Randomised, double-blind, placebo-controlled, parallel group trial to confirm the efficacy, safety and tolerability of Ginkgo biloba Special Extract EGb 761® in patients suffering from Mild Mental Impairment (MMI) - NA

Dr. Willmar Schwabe GmbH & Co. KG0 sites300 target enrollmentMarch 14, 2006

Overview

No summary available.

Registry

who.int

Start Date

March 14, 2006

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Patients are eligible for inclusion in this study, if they fulfil all of the following criteria:
•1\. Male or female outpatients aged 45 to 65 years (both inclusive)
•2\. Suffering from mild mental impairment as defined by the diagnostic criteria outlined under section 8\.7 in clinical trial protocol:
•a)subjective complaints of impairment – perceived as a decline from former level of functioning – in at least one of the following cognitive functions: memory, attention/concentration, speed of functioning, efforts required to complete complex tasks, general performance/efficiency
•b)presence of at least one of the following neuropsychiatric symptoms: depressed mood/dysphoria, anxiety, irritability/lability, apathy/indifference, fatigue, decreased general wellbeing
•c)perceived impairment present for at least 3 months
•d)widely preserved general cognitive functioning, as evidenced by a total score above 23 in the MMSE
•e)intact activities of daily living, as evidenced by inquiry (subtle difficulties, in particular slowing or increased efforts, in complex tasks is acceptable)
•f)no indication of dementia
•3\. Written informed consent according to applicable law

•Patients with any of the following characteristics must not be included in the study:
•1\. Participation in another experimental drug trial at the same time or within the past 4 weeks before enrolment
•2\. Prior participation in a clinical trial with Ginkgo biloba within the last 3 months
•3\. Hospitalization of the patient
•4\. Ischaemic stroke with sequelae within the last 3 months
•5\. Cognitive impairment due to systemic or cerebral infection, somatic disorders, neurological disorders (e.g. dementia of any type, alcohol\-associated brain damage, HIV\-associated cognitive disorder, Parkinson’s disease, Huntington’s disease, Pick’s disease, Wilson’s disease, normal pressure hydrocephalus, progressive supranuclear palsy, Creutzfeldt\-Jakob disease, brain tumour, subdural haematoma, multiple sclerosis, seizure disorder, brain trauma, etc) or psychiatric disorder (e.g. affective or anxiety disorder on a syndromal level), including clinical suspicion of any of the above.
•6\. History of recurrent major depression or recurrent anxiety disorder. If a single episode of such a disorder was present before, it must have been finished at least one year before enrolment.
•7\. D\-S’ item score for item 11 (suicidal ideation) \> 0
•8\. History of head trauma that might be causally related to cognitive impairment because of:
•\- its clinical severity or