期刊
NEUROLOGY
卷 77, 期 13, 页码 1263-1271出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1212/WNL.0b013e318230a16c
关键词
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资金
- NIH/NIA [U01 AG 10483]
- Abbott
- Avid Radiopharmaceuticals, Inc.
- Eli Lilly and Company
- NIH/NIA
- Pfizer Inc
- Bayer Schering Pharma
- Baxter International Inc.
- Astellas Pharma Inc.
- Avanir Pharmaceuticals
- Bristol-Myers Squibb
- Genentech, Inc.
- Lundbeck Inc.
- Novartis
- Pfizer Inc.
- Sidell-Kagan Foundation
- Neuropsychiatric Inventory
- Allon Therapeutics, Inc.
- Mayo Foundation
- Nestle and Kenes International
- Merck Co.
- Radiopharmaceuticals Inc.
- NIH
- Veterans Administration
- State of California
- US Department of Defense
- AstraZeneca
- Elan Pharmaceuticals
- Forest Laboratories, Inc.
- Johnson Johnson
- Myriad Genetics, Inc.
- Takeda Pharmaceutical Company Limited
- Wyeth
- Baxter
- Pfizer
- NIH (NIA, NIMH)
- Alzheimer's Association
- GlaxoSmithKline
- Janssen
- Medivation, Inc.
- Merck Serono
- Toyama Chemical, Co., Ltd.
Objective: We evaluated the effect of the divalproex sodium formulation of valproic acid on brain volumes using MRI in people with mild to moderate Alzheimer disease (AD) and assessed for changes associated with behavioral and cognitive effects. Methods: Eighty-nine of 313 participants randomized to divalproex or placebo in a 24-month, parallel-group trial received MRI scans at baseline and 12 months. Interval MRI annual percent changes in whole brain, ventricular, and hippocampal volumes were the primary outcomes of interest. Change from baseline in clinical outcomes was assessed at 6-month intervals. Results: There were no baseline differences between active treatment and placebo groups in age, education, brain volumes, clinical rating scores, or APOE epsilon 4 carrier status. The group treated with divalproex showed a greater rate of decline in left and right hippocampal and brain volumes (-10.9% and -12.4% vs -5.6% and -6.3%, and -3.5% vs -1.4%, respectively), and a greater rate of ventricular expansion (24.5% vs 9.9%) (p < 0.001). Mini-Mental State Examination scores showed a more rapid decline with divalproex through month 12 (placebo = -2.0 +/- 4.3, divalproex = -3.9 +/- 4.0) (p = 0.037), although there were no changes on other cognitive, behavioral, or functional ratings at 12 and 24 months. Conclusions: Divalproex treatment was associated with accelerated brain volume loss over 1 year and perhaps with greater cognitive impairment. The long-term clinical effects of these changes are not known. Neurology (R) 2011; 77: 1263-1271
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