E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild cognitive impairment |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009846 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the efficacy of Cavinton Forte tablets administered for 18 months in patients with MCI. |
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E.2.2 | Secondary objectives of the trial |
To investigate the long term safety and tolerability of the study medication. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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piracetam, nicergolin, pyritinol, metylphenidate, Gingko Biloba extracts) with patients unable or unwilling to be withdrawn from this medication before the trial.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.
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E.5 End points |
E.5.1 | Primary end point(s) |
The analysis of ADAS-Cog scale will be performed on the difference from baseline data using repeated measures ANOVA. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the study is when the last subject completed the last visit (Visit 6). |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |