To Evaluate the Safety and Effectiveness of Atorvastatin Plus a Cholinesterase Inhibitor in AD Patients.

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NCT00151502

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-90 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnostic evidence of probable Alzheimer's disease consistent with NINCDS/ADRDA and DSM IV criteria.

- Subject's Mini-Mental Status Examination Score (MMSE) must be in the range of 13 - 25 (inclusive) at Screening.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subjects with dementia due to causes other than Alzheimer's disease.


- Any condition, which, in the investigator's judgment might increase the risk to the
subject or decrease the reliability of the data required to meet the objectives of the
study.

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  3. Phoenix, Arizona
  4. Phoenix, Arizona
  5. Sun City, Arizona
  6. Tucson, Arizona
  7. Tucson, Arizona
  8. Little Rock, Arkansas
  9. Berkeley, California
  10. Carson, California
  11. Costa Mesa, California
  12. Encino, California
  13. Fresno, California
  14. Fullerton, California
  15. Glendale, California
  16. Imperial, California
  17. La Jolla, California
  18. La Jolla, California
  19. Laguna Hills, California
  20. Long Beach, California
  21. Los Alamitos, California
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  23. Los Angeles, California
  24. National City, California
  25. Newport Beach, California
  26. Oceanside, California
  27. Orange, California
  28. Pasadena, California
  29. Rancho Mirage, California
  30. Sacramento, California
  31. Sacramento, California
  32. San Diego, California
  33. San Diego, California
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  36. Santa Ana, California
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  38. Sherman Oaks, California
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  42. Fort Collins, Colorado
  43. Danbury, Connecticut
  44. Fairfield, Connecticut
  45. New Haven, Connecticut
  46. New Haven, Connecticut
  47. Norwalk, Connecticut
  48. Waterbury, Connecticut
  49. Newark, Delaware
  50. Washington, District of Columbia
  51. Atlantis, Florida
  52. Bradenton, Florida
  53. Deerfield Beach, Florida
  54. Delray Beach, Florida
  55. Fort Lauderdale, Florida
  56. Fort Myers, Florida
  57. Fort Walton Beach, Florida
  58. Ft. Myers, Florida
  59. Hallandale Beach, Florida
  60. Hollywood, Florida
  61. Jacksonville, Florida
  62. Maitland, Florida
  63. Melbourne, Florida
  64. Miami, Florida
  65. Miami, Florida
  66. Miami, Florida
  67. Ocala, Florida
  68. Orange City, Florida
  69. Orlando, Florida
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  71. Pembroke Pines, Florida
  72. Port Charlotte, Florida
  73. Sarasota, Florida
  74. South Miami, Florida
  75. St Petersburg, Florida
  76. St. Petersburg, Florida
  77. Tampa, Florida
  78. Tampa, Florida
  79. Tampa, Florida
  80. Tampa, Florida
  81. West Palm Beach, Florida
  82. Atlanta, Georgia
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  84. Atlanta, Georgia
  85. Columbus, Georgia
  86. Decatur, Georgia
  87. Lawrenceville, Georgia
  88. Chicago, Illinois
  89. Chicago, Illinois
  90. Elk Grove Village, Illinois
  91. Peoria, Illinois
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  93. Elkhart, Indiana
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  95. Indianapolis, Indiana
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  98. Lenexa, Kansas
  99. Lexington, Kentucky
  100. Lexington, Kentucky
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  104. Shreveport, Louisiana
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  106. Scarborough, Maine
  107. Baltimore, Maryland
  108. Baltimore, Maryland
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  113. Haverhill, Massachusetts
  114. Newton, Massachusetts
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  119. Weymouth, Massachusetts
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  126. Flowood, Mississippi
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  132. Billings, Montana
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  134. Omaha, Nebraska
  135. Las Vegas, Nevada
  136. Dover, New Hampshire
  137. Lebanon, New Hampshire
  138. Berlin, New Jersey
  139. Eatontown, New Jersey
  140. Manchester, New Jersey
  141. Mount Arlington, New Jersey
  142. Princeton, New Jersey
  143. Stratford, New Jersey
  144. Toms River, New Jersey
  145. Albuquerque, New Mexico
  146. Albuquerque, New Mexico
  147. Albany, New York
  148. Albany, New York
  149. Albany, New York
  150. Brooklyn, New York
  151. Cedarhurst, New York
  152. Elmsford, New York
  153. Latham, New York
  154. Liverpool, New York
  155. New Hyde Park, New York
  156. New York, New York
  157. New York, New York
  158. New York, New York
  159. New York, New York
  160. Orangeburg, New York
  161. Rochester, New York
  162. Durham, North Carolina
  163. Hickory, North Carolina
  164. Hickory, North Carolina
  165. Raleigh, North Carolina
  166. Winston-Salem, North Carolina
  167. Beachwood, Ohio
  168. Canton, Ohio
  169. Canton, Ohio
  170. Cleveland, Ohio
  171. Columbus, Ohio
  172. Dayton, Ohio
  173. Toledo, Ohio
  174. Oklahoma City, Oklahoma
  175. Oklahoma City, Oklahoma
  176. Medford, Oregon
  177. Portland, Oregon
  178. Portland, Oregon
  179. Portland, Oregon
  180. Abington, Pennsylvania
  181. Allentown, Pennsylvania
  182. Jenkintown, Pennsylvania
  183. Philadelphia, Pennsylvania
  184. Philadelphia, Pennsylvania
  185. Philadelphia, Pennsylvania
  186. Pittsburgh, Pennsylvania
  187. Pittsburg, Pennsylvania
  188. East Providence, Rhode Island
  189. Providence, Rhode Island
  190. Providence, Rhode Island
  191. N. Charleston, South Carolina
  192. Sioux Falls, South Dakota
  193. Cordova, Tennessee
  194. Franklin, Tennessee
  195. Johnson City, Tennessee
  196. Knoxville, Tennessee
  197. Austin, Texas
  198. Dallas, Texas
  199. Dallas, Texas
  200. DeSoto, Texas
  201. Fort Worth, Texas
  202. Houston, Texas
  203. Houston, Texas
  204. San Antonio, Texas
  205. San Antonio, Texas
  206. Wichita Falls, Texas
  207. Salt Lake City, Utah
  208. Salt Lake City, Utah
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  210. Burlington, Vermont
  211. Alexandria, Virginia
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  2. Goodyear, Arizona
  3. Phoenix, Arizona
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  5. Sun City, Arizona
  6. Tucson, Arizona
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  8. Little Rock, Arkansas
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  12. Encino, California
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  25. Sacramento, California
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  29. San Francisco, California
  30. San Francisco, California
  31. Santa Monica, California
  32. Sherman Oaks, California
  33. Walnut Creek, California
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  38. Fairfield, Connecticut
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  40. New Haven, Connecticut
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  42. Waterbury, Connecticut
  43. Newark, Delaware
  44. Washington, District of Columbia
  45. Atlantis, Florida
  46. Bradenton, Florida
  47. Deerfield Beach, Florida
  48. Delray Beach, Florida
  49. Fort Lauderdale, Florida
  50. Fort Myers, Florida
  51. Fort Myers, Florida
  52. Fort Walton Beach, Florida
  53. Hallandale Beach, Florida
  54. Jacksonville, Florida
  55. Maitland, Florida
  56. Melbourne, Florida
  57. Miami, Florida
  58. Miami, Florida
  59. Miami, Florida
  60. Miami, Florida
  61. Ocala, Florida
  62. Orlando, Florida
  63. Palm Beach Gardens, Florida
  64. Port Charlotte, Florida
  65. Saint Petersburg, Florida
  66. Sarasota, Florida
  67. Tampa, Florida
  68. Tampa, Florida
  69. Tampa, Florida
  70. Tampa, Florida
  71. West Palm Beach, Florida
  72. Atlanta, Georgia
  73. Atlanta, Georgia
  74. Atlanta, Georgia
  75. Columbus, Georgia
  76. Columbus, Georgia
  77. Decatur, Georgia
  78. Lawrenceville, Georgia
  79. Chicago, Illinois
  80. Elk Grove Village, Illinois
  81. Peoria, Illinois
  82. Springfield, Illinois
  83. Elkhart, Indiana
  84. Indianapolis, Indiana
  85. Kansas City, Kansas
  86. Lenexa, Kansas
  87. Lexington, Kentucky
  88. Lexington, Kentucky
  89. Paducah, Kentucky
  90. Lake Charles, Louisiana
  91. Shreveport, Louisiana
  92. Scarborough, Maine
  93. Rockville, Maryland
  94. Boston, Massachusetts
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  96. Haverhill, Massachusetts
  97. Newton, Massachusetts
  98. Pittsfield, Massachusetts
  99. Plymouth, Massachusetts
  100. Springfield, Massachusetts
  101. Ann Arbor, Michigan
  102. Detroit, Michigan
  103. East Lansing, Michigan
  104. Kalamazoo, Michigan
  105. Rochester, Minnesota
  106. Hattiesburg, Mississippi
  107. Kansas City, Missouri
  108. Saint Louis, Missouri
  109. Saint Lous, Missouri
  110. Billings, Montana
  111. Great Falls, Montana
  112. Omaha, Nebraska
  113. Eatontown, New Jersey
  114. Manchester, New Jersey
  115. Princeton, New Jersey
  116. Toms River, New Jersey
  117. Albuquerque, New Mexico
  118. Albany, New York
  119. Albany, New York
  120. Albany, New York
  121. Elmsford, New York
  122. Latham, New York
  123. Liverpool, New York
  124. New Hyde Park, New York
  125. New York, New York
  126. New York, New York
  127. Orangeburg, New York
  128. Rochester, New York
  129. Durham, North Carolina
  130. Hickory, North Carolina
  131. Raleigh, North Carolina
  132. Canton, Ohio
  133. Columbus, Ohio
  134. Dayton, Ohio
  135. Oklahoma City, Oklahoma
  136. Oklahoma City, Oklahoma
  137. Medford, Oregon
  138. Portland, Oregon
  139. Portland, Oregon
  140. Portland, Oregon
  141. Abington, Pennsylvania
  142. Allentown, Pennsylvania
  143. Jenkintown, Pennsylvania
  144. Philadelphia, Pennsylvania
  145. Philadelphia, Pennsylvania
  146. Philadelphia, Pennsylvania
  147. Pittsburgh, Pennsylvania
  148. Pittsburgh, Pennsylvania
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  151. Providence, Rhode Island
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  154. Cordova, Tennessee
  155. Johnson City, Tennessee
  156. Knoxville, Tennessee
  157. Nashville, Tennessee
  158. Austin, Texas
  159. Dallas, Texas
  160. Dallas, Texas
  161. DeSoto, Texas
  162. Fort Worth, Texas
  163. Houston, Texas
  164. San Antonio, Texas
  165. San Antonio, Texas
  166. Salt Lake City, Utah
  167. Salt Lake City, Utah
  168. Bennington, Vermont
  169. Burlington, Vermont
  170. Alexandria, Virginia
  171. Charlottesville, Virginia
  172. Richmond, Virginia
  173. Seattle, Washington
  174. Seattle, Washington
  175. Milwaukee, Wisconsin
  176. Waukesha, Wisconsin
  177. Graz, Styria
  178. Calgary, Alberta
  179. Kamloops, British Columbia
  180. Kelowna, British Columbia
  181. Kingston, Ontario
  182. London, Ontario
  183. Ottawa, Ontario
  184. Toronto, Ontario
  185. Toronto, Ontario
  186. Whitby, Ontario
  187. Greenfield Park, Quebec
  188. Montréal, Quebec
  189. Montréal, Quebec
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  1. Sun City, Arizona
  2. Irvine, California
  3. Los Alamitos, California
  4. Northridge, California
  5. San Diego, California
  6. San Francisco, California
  7. New Haven, Connecticut
  8. Washington, District of Columbia
  9. Delray Beach, Florida
  10. Jacksonville, Florida
  11. Chicago, Illinois
  12. Indianapolis, Indiana
  13. Boston, Massachusetts
  14. Ann Arbor, Michigan
  15. Rochester, Minnesota
  16. Long Branch, New Jersey
  17. New York City, New York
  18. Rochester, New York
  19. Durham, North Carolina
  20. Portland, Oregon
  21. Pittsburgh, Pennsylvania
  22. Providence, Rhode Island
  23. Dallas, Texas
  24. Houston, Texas
  25. Bennington, Vermont
  26. Seattle, Washington
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Advanced Information
Descriptive Information
Brief Title  ICMJE To Evaluate the Safety and Effectiveness of Atorvastatin Plus a Cholinesterase Inhibitor in AD Patients.
Official Title  ICMJE An 80-Week, Randomized, Multi-Center, Parallel-Group, Double-Blind Study of the Efficacy and Safety of Atorvastatin 80 MG Plus an Acetylcholinesterase Inhibitor Versus an Acetylcholinesterase Inhibitor Alone in the Treatment of Mild to Moderate Alzheimer's Disease.
Brief Summary The purpose of this study is to find out if atovastatin, when taken with a cholinesterase inhibitor, is effective for treating Alzheimer's disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Drug: Atorvastatin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 8, 2005)		600
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnostic evidence of probable Alzheimer's disease consistent with NINCDS/ADRDA and DSM IV criteria.
  • Subject's Mini-Mental Status Examination Score (MMSE) must be in the range of 13 - 25 (inclusive) at Screening.

Exclusion Criteria:

  • Subjects with dementia due to causes other than Alzheimer's disease.
  • Any condition, which, in the investigator's judgment might increase the risk to the subject or decrease the reliability of the data required to meet the objectives of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   Denmark,   Germany,   South Africa,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00151502
Other Study ID Numbers  ICMJE A2581078
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP