Effects of Botanicals on Cognition in Midlife Women
Principal Investigator: Pauline Maki
Abstract: The broad, long-term objective of this program of research is to better understand the effects of hormone therapy (HT) and alternative botanical supplements on cognition and brain functioning in early postmenopausal women. The specific aims of this research project are to quantify and compare the effects of the botanical menopausal treatments, black cohosh and red clover, and standard HT, Prempro (r) (conjugated equine estrogen plus medroxyprogesterone acetate), on neuropsychological and neuroimaging outcomes. The proposed design is a randomized, double-blind, placebo-controlled clinical trial. The cognitive study is conducted as an ancillary study to the NIH-funded study, A Phase II, Randomized, Double -Blind, Placebo-Controlled Study to Determine the Efficacy of Black Cohosh, Red Clover and Prempro(r) in the Management of Hot Flashes. Participants will include up to 28 women in each study arm - placebo, Prempro(r), black cohosh, and red clover - for a total n of up to 112. The primary outcome measures will be scores on standardized neuropsychological tests and patterns of brain activation during performance of verbal memory tests. Before treatment and at the end of the 12-month treatment period, participants will complete a 1.5- hour battery of neuropsychological tests that have been shown in previous studies to be sensitive to the effects of HT and menopausal symptoms. Half of the participants (n = 60) will also complete neuroimaging assessments using functional magnetic resonance imaging (fMRI) before and after the 12-month treatment period. The tasks performed in the MRI scanner will be verbal and figural memory tasks shown to be sensitive to HT in midlife women. Findings of group differences in the patterns of brain activation (i.e., regional blood flow changes) will point to the brain areas subserving any treatment-related improvements in memory performance. Recent findings of significant health risks associated with Prempro heighten the need for research into the effects of alternative therapies for menopausal symptoms on cognitive outcomes.
Funding Period: 2004-09-15 - 2008-07-31
more information: NIH RePORT
- Objective cognitive performance is related to subjective memory complaints in midlife women with moderate to severe vasomotor symptomsLauren L Drogos
From the Departments of 1Psychology, 2Psychiatry, and 3Obstetrics and Gynecology, University of Illinois, Chicago, IL and 4Department of Obstetrics and Gynecology and 5Feinberg School of Medicine, Northwestern University, Chicago, IL
Menopause 20:1236-42. 2013..We predicted that subjective memory complaints would be related to affective symptoms and lower performance on tests of memory and attention...
- Effects of botanicals and combined hormone therapy on cognition in postmenopausal womenPauline M Maki
Department of Psychiatry, University of Illinois at Chicago, Chicago, IL 60612, USA
Menopause 16:1167-77. 2009..The aim of this study was to characterize the effects of red clover, black cohosh, and combined hormone therapy on cognitive function in comparison to placebo in women with moderate to severe vasomotor symptoms...
- Objective hot flashes are negatively related to verbal memory performance in midlife womenPauline M Maki
Department of Psychiatry, University of Illinois, Chicago, IL 60612, USA
Menopause 15:848-56. 2008..To test the hypothesis that hot flashes specifically relate to verbal memory performance by examining the relationship between objective hot flashes and cognitive test performance in women with moderate to severe vasomotor symptoms...