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The purpose of this study is to determine the effectiveness of EGb 761Ā® (TanakanĀ®) in Russian patients of middle age and younger, suffering from psycho-emotional symptoms added to cognitive disorders based on the improvement of FAM test (feeling-healthy, activity, mood test) score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psycho-emotional symptoms, added to cognitive disorders | Patients of middle age and younger with psycho-emotional symptoms, added to cognitive disorders. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGb761Ā® | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with increase of total medium FAM test score ā„1 after 3 months treatment | The FAM test is a questionnaire using three subscales (i.e. General health, Activity, and Mood). Scores for each subscale range from 3 to -3 (where -3 is bad and 3 is good). The total for each subscale and arithmetical mean is calculated. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of total medium FAM test score. | The FAM test is a questionnaire using three subscales (i.e. General health, Activity, and Mood). Scores for each subscale range from 3 to -3 (where -3 is bad and 3 is good). The total for each subscale and arithmetical mean is calculated. | 3 months |
| Change from baseline of short-time verbal memory |
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Inclusion Criteria:
Exclusion Criteria:
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Middle-age or younger patients with cognitive disorders and psycho-emotional symptoms (principal diagnosis).
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Russian National Research Medical University | Moscow | 117152 | Russia | |||
| First Moscow State Medical University |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C063170 | Ginkgo biloba extract |
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Investigator to assess short-time verbal memory using a set 10-words recall test. |
| 3 months |
| Change from baseline of attention | Attention assessed using a digit-symbol coding test. The digit symbol score is the percentage of correct symbols completed in 90 seconds. | 3 months |
| Percentage of patients who answered "Completely satisfied", "Rather satisfied", "Neither satisfied nor dissatisfied", "Rather dissatisfied" or "Completely dissatisfied", when assessing their satisfaction with TanakanĀ® | 3 months |
| Moscow |
| 119435 |
| Russia |