiver\n- Age = 65 years\n- 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\n- Sufficient education to enable the patient to read, write and communicate effectively\n- Indipendent patient in daily, family, work and / or social activities\n- Cooperative patient and able to complete all aspects of the study alone or with the help of a family member\n- Patient living with or in contact with a family member / caregiver who cooperates in the efficacy evaluation\n- MRI performed within 6 (six) months prior to enrollment\n- 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

• {"criterion_text":"- Overt Alzheimer’s disease\n- 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\n- FrofAny contraindication to treatment or intolerance to choline alfoscerate\n- Patient involved in other clinical trials\n- All decompensated cardiac disorders\n- Chronic renal failure\n- Severe hepatic insufficiency\n- Incorrect dysthyroidism (Level T3 different from 1,1 - 2,6 nmol/L, T4 different from 60 - 150 nmol/L)\n- Serious ongoing developmental systemic pathologies (eg. malignancies)\n- 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\n- Psychiatric disorders or mental retardation (Severe Depression, Psychosis, Dissociative Syndrome)\n- Alcohol / drug / substance abuse or dependence"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured using evaluation of brain atrophy, mainly of hippocampal area, studied by segmentation of images obtained by MRI."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Assessed through neuropsychological scales/tests evaluating cognitive performance (executive, memory, visual-constructive, linguistic and attentional functions); functional performance and mood/motivation changes evaluated with specific neuropsychological tests, comparing end-of-study to baseline."}

Italy

Earliest CTIS Part Ii Submission Date

21-01-2025

Latest Decision Or Authorization Date

31-01-2025

Processing Time Days

10

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Universita' Degli Studi Di Camerino

Organisation Type

Educational Institution

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Italfarmaco S.p.A.","duties_or_roles":"Source of monetary support; provider/manufacturer of GLIATILIN (marketing authorisation holder for GLIATILIN indicated in product data).","organisation_type":"Commercial/Pharmaceutical company"}