In an exploratory trial we enrolled 94 outpatients, aged 50 years or above (mean age
67.4 years), suffering from mild to moderate Alzheimer's disease with neuropsychiatric
features. To be eligible, patients had to fulfil the NINCDS/ADRDA diagnostic criteria
for probable Alzheimer's disease, score below 36 on the TE4D, a brief screening test
for dementia, below 6 on the Clock-Drawing Test (Sunderland scoring) and between 9
and 23 on the Syndrome Kurz-Test, a cross-culturally validated cognitive test battery.
Their total score on the 12-item Neuropsychiatric Inventory had to be at least 5,
with at least one item other than delusions or hallucinations rated 3 or higher. Patients
were randomly assigned to receive Ginkgobiloba-extract EGb 761® (240mg per day), donepezil (5mg per day during a 4-week titration
period, then 10mg per day) or EGb 761® and donepezil combined (at the same daily doses)
for a period of 22 weeks. A double-dummy technique ensured double-blind treatment
conditions. At week 22, changes from baseline and response rates were similar for
all three treatment groups with respect to all outcome measures (Syndrome Kurz-Test,
total score and distress score of the Neuropsychiatric Inventory, total score and
activitiesof-daily-living subscore of the Gottfries-Bråne-Steen Scale, Hamilton Rating
Scale for Depression, Clock-Drawing Test, Verbal Fluency Test, Concomitant Symptoms
Scale for dizziness and tinnitus).
An apparent tendency in favour of combination treatment warrants further scrutiny.
