Alzheimer's DiseasePhase 2NCT00566397
A Phase 2 Study Evaluating The Efficacy And Safety Of PF 04494700 In Mild To Moderate Alzheimer's Disease
A Phase 2 study testing PF-04494700 in people with Alzheimer's Disease, run by Pfizer at 62 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of PF 04494700 in participants with mild to moderate Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- PF-04494700
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 402 participants
- Where
- 62 sitesUnited States
- Study dates
- Dec 2007to Dec 2010
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mini Mental State Exam (MMSE) score between 14-26 (inclusive) at screening.
- Participants must be receiving acetylcholinesterase inhibitors on a stable dose for at least 4 months prior to randomization
Who cannot join
- Current evidence or history of neurological, psychiatric and any other illness that could contribute to non-Alzheimer's dementia.
- Known history of familial AD or any evidence for early onset AD known or possibly associated with genetic mutations.
- Evidence or history of diabetes mellitus Type 1 or Type 2.
- History or symptoms of autoimmune disorders.
Trial locations and contacts
62 sites in 1 country.
62 sites in 1 country
United States62 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48109
Pfizer Investigational Site
Atlanta, Georgia, 30329-5102
Pfizer Investigational Site
Baltimore, Maryland, 21224
Pfizer Investigational Site
Beachwood, Ohio, 44122
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Charleston, South Carolina, 29425
Pfizer Investigational Site
Chicago, Illinois, 60611
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Dallas, Texas, 75390
Pfizer Investigational Site
Grand Rapids, Michigan, 49503
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Houston, Texas, 77098
Pfizer Investigational Site
Indianapolis, Indiana, 46202
Pfizer Investigational Site
Irvine, California, 92697-1385
Pfizer Investigational Site
Irvine, California, 92697-3959
Pfizer Investigational Site
Irvine, California, 92697-4285
Pfizer Investigational Site
Irvine, California, 92697
Pfizer Investigational Site
Jacksonville, Florida, 32224
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
Las Vegas, Nevada, 89106
Pfizer Investigational Site
Lexington, Kentucky, 40504
Pfizer Investigational Site
Lexington, Kentucky, 40536
Pfizer Investigational Site
Los Angeles, California, 90033
Pfizer Investigational Site
Los Angeles, California, 90095
Pfizer Investigational Site
Madison, Wisconsin, 53705
Pfizer Investigational Site
Madison, Wisconsin, 53792
Pfizer Investigational Site
Martinez, California, 94553
Pfizer Investigational Site
Miami Beach, Florida, 33140
Pfizer Investigational Site
Nashville, Tennessee, 37208
Pfizer Investigational Site
New Haven, Connecticut, 06509
Pfizer Investigational Site
New Haven, Connecticut, 06510
Pfizer Investigational Site
New Haven, Connecticut, 06520
Pfizer Investigational Site
New York, New York, 10016
Pfizer Investigational Site
New York, New York, 10029
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Newport Beach, California, 92660
Pfizer Investigational Site
North Charleston, South Carolina, 29406-6076
Pfizer Investigational Site
Orange, California, 92868
Pfizer Investigational Site
Palo Alto, California, 94304
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104
Pfizer Investigational Site
Phoenix, Arizona, 85006
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213
Pfizer Investigational Site
Portland, Oregon, 97201
Pfizer Investigational Site
Providence, Rhode Island, 02903
Pfizer Investigational Site
Rochester, New York, 14620
Pfizer Investigational Site
Sacramento, California, 95817
Pfizer Investigational Site
Salt Lake City, Utah, 84108
Pfizer Investigational Site
San Diego, California, 92103-8749
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
San Diego, California, 92128
Pfizer Investigational Site
San Francisco, California, 94117
Pfizer Investigational Site
San Francisco, California, 94121
Pfizer Investigational Site
San Francisco, California, 94143
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
Seattle, Washington, 98108
Pfizer Investigational Site
St Louis, Missouri, 63108
Pfizer Investigational Site
Sun City, Arizona, 85351
Pfizer Investigational Site
Tampa, Florida, 33613
Pfizer Investigational Site
Vista, California, 92081
Pfizer Investigational Site
Washington D.C., District of Columbia, 20007
Pfizer Investigational Site
Washington D.C., District of Columbia, 20057
Pfizer Investigational Site
Washington D.C., District of Columbia, 20060
About this study
Official title: A Double Blind, Placebo Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of Eighteen Months Of Treatment With PF 04494700 (TTP488) In Participants With Mild To Moderate Alzheimer's Disease
The purpose of this study is to evaluate the efficacy and safety of PF 04494700 in participants with mild to moderate Alzheimer's disease.
- Conditions
- Alzheimer's Disease
- Being tested
- PF-04494700, Placebo
- Keywords
- RI RI Study Rage Inhibitors
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04494700Drug
15 mg for 6 days followed by daily dosing of 5mg
PF-04494700Drug
60 mg for 6 days followed by daily dosing of 20mg. Dosing in this arm has been discontinued.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: PF-04494700 |
| 2 | Experimental | Not described Receives: Drug: PF-04494700 |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of PF 04494700 relative to placebo. Change from baseline in a standardized cognitive measure after 18 months of treatment.
Measured: 18 Month
Examine the safety and tolerability of PF 04494700 relative to placebo. Adverse events, vital signs, physical exam, neuro exam, 12-lead ECG, lab tests (hematology, blood chemistry, urinalysis) and brain magnetic resonance imaging (MRI).
Measured: 18 Month
Secondary outcomes (3)
Evaluate the effects of PF 04494700 on potential biomarkers of RAGE inhibition and amyloid imaging (AV-45, F18 PET)
Measured: 18 Month
Evaluate the potential dose response of PF 04494700
Measured: 18 Month
Evaluate the pharmacokinetics and characterize the pharmacokinetic (PK)/ pharmacodynamic (PD) relationship of PF 04494700 to potential biomarkers and relevant efficacy and safety endpoints
Measured: 18 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionDec 2010
- Study completionDec 2010
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.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alzheimer's Disease Cooperative Study (ADCS)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566397
- Sponsor's protocol ID
- B0341002
- Status last verified
- Nov 2018
- First submitted
- 29 Nov 2007
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of Eighteen Months Of Treatment With PF 04494700 (TTP488) In Participants With Mild To Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00566397
- Acronym / sponsor ID
- B0341002
- Conditions
- Alzheimer's Disease
- Keywords
- RI RI Study Rage Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Alzheimer's Disease Cooperative Study (ADCS)
- Study start
- Dec 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Dec 2007 (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 evaluate the efficacy and safety of PF 04494700 in participants with mild to moderate Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PF-04494700 |
| 2 | Experimental | Drug: PF-04494700 |
| 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mini Mental State Exam (MMSE) score between 14-26 (inclusive) at screening.
- Participants must be receiving acetylcholinesterase inhibitors on a stable dose for at least 4 months prior to randomization
Key exclusion criteria (4 listed)
- Current evidence or history of neurological, psychiatric and any other illness that could contribute to non-Alzheimer's dementia.
- Known history of familial AD or any evidence for early onset AD known or possibly associated with genetic mutations.
- Evidence or history of diabetes mellitus Type 1 or Type 2.
- History or symptoms of autoimmune disorders.
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 |
|---|---|---|
| PF-0449470015 mg for 6 days followed by daily dosing of 5mg | Drug | 1 |
| PF-0449470060 mg for 6 days followed by daily dosing of 20mg. Dosing in this arm has been discontinued. | Drug | 2 |
| PlaceboPlacebo | Drug | 3 |
Primary outcome
Evaluate the efficacy of PF 04494700 relative to placebo. Change from baseline in a standardized cognitive measure after 18 months of treatment.
Time frame: 18 Month
Examine the safety and tolerability of PF 04494700 relative to placebo. Adverse events, vital signs, physical exam, neuro exam, 12-lead ECG, lab tests (hematology, blood chemistry, urinalysis) and brain magnetic resonance imaging (MRI).
Time frame: 18 Month
3 secondary outcomes
Evaluate the effects of PF 04494700 on potential biomarkers of RAGE inhibition and amyloid imaging (AV-45, F18 PET)
Time frame: 18 Month
Evaluate the potential dose response of PF 04494700
Time frame: 18 Month
Evaluate the pharmacokinetics and characterize the pharmacokinetic (PK)/ pharmacodynamic (PD) relationship of PF 04494700 to potential biomarkers and relevant efficacy and safety endpoints
Time frame: 18 Month
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 30 Nov 2018.
- 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
62 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-04494700 in people with Alzheimer's Disease, run by Pfizer at 62 sites in United States.
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 4 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 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Evaluate the efficacy of PF 04494700 relative to placebo. Change from baseline in a standardized cognitive measure after 18 months of treatment. (time frame: 18 Month). The study lists 2 primary outcomes in all. 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 30 Nov 2018.