Health Condition 1: null- Patients diagnosed with dementia including Alzheimers disease vascular dementia or mixed dementia
Conditions
Interventions
Intervention1: Tebokan® forte (Ginkgo biloba leaves extract (EGb 761®): Dose 120 mg film coated tab
Frequency Twice Daily
Route of Administration Oral
Total duration of therapy
18 week
Sponsors
Dr Willmar Schwabe India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Subjects with at least 50 years of age 2 Subjects diagnosed with dementia specifically Major Neurocognitive Disorder due to Alzheimers disease Major Vascular Neurocognitive Disorder or mixed form of both in accordance with DSM 5 criteria cf section 4 1 1 3 MMSE between 12 and 24 inclusive 12 to 18 moderate dementia and 19 to 24 mild dementia 4 Presence of a caregiver 5 Subject LAR ready to give written consent to participate in the trial and ready to follow all study related procedures 6 Post menopausal female subjects or non menopausal female subjects with negative serum pregnancy test and willing to use a reliable means of contraception other than or in addition to hormonal contraceptives eg double barrier method diaphragm plus spermicide condom plus spermicide, etc surgical sterilization or abstinence for the duration of the study. 7 Subjects not participating in any other clinical trial since last 6 months
Exclusion criteria
Exclusion criteria: Subjects diagnosed with dementia except AD VD or mixed dementia Subjects currently undergoing treatment for depression Subjects with major depression or other psychiatric disorder hospitalized for depression within one year prior to baseline visit Use of Ginkgo biloba within 8 weeks prior to baseline visit Use of cholinesterase inhibitor within 6 months of baseline visit History of any bleeding abnormalities other than in the context of anti platelet or anti coagulant drugs Any other type of neurological disorder as per investigator s discretion Active malignant disease HIV or serious infection as per investigators discretion Subjects currently on cognitive enhancers cholinergic anti cholinergic or haemorheologically active drugs Severe or insufficiently controlled cardiovascular renal or hepatic disorder diabetes anaemia or thyroid dysfunction as per investigator s discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of presumed adverse drug reactions and percentage of subjects with presumed adverse drug reactions between baseline and week 18 Number of adverse events and percentage of subjects with adverse events between baseline and week 18 Number of serious adverse events and percentage of subjects with serious adverse events between baseline and week 18 Changes in the vital signs physical and laboratory examination between baseline and week 18Timepoint: baseline and week 18 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to week 18 in a picture learning test representing attention and memory CERAD constructional praxis and recall of constructional praxisTimepoint: baseline and week 18;Change from baseline to week 18 in the BEHAVE ADTimepoint: baseline and week 18;Change from baseline to week 18 in the Trail Making Test A and B representing speed and executive functioningTimepoint: baseline and week 18;Change in CGI scale from baseline to week 18Timepoint: baseline and week 18;Number and percentage of patients with improvement in cognitive functioning from baseline to week 18 for Trail Making Test and CERAD constructional praxis and recall of constructional praxis either or bothTimepoint: baseline and week 18;Number and percentage of subjects improving or recovering from vertigo and or tinnitus from baseline through week 18 via 11 Point Box Scales for vertigo and tinnitusTimepoint: baseline and week 18 | — |
Countries
India
Contacts
Public ContactRavi Kumar Manchanda
Dr. Willmar Schwabe India Pvt Ltd
Outcome results
None listed