Multicenter, open-label study to investigate the efficacy and safety of Cavinton Forte (vinpocetine) tablet in patients with mild cognitive impairment (MCI).

• Conditions: Mild cognitive impairment; MedDRA version: 9.1Level: LLTClassification code 10009846

• Registration Number: EUCTR2006-005841-13-HU
• Lead Sponsor: Gedeon Richter Plc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Meet the diagnostic criteria of MCI (Mayo criteria)
•Total score of MMSE is between 24-28.
•Age between 35 and 70 years (both males and females).
•18 kg/m2 = BMI = 35 kg/m2 (and the minimal body weight is 40 kg)
•Education level is min. 6 classes.
•Signed Inform Consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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

Exclusion Criteria

•Severe vascular disease (for example: territorial stroke, TIA, clinically significant (>70%) carotis stenosis or occlusion) in medical history.
•Severe dementia.
•Uncontrolled hypertension (systolic > 180 Hgmm, diastolic > 110 Hgmm).
•If QTc > 500 msec.
•Any clinically significant abnormality in clinical laboratory tests. Screening haematology and biochemistry laboratory tests must be within defined limits including full blood count within the normal range (or not clinically significantly abnormal), liver enzymes not exceed three times the upper limit of normal range, alkaline phosphatase, bilirubin not exceed twice the upper limit of normal range.
•Having received the investigational product (vinpocetine) during 1 month prior to the study. (In this case patient can be involved into the study after 1 month long wash-out period.)
•Current treatment with drugs having cognitive effect in the central nervous system (for example: piracetam, nicergolin, pyritinol, metylphenidate, Gingko Biloba extracts) with patients unable or unwilling to be withdrawn from this medication before the trial.
•A history of drug or alcohol abuse within the past 2 years or current chronic or intermittent users of illicit drugs.
•Known hypersensitivity to vinpocetine or lactose intolerance.
•Severe physical or mental concomitant disorder that might confound the conduct or result of the trial.
•Depression (total score of Hamilton Depression Scale is more than 12).
•Lactating or pregnant women or women of child-bearing potential without appropriate contraceptive treatment.
•Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study or to cooperate on the necessary level.
•Evidence of an uncooperative attitude.
•Patients who have participated in a study of an investigational drug or device within 3 months of this study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the efficacy of Cavinton Forte tablets administered for 18 months in patients with MCI.;Secondary Objective: To investigate the long term safety and tolerability of the study medication.;Primary end point(s): The analysis of ADAS-Cog scale will be performed on the difference from baseline data using repeated measures ANOVA.