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From the Department of Neurology, University of Tennessee Health Science Center, and Memphis VAMC, Memphis, TN (A.P.A.); Johnson & Johnson Pharmaceutical Research and Development, L.L.C., La Jolla, CA (H.R.B., C.G.-M.); Director of Neurology and The Memory Disorders Program, Butler Hospital, Providence, RI (S.S.); Sieratzki Chair of Neurology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv-Yafo, Israel (A.D.K.); and Department of Neurology, General Hospital Middelheim, University of Antwerp, Antwerp, Belgium (P.P.D.D.).
Address correspondence and reprint requests to Dr. Alexander P. Auchus, University of Tennessee Health Science Center, Department of Neurology, 855 Monroe Avenue, Suite 415, Memphis, TN 38163 aauchus{at}utmem.edu
Background: To evaluate efficacy and safety of galantamine for patients with vascular dementia (VaD).
Methods: In this multinational, randomized, double-blind, placebo-controlled, parallel-group clinical trial, 788 patients with probable VaD who also satisfied strict centrally read MRI criteria were randomized to receive galantamine or placebo. Efficacy was evaluated using measures of cognition, daily function, and behavior. The primary efficacy measures were the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog/11) and the Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL) total score. Secondary outcomes included the Clinician's Interview Based on Impression of Change-Plus Caregiver Input (CIBIC-plus), Neuropsychiatric Inventory, and EXIT-25 for assessment of executive functioning. Safety and tolerability were also monitored.
Results: Patients treated with galantamine had a greater improvement in ADAS-cog/11 after 26 weeks compared with placebo (–1.8 vs –0.3; p < 0.001). There was no difference between galantamine and placebo at week 26 on the ADCS-ADL score (0.7 vs 1.3; p = 0.783). Improvement in global functioning measured by the CIBIC-plus associated with galantamine approached significance (p = 0.069). A difference between treatment groups for EXIT-25 favoring galantamine was detected (p = 0.041). Safety data revealed that 13% of galantamine and 6% of placebo patients discontinued treatment because of adverse events.
Conclusions: Significance was not reached for both co-primary endpoints. Galantamine was effective for improving cognition, including executive function, in patients with vascular dementia, with good safety and tolerability. However, improvement in activities of daily living with galantamine was similar to that observed with placebo.
Disclosures: Dr. Auchus has received research grant support exceeding $10,000 from Johnson & Johnson, Pfizer/Eisai, Neurochem, and Avanir. He has served as a consultant for Johnson & Johnson, Pfizer, Avanir, and Forest and has received honoraria from Pfizer, Forest, and Novartis. Drs. Brashear and Gassmann-Mayer are full employees of Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Dr. Gassmann-Mayer conducted the statistical analysis. Dr. Salloway has received research support and honoraria and has served as a consultant for Johnson & Johnson, Eisai, Pfizer, Forest, and Myriad Pharmaceuticals. He receives research support from Elan, Neurochem, Voyager, and the National Institutes of Health. He serves as a consultant for Merck and Sanofi-Aventis. Dr. Korczyn has not reported any disclosures. Dr. De Deyn has been a consultant for, and has served on advisory boards for, Johnson & Johnson, Bristol-Myers Squibb, Novartis, and AstraZeneca. He is a member of speakers' bureaus for Johnson & Johnson, Bristol-Myers Squibb, and Lundbeck. He has received clinical and/or preclinical study grants from Johnson & Johnson and Lundbeck.
Received February 23, 2006. Accepted in final form March 2, 2007.
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