These clinical study results are supplied for informational purposes only in the interests of scientific disclosure. They are not intended to substitute for the FDA-approved package insert or other approved labeling. Drug Details Company Name Business Partner Drug Name Generic Name Studied Indications or Disease Phase Approved Drug Label Janssen L.P. RAZADYNE™ galantamine hydrobromide Alzheimer's Mild Cognitive Impairment (MCI) Alzheimer's Disease + Cerebrovascular Disease (AD + CVD) Phase III http://www.razadyne.com/active/janus/en_US/assets/common/company/pi/razadyne.pdf Clinical Study Summary Efficacy and Safety of Galantamine in Patients with Mild to Moderate Alzheimer’s Disease: Multicentre, Randomized Controlled Trial Wilcock GK, Lilienfeld S, Gaens E. Efficacy and Safety of Galantamine in Patients with Mild to Moderate Alzheimer’s Disease: Multicentre, Randomized Controlled Trial. Br Med J 2000;321:1-7. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11110737 -------------------------------------------------- Galantamine in AD: A 6-Month Randomized, Placebo-Controlled Trial with a 6-Month Extension Raskind MA, Peskind ER, Wessel T, Yuan W. Galantamine in AD: A 6-Month Randomized, Placebo-Controlled Trial with a 6-Month Extension. Neurology 2000;54:2261-2268. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=10881250 -------------------------------------------------- A 5-Month, Randomized, Placebo-Controlled Trial of Galantamine in AD Tariot PN, Solomon PR, Morris JC, Kershaw P, Lilienfeld S, Ding C. A 5-Month, Randomized, Placebo-Controlled Trial of Galantamine in AD. Neurology 2000;54:2269-2276. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=10881251 -------------------------------------------------- Effects of a Flexible Galantamine Dose in Alzheimer’s Disease: A Randomized, Controlled Trial Rockwood K, Mintzer J, Truyen L, Wessel T, Wilkinson D. Effects of a Flexible Galantamine Dose in Alzheimer’s Disease: A Randomized, Controlled Trial. J Neurol Neurosurg Psychiatry 2001;71:589-595. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11606667 ------------------------------------------------- Efficacy of Galantamine in Probable Vascular Dementia and Alzheimer's Disease Combined with Cerebrovascular Disease: A Randomised Trial Erkinjuntti T, Kurz A, Gauthier S, Bullock R, Lilienfeld S, Damaraju CV. Efficacy of Galantamine in Probable Vascular Dementia and Alzheimer's Disease Combined with Cerebrovascular Disease: A Randomised Trial. The Lancet. 2002 Apr 13;359(9314):1283-90. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11965273 ------------------------------------------------- Company Study Placebo-Controlled Evaluation of Galantamine in the Treatment of Alzheimer’s Disease: Safety and Efficacy of a Controlled-Release Formulation A Randomized Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Galantamine in Subjects with Mild Cognitive Impairment (MCI) Clinically at Risk for Development of Clinically Probable Alzheimer’s Disease A Randomized Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Galantamine in Subjects with Mild Cognitive Impairment (MCI) Clinically at Risk for Development of Clinically Probable Alzheimer’s Disease An Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Galantamine in the Treatment of Mild Cognitive Impairment (Interim Analysis) An Analysis of Mortality in Subjects who Participated in Three Studies of Galantamine in Mild Cognitive Impairment A Randomized, 26-Week, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Dementia Secondary to Cerebrovascular Disease Back to Search Results