A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease

NCT00838110

Last updated date
Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608, United States
Contact
1-800-718-1021

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

- Diagnosis of Alzheimer's Disease.

- MMSE 12-26 inclusive.

- If on existing anti-dementia therapy, have been on a stable dose of anti-dementia therapy (cholinesterase inhibitors and/or memantine) for at least 60 days prior to dosing in study.

- If not taking existing anti-dementia therapy, have not received therapy with cholinesterase inhibitors and/or memantine within 60 days prior to dosing in this study.

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


- Have major structural brain disease (e.g., ischemic infarcts, subdural hematoma,
hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a
single lesion in a critical region [e.g., thalamus, hippocampus]).


- Have any major medical illness or unstable medical condition within six months of
screening that may interfere with the patient's ability to comply with study
procedures and abide by study restrictions.


- Have not been on a stable dose of anti-dementia therapy for at least 60 days prior to
dosing or intend to start anti-dementia therapy during the double blind portion of the
study.


- Reside in a nursing home or assisted care facility with need for 24-hour care and
supervision.

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]

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.

Based on your search, you may also be interested in

Alzheimer's DiseaseA Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease
NCT00838110
  1. Mobile, Alabama
  2. Northport, Alabama
  3. Little Rock, Arkansas
  4. Oceanside, California
  5. San Diego, California
  6. Santa Rosa, California
  7. Pueblo, Colorado
  8. Hockessin, Delaware
  9. Bradenton, Florida
  10. Brooksville, Florida
  11. Clearwater, Florida
  12. Daytona Beach, Florida
  13. Daytona Beach, Florida
  14. Destin, Florida
  15. Fort Myers, Florida
  16. Fort Walton Beach, Florida
  17. Fruitland Park, Florida
  18. Melbourne, Florida
  19. Naples, Florida
  20. Ocala, Florida
  21. Ocala, Florida
  22. Orlando, Florida
  23. Plant City, Florida
  24. Port Charlotte, Florida
  25. Port Orange, Florida
  26. Saint Petersburg, Florida
  27. Saint Petersburg, Florida
  28. Tampa, Florida
  29. Tampa, Florida
  30. Atlanta, Georgia
  31. Burr Ridge, Illinois
  32. Elk Grove Village, Illinois
  33. Elkhart, Indiana
  34. Evansville, Indiana
  35. Fort Wayne, Indiana
  36. Greenfield, Indiana
  37. Prairie Village, Kansas
  38. Wichita, Kansas
  39. Lake Charles, Louisiana
  40. Shreveport, Louisiana
  41. West Yarmouth, Massachusetts
  42. Flowood, Mississippi
  43. Olive Branch, Mississippi
  44. Kansas City, Missouri
  45. Springfield, Missouri
  46. Great Falls, Montana
  47. Eatontown, New Jersey
  48. Oakhurst, New Jersey
  49. Toms River, New Jersey
  50. Albuquerque, New Mexico
  51. Amherst, New York
  52. Buffalo, New York
  53. Buffalo, New York
  54. Orchard Park, New York
  55. Syracuse, New York
  56. Charlotte, North Carolina
  57. Raleigh, North Carolina
  58. Raleigh, North Carolina
  59. Winston-Salem, North Carolina
  60. Fargo, North Dakota
  61. Fargo, North Dakota
  62. Cincinnati, Ohio
  63. Oklahoma City, Oklahoma
  64. Portland, Oregon
  65. Altoona, Pennsylvania
  66. Beaver, Pennsylvania
  67. Bridgeville, Pennsylvania
  68. Grove City, Pennsylvania
  69. Indiana, Pennsylvania
  70. Norristown, Pennsylvania
  71. Pittsburgh, Pennsylvania
  72. Scotland, Pennsylvania
  73. Upper Saint Clair, Pennsylvania
  74. Charleston, South Carolina
  75. Greer, South Carolina
  76. Murrells Inlet, South Carolina
  77. North Charleston, South Carolina
  78. Orangeburg, South Carolina
  79. Sioux Falls, South Dakota
  80. Franklin, Tennessee
  81. Knoxville, Tennessee
  82. Nashville, Tennessee
  83. Carrollton, Texas
  84. Fort Worth, Texas
  85. Fort Worth, Texas
  86. Grand Prairie, Texas
  87. Houston, Texas
  88. Lake Jackson, Texas
  89. Williamsburg, Virginia
  90. Kirkland, Washington
  91. Spokane, Washington
  92. Charleston, West Virginia
  93. La Crosse, Wisconsin
  94. Calgary, Alberta
  95. Medicine Hat, Alberta
  96. Surrey, British Columbia
  97. Victoria, British Columbia
  98. Saint John, New Brunswick
  99. Bay Roberts, Newfoundland and Labrador
  100. Kentville, Nova Scotia
  101. Pictou, Nova Scotia
  102. Burlington, Ontario
  103. Corunna, Ontario
  104. London, Ontario
  105. Sarnia, Ontario
  106. Toronto, Ontario
  107. Greenfield Park, Quebec
  108. L'Ancienne-Lorette, Quebec
  109. Sherbrooke, Quebec
  110. St-Jean-sur-Richelieu, Quebec
  111. St. Leonard, Quebec
  112. Quebec,
  113. Quebec,
  114. Cayey,
  115. Cidra,
  116. Rio Piedras,
  117. San Juan,
  118. San Juan,
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Alzheimer's DiseaseA Phase I, Single Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease
NCT00607308
  1. Hirosaki, Aomori
  2. Fukuoka-shi, Fukuoka
  3. Fukuyama city, Hiroshima
  4. Tsukuba, Ibaraki
  5. Niigata-shi, Niigata
  6. Bunkyo-ku, Tokyo
  7. Kodaira, Tokyo
  8. Kanazawa,
  9. Kyoto,
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Alzheimer's DiseaseStudy Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On Donepezil
NCT01712074
  1. Costa Mesa, California
  2. Imperial, California
  3. Rancho Mirage, California
  4. Santa Ana, California
  5. Hamden, Connecticut
  6. New Haven, Connecticut
  7. New Haven, Connecticut
  8. New Haven, Connecticut
  9. Boynton Beach, Florida
  10. Brooksville, Florida
  11. Deerfield Beach, Florida
  12. Delray Beach, Florida
  13. Hallandale Beach, Florida
  14. Leesburg, Florida
  15. Orange City, Florida
  16. West Palm Beach, Florida
  17. Alpharetta, Georgia
  18. Atlanta, Georgia
  19. Columbus, Georgia
  20. Lake Charles, Louisiana
  21. East Lansing, Michigan
  22. Creve Coeur, Missouri
  23. Creve Coeur, Missouri
  24. New York, New York
  25. Rochester, New York
  26. Rochester, New York
  27. Staten Island, New York
  28. Columbus, Ohio
  29. Columbus, Ohio
  30. Norristown, Pennsylvania
  31. Charleston, South Carolina
  32. Charleston, South Carolina
  33. Charleston, South Carolina
  34. Cordova, Tennessee
  35. Austin, Texas
  36. Wichita Falls, Texas
  37. Bennington, Vermont
  38. Middleton, Wisconsin
  39. Waukesha, Wisconsin
  40. Waukesha, Wisconsin
  41. Halifax, Nova Scotia
  42. Chatham, Ontario
  43. Chatham, Ontario
  44. Gatineau, Quebec
  45. Antofagasta, Ii Region
  46. Santiago, Metropolitana
  47. Santiago, Metropolitana
  48. La Seyne Sur Mer,
  49. Berlin,
  50. Berlin,
  51. Berlin,
  52. Leipzig,
  53. Nuernberg,
  54. Elche, Alicante
  55. Madrid,
  56. Bath,
  57. Cambridge,
  58. Chertsey,
  59. Northampton,
  60. Switzerland,
ALL GENDERS
60 Years+
years
MULTIPLE SITES
Alzheimer's DiseaseSafety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
NCT00959192
  1. Aichi,
  2. Ibaraki,
  3. Kanagawa,
  4. Kanagawa,
  5. Osaka,
  6. Tokyo,
  7. Tokyo,
  8. Tokyo,
  9. Tokyo,
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease
Official Title  ICMJE A Phase 3, Multi-Center, Randomized, Double-Blind Placebo-Controlled Study To Evaluate The Safety And Tolerability Of Dimebon (PF-01913539) For Up To 26-Weeks In Patients With Mild To Moderate Alzheimer's Disease
Brief Summary This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in 2 study cohorts. In Cohort 1, subjects with Alzheimer's disease (n=250) will receive Dimebon 20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with Dimebon 20 mg or placebo TID for 12 weeks After completion of the randomized portion of the study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open label extension study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: Dimebon
    10 mg TID for week 1 followed by 20 mg TID through Week 26
  • Drug: Placebo
    10 mg TID for week 1 followed by 20 mg TID through Week 26
  • Drug: Dimebon
    10 mg TID for week 1 followed by 20 mg TID through Week 12
  • Drug: Placebo
    20 mg matched Placebo (Cohort 2) 10 mg TID for week 1 followed by 20 mg TID through Week 12
Study Arms  ICMJE
  • Experimental: Dimebon 20 mg TID (Cohort 1)
    Intervention: Drug: Dimebon
  • Placebo Comparator: Placebo TID (Cohort 1)
    Intervention: Drug: Placebo
  • Experimental: Dimebon 20 mg TID (Cohort 2)
    Intervention: Drug: Dimebon
  • Placebo Comparator: Placebo TID (Cohort 2)
    Intervention: Drug: Placebo
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
Actual Enrollment  ICMJE
 (submitted: April 5, 2011)
742
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2009)
750
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of Alzheimer's Disease.
  • MMSE 12-26 inclusive.
  • If on existing anti-dementia therapy, have been on a stable dose of anti-dementia therapy (cholinesterase inhibitors and/or memantine) for at least 60 days prior to dosing in study.
  • If not taking existing anti-dementia therapy, have not received therapy with cholinesterase inhibitors and/or memantine within 60 days prior to dosing in this study.

Exclusion Criteria:

  • Have major structural brain disease (e.g., ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a single lesion in a critical region [e.g., thalamus, hippocampus]).
  • Have any major medical illness or unstable medical condition within six months of screening that may interfere with the patient's ability to comply with study procedures and abide by study restrictions.
  • Have not been on a stable dose of anti-dementia therapy for at least 60 days prior to dosing or intend to start anti-dementia therapy during the double blind portion of the study.
  • Reside in a nursing home or assisted care facility with need for 24-hour care and supervision.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (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 Canada,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00838110
Other Study ID Numbers  ICMJE B1451027
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 Medivation, Inc.
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2018

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