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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520685-21-00
Enrollment
60
Registered
2025-01-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild cognitive dysfunction

Brief summary

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.

Detailed description

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.

Interventions

DRUGComposition (except active ingredient): Methylparaben Ph. Eur. Propylparaben Ph. Eur. Saccharine Sodium Ph. Eur. Orange Flavor 1111853 Purified water q.s.
DRUGGLIATILIN 600 mg flaconcini

Sponsors

Universita' Degli Studi Di Camerino
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026