Mild cognitive dysfunction MedDRA version: 20.0 Level: SOC Classification code 10037175 Term: Psychiatric disorders System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: GLIATILIN - 10 FLAC.ORALI 600 MG
Product Name: GLIATILIN 600 mg flaconcini
Product Code: [n.d.]
Pharmaceutical Form: Oral solution
INN or Proposed INN: COLINA ALFOSCERATO
CAS Number: 28319
Sponsors
UNIVERSITA' DEGLI STUDI DI CAMERINO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient able to understand and sign informed consent and informed consent signed by family member/caregiver 2. Age = 65 years 3. 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 4. Sufficient education to enable the patient to read, write and communicate effectively 5. Indipendent patient in daily, family, work and / or social activities 6. Cooperative patient and able to complete all aspects of the study alone or with the help of a family member 7. Patient living with or in contact with a family member / caregiver who cooperates in the efficacy evaluation 8. MRI performed within 6 (six) months prior to enrollment 9. 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Overt Alzheimer’s disease 2. All decompensated cardiac disorders 3. Chronic renal failure 4. Severe hepatic insufficiency 5. Incorrect dysthyroidism (Level T3 different from 1,1 - 2,6 nmol/L, T4 different from 60 - 150 nmol/L) 6. Serious ongoing developmental systemic pathologies (eg. malignancies) 7. 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 8. Psychiatric disorders or mental retardation (Severe Depression, Psychosis, Dissociative Syndrome) 9. Alcohol / drug / substance abuse or dependence 10. 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 11. FrofAny contraindication to treatment or intolerance to choline alfoscerate 12. Patient involved in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 Objective: 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.;Primary end point(s): 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 MMSE scale at the final visit compared to baseline.;Timepoint(s) of evaluation of this end point: The final visit compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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.;Timepoint(s) of evaluation of this end point: End of the study compared to the baseline. | — |
Countries
Italy
Contacts
Public ContactCentro di Ricerche Cliniche, Teleme
Università degli Studi di Camerino
Outcome results
None listed