Alzheimer DiseasePhase 2NCT00141661
A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's Patients
A Phase 2 study testing PF-04494700 - Low Dose Arm and PF-04494700 - High Dose Arm in people with Alzheimer Disease, run by Pfizer at 12 sites in United States.
Trial summary
A 10-week safety and tolerability study of a potential treatment for 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 Disease
- What is being tested?
- PF-04494700 - Low Dose Arm and PF-04494700 - High Dose Arm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 12 sitesUnited States
- Study dates
- Oct 2005to Jun 2006
- 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
- Diagnosis of probably Alzheimer's disease for at least 1 year.
- Mini Mental State Exam (MMSE) score between 12-26 at screening.
- Participants must be receiving a cholinesterase inhibitor and/or memantine for at least 4 months, and on a stable dose for at least 2 months.
Who cannot join
- Current evidence of a neurological or psychiatric illness that could contribute to dementia.
- Living alone.
- Poorly controlled high blood pressure.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Pfizer Investigational Site
Fort Lauderdale, Florida, 33321
Pfizer Investigational Site
Fort Myers, Florida, 33912
Pfizer Investigational Site
Fresno, California, 93720
Pfizer Investigational Site
Hallandale, Florida, 33009
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Largo, Florida, 33773
Pfizer Investigational Site
Memphis, Tennessee, 38119
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
San Francisco, California, 94118
Pfizer Investigational Site
Sun City, Arizona, 85351
Pfizer Investigational Site
West Palm Beach, Florida, 33407
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Phase IIa, Multiple Dose, Multicenter Study in Subjects With Mild to Moderate Dementia of the Alzheimer's Type to Evaluate the Safety and Tolerability of Two 10-Week Dose Regimens of Orally-Administered PF-04494700
A 10-week safety and tolerability study of a potential treatment for mild to moderate Alzheimer's disease.
- Conditions
- Alzheimer Disease
- Being tested
- PF-04494700 - Low Dose Arm, PF-04494700 - High Dose Arm, Placebo Comparator
- Keywords
- Interventional, Alzheimer, Safety and Tolerability
- 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-04494700 - Low Dose ArmDrug
30 mg loading dose for 6 days, followed by 10 mg daily
PF-04494700 - High Dose ArmDrug
60 mg loading dose for 6 days, followed by 20 mg daily
Placebo ComparatorDrug
Matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Arm | Experimental | Not described Receives: Drug: PF-04494700 - Low Dose Arm |
| High Dose Arm | Experimental | Not described Receives: Drug: PF-04494700 - High Dose Arm |
| Placebo Control | Placebo comparator | Not described Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Measures include Adverse Events
Measured: Every Visit
Laboratory Tests
Measured: Every Office Visit
12-Lead Electrocardiogram
Measured: Every Office Visit
24-Hour 12-Lead Serial ECGs
Measured: Baseline, Study End
Secondary outcomes (3)
Surrogate Efficacy Markers in Plasma: A-Beta, C-Reactive Protein, IL-1, IL-6, Isoprostanes, TNF-alpha, TNF-beta
Measured: Baseline, Visit 5, Study End
Cognitive Function Tests: ADAS-Cog, CDR-Sum of Boxes, MMSE, ADCS-ADL
Measured: Screening Visit, Baseline, Study End
Pharmacokinetic Profile
Measured: Baseline and Every Office Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startOct 2005
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer 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
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Trans Tech Pharmaceuticals
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141661
- Sponsor's protocol ID
- B0341008
- Other IDs
- TTP488-201
- Status last verified
- Aug 2009
- First submitted
- 30 Aug 2005
- Last updated
- 20 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Phase IIa, Multiple Dose, Multicenter Study in Subjects With Mild to Moderate Dementia of the Alzheimer's Type to Evaluate the Safety and Tolerability of Two 10-Week Dose Regimens of Orally-Administered PF-04494700
- ClinicalTrials.gov ID
- NCT00141661
- Acronym / sponsor ID
- B0341008
- Conditions
- Alzheimer Disease
- Keywords
- Interventional, Alzheimer, Safety and Tolerability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Trans Tech Pharmaceuticals
- Study start
- Oct 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 1 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.
A 10-week safety and tolerability study of a potential treatment for 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 |
|---|---|---|
| Low Dose Arm | Experimental | Drug: PF-04494700 - Low Dose Arm |
| High Dose Arm | Experimental | Drug: PF-04494700 - High Dose Arm |
| Placebo Control | Placebo comparator | Drug: Placebo Comparator |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of probably Alzheimer's disease for at least 1 year.
- Mini Mental State Exam (MMSE) score between 12-26 at screening.
- Participants must be receiving a cholinesterase inhibitor and/or memantine for at least 4 months, and on a stable dose for at least 2 months.
Key exclusion criteria (3 listed)
- Current evidence of a neurological or psychiatric illness that could contribute to dementia.
- Living alone.
- Poorly controlled high blood pressure.
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-04494700 - Low Dose Arm30 mg loading dose for 6 days, followed by 10 mg daily | Drug | Low Dose Arm |
| PF-04494700 - High Dose Arm60 mg loading dose for 6 days, followed by 20 mg daily | Drug | High Dose Arm |
| Placebo ComparatorMatching placebo. | Drug | Placebo Control |
Primary outcome
Safety Measures include Adverse Events
Time frame: Every Visit
Laboratory Tests
Time frame: Every Office Visit
12-Lead Electrocardiogram
Time frame: Every Office Visit
24-Hour 12-Lead Serial ECGs
Time frame: Baseline, Study End
3 secondary outcomes
Surrogate Efficacy Markers in Plasma: A-Beta, C-Reactive Protein, IL-1, IL-6, Isoprostanes, TNF-alpha, TNF-beta
Time frame: Baseline, Visit 5, Study End
Cognitive Function Tests: ADAS-Cog, CDR-Sum of Boxes, MMSE, ADCS-ADL
Time frame: Screening Visit, Baseline, Study End
Pharmacokinetic Profile
Time frame: Baseline and Every Office Visit
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 20 Aug 2009.
- 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
12 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 - Low Dose Arm and PF-04494700 - High Dose Arm in people with Alzheimer Disease, run by Pfizer at 12 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 3 inclusion and 3 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 20 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Safety Measures include Adverse Events (time frame: Every Visit). The study lists 4 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 20 Aug 2009.