Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease

Back to Search
Print
Bookmark Trial

NCT01193608

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Early Phase Investigational Center
Escondido, California, 92025, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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
50-89 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of probable Alzheimer's Disease with MMSE score of 16-26, and brain MRI consistent with the diagnosis of Alzheimer's Disease

- Concurrent use of cholinesterase inhibitor or memantine allowed, if stable.

- Caregiver will participate and be able to attend clinic visits with patient

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


- Significant neurological disease other than Alzheimer's Disease


- Major psychiatric disorder


- Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal
objects in the body)


- Women of childbearing potential

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Alzheimer's DiseaseBapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-Carrier)
NCT00574132
  1. Birmingham, Alabama
  2. Goodyear, Arizona
  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
  22. Los Angeles, California
  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
  34. San Francisco, California
  35. San Francisco, California
  36. Santa Ana, California
  37. Santa Monica, California
  38. Sherman Oaks, California
  39. Walnut Creek, California
  40. Boulder, Colorado
  41. Denver, Colorado
  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
  70. Palm Beach Gardens, Florida
  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
  83. Atlanta, Georgia
  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
  92. Springfield, Illinois
  93. Elkhart, Indiana
  94. Fort Wayne, Indiana
  95. Indianapolis, Indiana
  96. Kansas City, Kansas
  97. Kansas City, Kansas
  98. Lenexa, Kansas
  99. Lexington, Kentucky
  100. Lexington, Kentucky
  101. Paducah, Kentucky
  102. Lake Charles, Louisiana
  103. New Orleans, Louisiana
  104. Shreveport, Louisiana
  105. Shreveport, Louisiana
  106. Scarborough, Maine
  107. Baltimore, Maryland
  108. Baltimore, Maryland
  109. Rockville, Maryland
  110. Belmont, Massachusetts
  111. Boston, Massachusetts
  112. Boston, Massachusetts
  113. Haverhill, Massachusetts
  114. Newton, Massachusetts
  115. Pittsfield, Massachusetts
  116. Plymouth, Massachusetts
  117. Springfield, Massachusetts
  118. Springfield, Massachusetts
  119. Weymouth, Massachusetts
  120. Ann Arbor, Michigan
  121. Detroit, Michigan
  122. East Lansing, Michigan
  123. Grand Rapids, Michigan
  124. Kalamazoo, Michigan
  125. Rochester, Minnesota
  126. Flowood, Mississippi
  127. Hattiesburg, Mississippi
  128. Kansas City, Missouri
  129. Kansas City, Missouri
  130. St. Louis, Missouri
  131. St. Louis, Missouri
  132. Billings, Montana
  133. Great Falls, Montana
  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
  209. Bennington, Vermont
  210. Burlington, Vermont
  211. Alexandria, Virginia
  212. Charlottesville, Virginia
  213. Richmond, Virginia
  214. Seattle, Washington
  215. Seattle, Washington
  216. Wenatchee, Washington
  217. Madison, Wisconsin
  218. Milwaukee, Wisconsin
  219. Waukesha, Wisconsin
  220. Graz, Styria
  221. Wien, Vienna
  222. Calgary, Alberta
  223. Kamloops, British Columbia
  224. Kelowna, British Columbia
  225. Penticton, British Columbia
  226. Vancouver, British Columbia
  227. Kingston, Ontario
  228. London, Ontario
  229. London, Ontario
  230. Ottawa, Ontario
  231. Peterborough, Ontario
  232. Toronto, Ontario
  233. Toronto, Ontario
  234. Whitby, Ontario
  235. Greenfield Park, Quebec
  236. Montreal, Quebec
  237. Montréal, Quebec
  238. Sherbrooke, Quebec
  239. Verdun, Quebec
  240. Tübingen, Baden-wuerttemberg
  241. Ulm, Baden-wuerttemberg
  242. Freiburg, Baden-Württemberg
  243. Günzburg, Bayern
  244. München, Bayern
  245. München, Bayern
  246. Regensburg, Byern
  247. Bochum, Nordrhein-westfalen
  248. Homburg/Saar, Saarland
  249. Leipzig, Sachen
  250. Dresden, Saschen
  251. Hamburg,
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Alzheimer's DiseaseA Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease
NCT00937352
  1. Birmingham, Alabama
  2. Goodyear, Arizona
  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. La Jolla, California
  16. La Jolla, California
  17. Laguna Hills, California
  18. Long Beach, California
  19. Los Alamitos, California
  20. Los Angeles, California
  21. Newport Beach, California
  22. Oceanside, California
  23. Orange, California
  24. Pasadena, California
  25. Sacramento, California
  26. Sacramento, California
  27. San Diego, California
  28. San Diego, California
  29. San Francisco, California
  30. San Francisco, California
  31. Santa Monica, California
  32. Sherman Oaks, California
  33. Walnut Creek, California
  34. Boulder, Colorado
  35. Denver, Colorado
  36. Fort Collins, Colorado
  37. Danbury, Connecticut
  38. Fairfield, Connecticut
  39. New Haven, Connecticut
  40. New Haven, Connecticut
  41. Norwalk, Connecticut
  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
  95. Boston, Massachusetts
  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
  149. East Providence, Rhode Island
  150. Providence, Rhode Island
  151. Providence, Rhode Island
  152. North Charleston, South Carolina
  153. Sioux Falls, South Dakota
  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
  190. Sherbrooke, Quebec
  191. Verdun, Quebec
ALL GENDERS
51 Years+
years
MULTIPLE SITES
Alzheimer's DiseaseDetection of Disease-Related Changes in Pre-Symptomatic Alzheimer's Disease
NCT01841905
  1. Providence, Rhode Island
ALL GENDERS
55 Years+
years
MULTIPLE SITES
Alzheimer's DiseaseAAB-001 in Patients With Mild to Moderate Alzheimer's Disease
NCT00112073
  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
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease
Official Title  ICMJE A Phase 1, Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive, Multiple Ascending Dose Study Of The Safety, Tolerability And Pharmacokinetics Of Aab-003 (Pf-05236812) In Subjects With Mild To Moderate Alzheimer's Disease
Brief Summary This is a study to evaluate the safety of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients will receive either AAB-003 (PF-05236812) or placebo. Each patient's participation will last approximately 41 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: AAB-003 (PF-05236812)
    0.5 mg/kg AAB-003, IV
  • Drug: AAB-003 (PF-05236812)
    1 mg/kg AAB-003, IV
  • Drug: AAB-003 (PF-05236812)
    2 mg/kg AAB-003, IV
  • Drug: AAB-003 (PF-05236812)
    4 mg/kg AAB-003, IV
  • Drug: AAB-003 (PF-05236812)
    8 mg/kg AAB-003, IV
  • Other: Placebo
    Placebo, IV
Study Arms  ICMJE
  • Experimental: 0.5 mg/kg AAB-003
    Intervention: Drug: AAB-003 (PF-05236812)
  • Experimental: 1 mg/kg AAB-003
    Intervention: Drug: AAB-003 (PF-05236812)
  • Experimental: 2 mg/kg AAB-003
    Intervention: Drug: AAB-003 (PF-05236812)
  • Experimental: 4 mg/kg AAB-003
    Intervention: Drug: AAB-003 (PF-05236812)
  • Experimental: 8 mg/kg AAB-003
    Intervention: Drug: AAB-003 (PF-05236812)
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications * Delnomdedieu M, Duvvuri S, Li DJ, Atassi N, Lu M, Brashear HR, Liu E, Ness S, Kupiec JW. First-In-Human safety and long-term exposure data for AAB-003 (PF-05236812) and biomarkers after intravenous infusions of escalating doses in patients with mild to moderate Alzheimer's disease. Alzheimers Res Ther. 2016 Mar 1;8(1):12. doi: 10.1186/s13195-016-0177-y.

*   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
Actual Enrollment  ICMJE
 (submitted: November 19, 2013)		88
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2010)		80
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's Disease with MMSE score of 16-26, and brain MRI consistent with the diagnosis of Alzheimer's Disease
  • Concurrent use of cholinesterase inhibitor or memantine allowed, if stable.
  • Caregiver will participate and be able to attend clinic visits with patient

Exclusion Criteria:

  • Significant neurological disease other than Alzheimer's Disease
  • Major psychiatric disorder
  • Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)
  • Women of childbearing potential
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years to 89 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 Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01193608
Other Study ID Numbers  ICMJE B2601001
3245K1-1000 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2017

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