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Effect of treatment of the cholinergic precursor Choline Alfoscerate in mild cognitive dysfunction
EU CTIS ID: 2025-520685-21-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.