Alzheimer's DiseasePhase 3NCT00151502
To Evaluate the Safety and Effectiveness of Atorvastatin Plus a Cholinesterase Inhibitor in AD Patients.
A Phase 3 study testing Atorvastatin in people with Alzheimer's Disease, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 99 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Atorvastatin
- How many people
- 600 participants
- Where
- 99 sitesin 10 countries
- Study dates
- Nov 2002to Jul 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
99 sites in 10 countries.
99 sites in 10 countries
United States40 sites
Pfizer Investigational Site
Albany, New York, 12208
Pfizer Investigational Site
Albuquerque, New Mexico, 87102
Pfizer Investigational Site
Allentown, Pennsylvania, 18013
Pfizer Investigational Site
Allentown, Pennsylvania, 18103
Pfizer Investigational Site
Austin, Texas, 78756-3433
Pfizer Investigational Site
Dallas, Texas, 75235
Pfizer Investigational Site
East Providence, Rhode Island, 02914
Pfizer Investigational Site
Fort Lauderdale, Florida, 33321
Pfizer Investigational Site
Fort Myers, Florida, 33912
Pfizer Investigational Site
Fort Wayne, Indiana, 46805
Pfizer Investigational Site
Fresno, California, 93720
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Jamesburg, New Jersey, 08831
Pfizer Investigational Site
Jenkintown, Pennsylvania, 19046
Pfizer Investigational Site
Kalamazoo, Michigan, 49048-1640
Pfizer Investigational Site
Laguna Hills, California, 92653
Pfizer Investigational Site
Madison, Tennessee, 37115
Pfizer Investigational Site
Madison, Wisconsin, 53705
Pfizer Investigational Site
Miami Beach, Florida, 33154
Pfizer Investigational Site
Milwaukee, Wisconsin, 53226
Pfizer Investigational Site
New Orleans, Louisiana, 70112
Pfizer Investigational Site
Paducah, Kentucky, 42003
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15205
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213
Pfizer Investigational Site
Pompano Beach, Florida, 33064
Pfizer Investigational Site
Princeton, New Jersey, 08540
Pfizer Investigational Site
Providence, Rhode Island, 02906
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Rochester, New York, 14620
Pfizer Investigational Site
San Francisco, California, 94109
Pfizer Investigational Site
Seattle, Washington, 98108
Pfizer Investigational Site
South Dartmouth, Massachusetts, 02747
Pfizer Investigational Site
St. Petersburg, Florida, 33702
Pfizer Investigational Site
Sun City, Arizona, 85351
Pfizer Investigational Site
Troy, New York, 12180
Pfizer Investigational Site
Tulsa, Oklahoma, 74104
Pfizer Investigational Site
West Palm Beach, Florida, 33407
Pfizer Investigational Site
West Yarmouth, Massachusetts, 02673
Pfizer Investigational Site
Wichita Falls, Texas, 76309
Pfizer Investigational Site
Worcester, Massachusetts, 01655
United Kingdom10 sites
Pfizer Investigational Site
Bath, BA2 5RP
Pfizer Investigational Site
Belfast, BT9 7BL
Pfizer Investigational Site
Bradford, England, BD5 OBS
Pfizer Investigational Site
Glasgow, G20 0XA
Pfizer Investigational Site
Glasgow, G51 4TF
Pfizer Investigational Site
Penarth, CF642XX
Pfizer Investigational Site
Southhampton, SO30 3JB
Pfizer Investigational Site
Stirling, Stirlingshire, FK8 1PH
Pfizer Investigational Site
Stirling, FK8 1RW
Pfizer Investigational Site
Swindon, Wiltshire, SN1 4JU
Canada9 sites
Pfizer Investigational Site
Calgary, Alberta, T2N 4N1
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 2E1
Pfizer Investigational Site
London, Ontario, N6C 5J1
Pfizer Investigational Site
Montreal, Quebec, H1T 2M4
Pfizer Investigational Site
Montreal, Quebec, H3T 1E2
Pfizer Investigational Site
Québec, Quebec, G1J 1Z4
Pfizer Investigational Site
Toronto, Ontario, M4N 3M5
Pfizer Investigational Site
Vancouver, British Columbia, V6T 2B5
Pfizer Investigational Site
Verdun, Quebec, H4H-1R3
Germany9 sites
Pfizer Investigational Site
Bad Honnef, 53604
Pfizer Investigational Site
Berlin, 13347
Pfizer Investigational Site
Bochum, D-44892
Pfizer Investigational Site
Bonn, 53105
Pfizer Investigational Site
Göttingen, 37073
Pfizer Investigational Site
Hanover, 30559
Pfizer Investigational Site
München, 80336
Pfizer Investigational Site
München, 81675
Pfizer Investigational Site
Tübingen, 72076
Australia7 sites
Pfizer Investigational Site
Ballarat, Victoria, 3350
Pfizer Investigational Site
Daw Park, South Australia, 5041
Pfizer Investigational Site
East Gosford, New South Wales, 2250
Pfizer Investigational Site
Nedlands, Western Australia, 6009
Pfizer Investigational Site
Randwick, New South Wales, 2031
Pfizer Investigational Site
WEST Heidelberg, Victoria, 3081
Pfizer Investigational Site
Woodville South, South Australia, 5011
Spain6 sites
Pfizer Investigational Site
Barcelona, 08003
Pfizer Investigational Site
Barcelona, 08014
Pfizer Investigational Site
Barcelona, 08036
Pfizer Investigational Site
Madrid, 28046
Pfizer Investigational Site
Madrid, 28050
Pfizer Investigational Site
Terrassa, Barcelona, 08221
Denmark5 sites
Pfizer Investigational Site
Aarhus, 8000
Pfizer Investigational Site
Copenhagen, 2100
Pfizer Investigational Site
Hillerød, 3400
Pfizer Investigational Site
Rudkøbing, 5900
Pfizer Investigational Site
Svendborg, 5700
South Africa5 sites
Pfizer Investigational Site
Belleville, 7530
Pfizer Investigational Site
Pinetown, KwaZulu-Natal, 3600
Pfizer Investigational Site
Rosebank, Gauteng, 2196
Pfizer Investigational Site
Westville, 3630
Pfizer Investigational Site
Willows, Gauteng, 0041
Sweden5 sites
Pfizer Investigational Site
Linköping, SE-58185
Pfizer Investigational Site
Malmö, SE-20502
Pfizer Investigational Site
Mölndal, SE-43180
Pfizer Investigational Site
Stockholm, 18146
Pfizer Investigational Site
Uddevalla, SE-45180
Austria3 sites
Pfizer Investigational Site
Vienna, A-1030
Pfizer Investigational Site
Vienna, A-1220
Pfizer Investigational Site
Wein, A-1130
About this study
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.
The purpose of this study is to find out if atovastatin, when taken with a cholinesterase inhibitor, is effective for treating Alzheimer's disease.
- Conditions
- Alzheimer's Disease
- Being tested
- Atorvastatin
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startNov 2002
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151502
- Sponsor's protocol ID
- A2581078
- Status last verified
- Feb 2021
- First submitted
- 6 Sep 2005
- Last updated
- 18 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00151502
- Acronym / sponsor ID
- A2581078
- Conditions
- Alzheimer's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- Jul 2007 (actual)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if atovastatin, when taken with a cholinesterase inhibitor, is effective for treating Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin | Drug | – |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
99 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin in people with Alzheimer's Disease, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 99 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 99 sites in United States, United Kingdom, Canada, Germany, Australia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.