Alzheimer's DiseasePhase 1NCT00607308
A Phase I, Single Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease
A Phase 1 study testing PF-04360365 in people with Alzheimer's Disease, run by Pfizer at 9 sites in Japan.
Trial summary
The purpose of this study is to examine the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's Disease. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- PF-04360365
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 9 sitesJapan
- Study dates
- Feb 2008to Oct 2010
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese male or females of non-childbearing potential, ages 50-85
- Diagnosis of probable Alzheimer's disease, consistent with criteria from both: (1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) 2) Text Revision of The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR)
- Mini-Mental Status Exam score of 16-26 inclusive
- Rosen-Modified Hachinski Ischemia score < or = 4
Who cannot join
- Diagnosis or history of other dementia 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
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
Pfizer Investigational Site
Bunkyo-ku, Tokyo
Pfizer Investigational Site
Fukuoka, Fukuoka
Pfizer Investigational Site
Fukuyama, Hiroshima
Pfizer Investigational Site
Hirosaki, Aomori
Pfizer Investigational Site
Kanazawa, Kanazawa
Pfizer Investigational Site
Kodaira, Tokyo
Pfizer Investigational Site
Kyoto, Kyoto
Pfizer Investigational Site
Niigata, Niigata
Pfizer Investigational Site
Tsukuba, Ibaraki
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Double Blind, Dose-Escalation, Multicenter Study Of The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Immunogenicity Of A Single Intravenous Dose Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease
The purpose of this study is to examine the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's Disease.
- Conditions
- Alzheimer's Disease
- Being tested
- PF-04360365, Placebo
- 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-04360365Biological
Single dose of 0.1 mg/kg IV on Day 1
PF-04360365Biological
Single dose of 0.5 mg/kg IV on Day 1
PF-04360365Biological
Single dose of 1 mg/kg IV on Day 1
PF-04360365Biological
Single dose of 5 mg/kg IV on Day 1
PlaceboDrug
Single dose of placebo IV on Day 1
PF-04360365Biological
Single dose of 10 mg/kg IV on Day 1
| Study group | Role | What they receive |
|---|---|---|
| 0.1 mg/kg | Experimental | Not described Receives: Biological: PF-04360365 |
| 0.5 mg/kg | Experimental | Not described Receives: Biological: PF-04360365 |
| 1 mg/kg | Experimental | Not described Receives: Biological: PF-04360365 |
| 5 mg/kg | Experimental | Not described Receives: Biological: PF-04360365 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| 10 mg/kg | Experimental | Not described Receives: Biological: PF-04360365 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the safety and tolerability of a single dose of PF-04360365 in Japanese subjects with mild to moderate AD for one year following dosing.
Measured: 1 year
Secondary outcomes (1)
To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 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
- NCT00607308
- Sponsor's protocol ID
- A9951005
- Status last verified
- Dec 2010
- First submitted
- 22 Jan 2008
- Last updated
- 7 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Miyoshi I, Fujimoto Y, Yamada M, Abe S, Zhao Q, Cronenberger C, Togo K, Ishibashi T, Bednar MM, Kupiec JW, Binneman B. Safety and pharmacokinetics of PF-04360365 following a single-dose intravenous infusion in Japanese subjects with mild-to-moderate Alzheimer's disease: a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study. Int J Clin Pharmacol Ther. 2013 Dec;51(12):911-23. doi: 10.5414/CP201816.
PubMed 24131736
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Double Blind, Dose-Escalation, Multicenter Study Of The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Immunogenicity Of A Single Intravenous Dose Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00607308
- Acronym / sponsor ID
- A9951005
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 5 Feb 2008 (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 examine the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 0.1 mg/kg | Experimental | Biological: PF-04360365 |
| 0.5 mg/kg | Experimental | Biological: PF-04360365 |
| 1 mg/kg | Experimental | Biological: PF-04360365 |
| 5 mg/kg | Experimental | Biological: PF-04360365 |
| Placebo | Placebo comparator | Drug: Placebo |
| 10 mg/kg | Experimental | Biological: PF-04360365 |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Japanese male or females of non-childbearing potential, ages 50-85
- Diagnosis of probable Alzheimer's disease, consistent with criteria from both: (1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) 2) Text Revision of The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR)
- Mini-Mental Status Exam score of 16-26 inclusive
- Rosen-Modified Hachinski Ischemia score < or = 4
Key exclusion criteria (5 listed)
- Diagnosis or history of other dementia 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-04360365Single dose of 0.1 mg/kg IV on Day 1 | Biological | 0.1 mg/kg |
| PF-04360365Single dose of 0.5 mg/kg IV on Day 1 | Biological | 0.5 mg/kg |
| PF-04360365Single dose of 1 mg/kg IV on Day 1 | Biological | 1 mg/kg |
| PF-04360365Single dose of 5 mg/kg IV on Day 1 | Biological | 5 mg/kg |
| PlaceboSingle dose of placebo IV on Day 1 | Drug | Placebo |
| PF-04360365Single dose of 10 mg/kg IV on Day 1 | Biological | 10 mg/kg |
Primary outcome
To examine the safety and tolerability of a single dose of PF-04360365 in Japanese subjects with mild to moderate AD for one year following dosing.
Time frame: 1 year
1 secondary outcome
To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing.
Time frame: 1 year
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 7 Dec 2010.
- Derived from this study: PubMed 24131736Miyoshi I, Fujimoto Y, Yamada M, Abe S, Zhao Q, Cronenberger C, Togo K, Ishibashi T, Bednar MM, Kupiec JW, Binneman B. Safety and pharmacokinetics of PF-04360365 following a single-dose intravenous infusion in Japanese subjects with mild-to-moderate Alzheimer's disease: a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study. Int J Clin Pharmacol Ther. 2013 Dec;51(12):911-23. doi: 10.5414/CP201816.
- 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
9 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 in people with Alzheimer's Disease, run by Pfizer at 9 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 4 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 7 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
To examine the safety and tolerability of a single dose of PF-04360365 in Japanese subjects with mild to moderate AD for one year following dosing. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00607308, which also lists 1 linked publication.
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 7 Dec 2010.