Comparison of choline alphoscerate and citicoline in elderly patients with cognitive disorders of vascular origi

Phase 1

• Conditions: Cognitive impairment resulting from cerebrovascular event.; MedDRA version: 21.1Level: LLTClassification code 10000374Term: Accident cerebrovascularSystem Organ Class: 100000004852; MedDRA version: 21.1Level: LLTClassification code 10009846Term: Cognitive impairmentSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-000762-29-IT
• Lead Sponsor: MDM S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-20
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

•Adults male and female aged = 65 years.
•Patients with mild cognitive impairment (MMSE 21-26) post-TIA/stroke
•Subject available for the whole study period and written informed consent obtained prior to enrollement in the study.
•Females infertile according to the following criteria:
•menopausae (amenorrhea of 12 months or more after the conclusion of all the exogenous hormone treatments
•irreversible surgical sterilization documentation (hysterectomy or oophorectomy or bilateral salpingectomy but no tubal ligation).

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 64

Exclusion Criteria

•Patients with cognitive impairment due to other condition
•Moderate-severe cognitive impairment (MMSE 10-20 or <10)
•Unable to read and/or write
•Evidence of severe or uncontrolled systemic disease or any other significant disorders, which in the opinion of the investigator does not allow the participation in the study or could compromise patient compliance.
•Hypersensitivity to study drugs or excipients.
•History of alcohol or drug abuse.
•Enrollment in another study protocol within 30 days prior to randomization.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of efficacy of the administration of choline alfoscerate injection compared to citicoline injection on global cognitive function.;Secondary Objective: -Evaluation of efficacy of the administration of choline alfoscerate injection compared to citicoline injection on specific cognitive functions, depression, daily living activity and motor impairment.<br>-Safety profile of the two study drugs.<br>;Primary end point(s): Global cognitive functions assessment: <br>•Mini Mental State Examination (MMSE) <br>•Montreal Cognitive Assessment (MoCA)<br>;Timepoint(s) of evaluation of this end point: At baseline and after treatment with one of the study drugs for 30 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Specific cognitive functions assessment: <br>¿Rey¿s 15 Words Test <br>¿Verbal memory span <br>¿ Frontal Assessment Battery (FAB) ; -Depression assessment: <br>¿Hamilton Psychiatric Rating scale for Depression (HAMD) <br>¿ Beck Depression Inventory (BDI); -Daily Living assessment: <br>¿Activities of Daily Living (ADL) <br>¿Instrumental Activities of Daily Living (IADL); -Motor impairment assessment <br>¿ Barthel Index <br>¿Physical Performance Test <br>¿Medical Research Council Scale for muscle strength ; -Adverse events occurrence.;Timepoint(s) of evaluation of this end point: At baseline and after treatment with one of the study drugs for 30 days; At baseline and after treatment with one of the study drugs for 30 days<br>; At baseline and after treatment with one of the study drugs for 30 days; At baseline and after treatment with one of the study drugs for 30 days; Throughout the study