To Evaluate the Safety and Effectiveness of Atorvastatin Plus a Cholinesterase Inhibitor in AD Patients.
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00151502
Collaborator
(none)
600
99
56
6.1
0.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
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.
Study Start Date
:
Nov 1, 2002
Actual Study Completion Date
:
Jul 1, 2007
Outcome Measures
Primary Outcome Measures
- If the results of this study demonstrate efficacy and lead to the approval by the FDA of atorvastatin for use in humans for the treatment of Alzheimer's disease, this would be available as an additional treatment option for patients. []
Secondary Outcome Measures
- If the results of this study demonstrate efficacy and lead to the approval by the Food and Drug Administration of atorvastatin for use in humans, subject activities of daily living are being assessed. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Sun City | Arizona | United States | 85351 |
| 2 | Pfizer Investigational Site | Fresno | California | United States | 93720 |
| 3 | Pfizer Investigational Site | Laguna Hills | California | United States | 92653 |
| 4 | Pfizer Investigational Site | San Francisco | California | United States | 94109 |
| 5 | Pfizer Investigational Site | Fort Lauderdale | Florida | United States | 33321 |
| 6 | Pfizer Investigational Site | Fort Myers | Florida | United States | 33912 |
| 7 | Pfizer Investigational Site | Miami Beach | Florida | United States | 33154 |
| 8 | Pfizer Investigational Site | Pompano Beach | Florida | United States | 33064 |
| 9 | Pfizer Investigational Site | Saint Petersburg | Florida | United States | 33702 |
| 10 | Pfizer Investigational Site | West Palm Beach | Florida | United States | 33407 |
| 11 | Pfizer Investigational Site | Fort Wayne | Indiana | United States | 46805 |
| 12 | Pfizer Investigational Site | Paducah | Kentucky | United States | 42003 |
| 13 | Pfizer Investigational Site | New Orleans | Louisiana | United States | 70112 |
| 14 | Pfizer Investigational Site | South Dartmouth | Massachusetts | United States | 02747 |
| 15 | Pfizer Investigational Site | West Yarmouth | Massachusetts | United States | 02673 |
| 16 | Pfizer Investigational Site | Worcester | Massachusetts | United States | 01655 |
| 17 | Pfizer Investigational Site | Kalamazoo | Michigan | United States | 49048-1640 |
| 18 | Pfizer Investigational Site | Jamesburg | New Jersey | United States | 08831 |
| 19 | Pfizer Investigational Site | Princeton | New Jersey | United States | 08540 |
| 20 | Pfizer Investigational Site | Albuquerque | New Mexico | United States | 87102 |
| 21 | Pfizer Investigational Site | Albany | New York | United States | 12208 |
| 22 | Pfizer Investigational Site | Rochester | New York | United States | 14620 |
| 23 | Pfizer Investigational Site | Troy | New York | United States | 12180 |
| 24 | Pfizer Investigational Site | Tulsa | Oklahoma | United States | 74104 |
| 25 | Pfizer Investigational Site | Allentown | Pennsylvania | United States | 18013 |
| 26 | Pfizer Investigational Site | Allentown | Pennsylvania | United States | 18103 |
| 27 | Pfizer Investigational Site | Jenkintown | Pennsylvania | United States | 19046 |
| 28 | Pfizer Investigational Site | Pittsburgh | Pennsylvania | United States | 15205 |
| 29 | Pfizer Investigational Site | Pittsburgh | Pennsylvania | United States | 15213 |
| 30 | Pfizer Investigational Site | East Providence | Rhode Island | United States | 02914 |
| 31 | Pfizer Investigational Site | Providence | Rhode Island | United States | 02906 |
| 32 | Pfizer Investigational Site | Madison | Tennessee | United States | 37115 |
| 33 | Pfizer Investigational Site | Austin | Texas | United States | 78756-3433 |
| 34 | Pfizer Investigational Site | Dallas | Texas | United States | 75235 |
| 35 | Pfizer Investigational Site | Houston | Texas | United States | 77030 |
| 36 | Pfizer Investigational Site | Wichita Falls | Texas | United States | 76309 |
| 37 | Pfizer Investigational Site | Richmond | Virginia | United States | 23294 |
| 38 | Pfizer Investigational Site | Seattle | Washington | United States | 98108 |
| 39 | Pfizer Investigational Site | Madison | Wisconsin | United States | 53705 |
| 40 | Pfizer Investigational Site | Milwaukee | Wisconsin | United States | 53226 |
| 41 | Pfizer Investigational Site | East Gosford | New South Wales | Australia | 2250 |
| 42 | Pfizer Investigational Site | Randwick | New South Wales | Australia | 2031 |
| 43 | Pfizer Investigational Site | Daw Park | South Australia | Australia | 5041 |
| 44 | Pfizer Investigational Site | Woodville South | South Australia | Australia | 5011 |
| 45 | Pfizer Investigational Site | Ballarat | Victoria | Australia | 3350 |
| 46 | Pfizer Investigational Site | WEST Heidelberg | Victoria | Australia | 3081 |
| 47 | Pfizer Investigational Site | Nedlands | Western Australia | Australia | 6009 |
| 48 | Pfizer Investigational Site | Wein | Austria | A-1130 | |
| 49 | Pfizer Investigational Site | Wien | Austria | A-1030 | |
| 50 | Pfizer Investigational Site | Wien | Austria | A-1220 | |
| 51 | Pfizer Investigational Site | Calgary | Alberta | Canada | T2N 4N1 |
| 52 | Pfizer Investigational Site | Vancouver | British Columbia | Canada | V6T 2B5 |
| 53 | Pfizer Investigational Site | Halifax | Nova Scotia | Canada | B3H 2E1 |
| 54 | Pfizer Investigational Site | London | Ontario | Canada | N6C 5J1 |
| 55 | Pfizer Investigational Site | Toronto | Ontario | Canada | M4N 3M5 |
| 56 | Pfizer Investigational Site | Montreal | Quebec | Canada | H1T 2M4 |
| 57 | Pfizer Investigational Site | Montreal | Quebec | Canada | H3T 1E2 |
| 58 | Pfizer Investigational Site | Verdun | Quebec | Canada | H4H-1R3 |
| 59 | Pfizer Investigational Site | Quebec | Canada | G1J 1Z4 | |
| 60 | Pfizer Investigational Site | Aarhus | Denmark | 8000 | |
| 61 | Pfizer Investigational Site | Copenhagen | Denmark | 2100 | |
| 62 | Pfizer Investigational Site | Hillerod | Denmark | 3400 | |
| 63 | Pfizer Investigational Site | Rudkobing | Denmark | 5900 | |
| 64 | Pfizer Investigational Site | Svendborg | Denmark | 5700 | |
| 65 | Pfizer Investigational Site | Bad Honnef | Germany | 53604 | |
| 66 | Pfizer Investigational Site | Berlin | Germany | 13347 | |
| 67 | Pfizer Investigational Site | Bochum | Germany | D-44892 | |
| 68 | Pfizer Investigational Site | Bonn | Germany | 53105 | |
| 69 | Pfizer Investigational Site | Goettingen | Germany | 37073 | |
| 70 | Pfizer Investigational Site | Hannover | Germany | 30559 | |
| 71 | Pfizer Investigational Site | Muenchen | Germany | 80336 | |
| 72 | Pfizer Investigational Site | Muenchen | Germany | 81675 | |
| 73 | Pfizer Investigational Site | Tuebingen | Germany | 72076 | |
| 74 | Pfizer Investigational Site | Rosebank | Gauteng | South Africa | 2196 |
| 75 | Pfizer Investigational Site | Willows | Gauteng | South Africa | 0041 |
| 76 | Pfizer Investigational Site | Pinetown | Kwazulu Natal | South Africa | 3600 |
| 77 | Pfizer Investigational Site | Belleville | South Africa | 7530 | |
| 78 | Pfizer Investigational Site | Westville | South Africa | 3630 | |
| 79 | Pfizer Investigational Site | Terrassa | Barcelona | Spain | 08221 |
| 80 | Pfizer Investigational Site | Barcelona | Spain | 08003 | |
| 81 | Pfizer Investigational Site | Barcelona | Spain | 08014 | |
| 82 | Pfizer Investigational Site | Barcelona | Spain | 08036 | |
| 83 | Pfizer Investigational Site | Madrid | Spain | 28046 | |
| 84 | Pfizer Investigational Site | Madrid | Spain | 28050 | |
| 85 | Pfizer Investigational Site | Linkoeping | Sweden | SE-58185 | |
| 86 | Pfizer Investigational Site | Malmoe | Sweden | SE-20502 | |
| 87 | Pfizer Investigational Site | Moelndal | Sweden | SE-43180 | |
| 88 | Pfizer Investigational Site | Stockholm | Sweden | 18146 | |
| 89 | Pfizer Investigational Site | Uddevalla | Sweden | SE-45180 | |
| 90 | Pfizer Investigational Site | Bradford | England | United Kingdom | BD5 OBS |
| 91 | Pfizer Investigational Site | Stirling | Stirlingshire | United Kingdom | FK8 1PH |
| 92 | Pfizer Investigational Site | Swindon | Wiltshire | United Kingdom | SN1 4JU |
| 93 | Pfizer Investigational Site | Bath | United Kingdom | BA2 5RP | |
| 94 | Pfizer Investigational Site | Belfast | United Kingdom | BT9 7BL | |
| 95 | Pfizer Investigational Site | Glasgow | United Kingdom | G20 0XA | |
| 96 | Pfizer Investigational Site | Glasgow | United Kingdom | G51 4TF | |
| 97 | Pfizer Investigational Site | Penarth | United Kingdom | CF642XX | |
| 98 | Pfizer Investigational Site | Southhampton | United Kingdom | SO30 3JB | |
| 99 | Pfizer Investigational Site | Stirling | United Kingdom | FK8 1RW |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00151502
Other Study ID Numbers:
- A2581078
First Posted:
Sep 9, 2005
Last Update Posted:
Feb 18, 2021
Last Verified:
Feb 1, 2021