Alzheimer's DiseasePhase 1NCT01125631
Multiple Intravenous Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease
A Phase 1 study testing PF-04360365 8.5 mg/kg in people with Alzheimer's Disease, run by Pfizer at 4 sites in Japan.
Trial summary
The purpose of the study is to examine the safety and tolerability of a multiple dose of PF-04360365 administered over approximately 10 minutes in Japanese patients with mild-to-moderate Alzheimer's disease and to characterize the pharmacokinetics of PF-04360365 following administration of multiple doses in Japanese… 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-04360365 8.5 mg/kg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 4 sitesJapan
- Study dates
- May 2010to Aug 2011
- Phase
- Phase 1
- 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
- Japanese males or females of non childbearing potential, age > or = 50
- Diagnosis of probable Alzheimer's disease, consistent with criterial from both:
- National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
- Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
- Mini-mental status exam score of 16-26 inclusive
- Rosen-Modified Hachinski Ischemia Score of < or = 4
Who cannot join
- Diagnosis or history of other demential or neurodegenerative disorders
- Diagnosis or history of clinically significant cerebrovascular disease
- Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities
- History of autoimmune disorders
- History of allergic or anaphylactic reactions
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Pfizer Investigational Site
Fukuoka, Fukuoka
Pfizer Investigational Site
Fukuyama, Hiroshima
Pfizer Investigational Site
Hirosaki, Aomori
Pfizer Investigational Site
Kanazawa, Ishikawa-ken
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Double Blind, Multicenter Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenous Doses Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease
The purpose of the study is to examine the safety and tolerability of a multiple dose of PF-04360365 administered over approximately 10 minutes in Japanese patients with mild-to-moderate Alzheimer's disease and to characterize the pharmacokinetics of PF-04360365 following administration of multiple doses in Japanese patients with mild-to-moderate Alzheimer's disease.
- Conditions
- Alzheimer's Disease
- Being tested
- PF-04360365 8.5 mg/kg, Placebo
- Keywords
- Alzheimer's disease, amyloid, antibody, Japanese
- 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-04360365 8.5 mg/kgBiological
8.5 mg/kg every 8 weeks (4 doses total)
PlaceboDrug
Placebo every 8 weeks (4 doses total)
| Study group | Role | What they receive |
|---|---|---|
| PF-04360365 8.5 mg/kg | Experimental | Not described Receives: Biological: PF-04360365 8.5 mg/kg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's disease dosed for 6 months. (adverse events, physical/neurologic exams, vital signs, 12-lead ECG, clinical labs, brain MRI, immunogenicity and cognitive assessments)
Measured: 12 months
Pharmacokinetics of PF-04360365 following administration of multiple doses in Japanese subjects with mild to moderate Alzheimer's disease. (plasma PF-04360365 concentrations)
Measured: 12 months
Secondary outcomes (1)
Plasma concentration of Aβ species following administration of multiple doses of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's disease.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2011
- Study completionAug 2011
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125631
- Sponsor's protocol ID
- A9951016
- Status last verified
- Aug 2011
- First submitted
- 17 May 2010
- Last updated
- 12 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Double Blind, Multicenter Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenous Doses Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01125631
- Acronym / sponsor ID
- A9951016
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, amyloid, antibody, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 18 May 2010 (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 the study is to examine the safety and tolerability of a multiple dose of PF-04360365 administered over approximately 10 minutes in Japanese patients with mild-to-moderate Alzheimer's disease and to characterize the pharmacokinetics of PF-04360365 following administration of multiple doses in Japanese patients 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
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-04360365 8.5 mg/kg | Experimental | Biological: PF-04360365 8.5 mg/kg |
| Placebo | 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 (6 listed)
- Japanese males or females of non childbearing potential, age > or = 50
- Diagnosis of probable Alzheimer's disease, consistent with criterial from both:
- Mini-mental status exam score of 16-26 inclusive
- Rosen-Modified Hachinski Ischemia Score of < or = 4
Key exclusion criteria (5 listed)
- Diagnosis or history of other demential or neurodegenerative disorders
- Diagnosis or history of clinically significant cerebrovascular disease
- Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities
- History of autoimmune disorders
- History of allergic or anaphylactic reactions
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-04360365 8.5 mg/kg8.5 mg/kg every 8 weeks (4 doses total) | Biological | PF-04360365 8.5 mg/kg |
| PlaceboPlacebo every 8 weeks (4 doses total) | Drug | Placebo |
Primary outcome
Safety of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's disease dosed for 6 months. (adverse events, physical/neurologic exams, vital signs, 12-lead ECG, clinical labs, brain MRI, immunogenicity and cognitive assessments)
Time frame: 12 months
Pharmacokinetics of PF-04360365 following administration of multiple doses in Japanese subjects with mild to moderate Alzheimer's disease. (plasma PF-04360365 concentrations)
Time frame: 12 months
1 secondary outcome
Plasma concentration of Aβ species following administration of multiple doses of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's disease.
Time frame: 12 months
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 12 Aug 2011.
- 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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-04360365 8.5 mg/kg in people with Alzheimer's Disease, run by Pfizer at 4 sites in Japan.
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 6 inclusion and 5 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 12 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's disease dosed for 6 months. (adverse events, physical/neurologic exams, vital signs, 12-lead ECG, clinical labs, brain MRI, immunogenicity and cognitive assessments) (time frame: 12 months). 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 12 Aug 2011.