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P4‐339: MRI evidence for a disease‐modifying effect of Ginkgo Biloba extract in a dementia prevention trial
Author(s) -
Kaye Jeffrey A.,
Dodge Hiroko,
Zitzelberger Tracy,
Moore Milar,
Oken Barry
Publication year - 2008
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2008.05.2409
Subject(s) - placebo , medicine , context (archaeology) , dementia , randomized controlled trial , ginkgo biloba , brain size , asymptomatic , magnetic resonance imaging , anesthesia , disease , pathology , radiology , pharmacology , paleontology , alternative medicine , biology
Background: Decreased rates of brain volume loss are proposed as measures of “disease modifying” effects in dementia clinical trials. For dementia prevention studies, this method may be particularly important for demonstrating effects on the brain when asymptomatic. In this context we assessed whether Ginkgo Biloba extract (GBE) had an affect on rate of brain volume loss in normal elderly aged 85 and older followed in a randomized controlled trial (RCT) of dementia prevention. Methods: As part of a randomized, placebocontrolled, double-blind, 42-month study with 118 cognitively intact subjects (CDR 0) randomized to standardized GBE or placebo each subject was scanned at baseline and then during annual follow-up exams using the same 1.5 T MRI equipment. Standard volumetric MRI image analysis procedures were used to assess the volumes of total brain, ventricular volume, white matter high signal (WMH) and hippocampus. Univariate analysis compared the yearly rates of volume change between the GBE and placebo groups. A mixed effects model of the changes in each brain volume over time was used to compare differences between the two groups, adjusting for the specific baseline brain volumes, baseline intracranial volume, sex, apoE genotype, and medication adherence. Results: There was a significantly (p 0.02) lower rate of total brain volume loss in the GBE group (-0.9 1.1%/year) vs. the placebo group (-1.5 1.2%/year). The mixed model showed a significantly faster total brain loss among the placebo group (p 0.02), compared with the GBE group. There was no significant difference between the GBE and placebo treated groups in the rate of change in ventricular, WMHS or hippocampal volumes. Conclusions: GBE treatment reduced the rate of brain lost in healthy seniors. This supports the clinical efficacy data adjusted for medication adherence, shown in our previous study (Neurology, 70(9), 2008). These results suggest a “disease-modifying” effect in a RCT prevention study. Larger prevention trials with greater statistical power to observe these effects are needed to confirm these observations.