Alzheimer's DiseasePhase 1NCT00733642
Single Dose Escalation Study of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease
A Phase 1 study testing PF-04360365 1 mg/kg, PF-04360365 3 mg/kg and PF-04360365 5 mg/kg in people with Alzheimer's Disease, run by Pfizer at 3 sites in United States.
Trial summary
The purpose of this study is to determine whether single doses of PF-04360365 is safe and well tolerated in patients with 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-04360365 1 mg/kg, PF-04360365 3 mg/kg and PF-04360365 5 mg/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2008to Jul 2009
- 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
- Male or female (of non-child bearing potential) subjects ages ≥50 years of age.
- Diagnosis of probable AD (of mild to moderate severity), consistent with criteria from both: NINCDS-Alzheimer's Disease and Related Disorders Association (ADRDA) and DSM-IV-TR.
- MMSE score of 16-26 inclusive.
- Rosen-Modified Hachinski Ischemia Score ≤4.
- On a stable dose of background cholinesterase inhibitors or memantine for at least 60 days prior to dosing.
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.
- History of allergic or anaphylactic reactions.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pfizer Investigational Site
Eatontown, New Jersey, 07724
Pfizer Investigational Site
Glendale, California, 91206
Pfizer Investigational Site
Oakhurst, New Jersey, 07755
About this study
Official title: An Open Label, Single Dose Escalation Study Of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease
The purpose of this study is to determine whether single doses of PF-04360365 is safe and well tolerated in patients with Alzheimer's Disease.
- Conditions
- Alzheimer's Disease
- Being tested
- PF-04360365 1 mg/kg, PF-04360365 3 mg/kg, PF-04360365 5 mg/kg, PF-04360365 10 mg/kg
- Keywords
- antibody amyloid Alzheimer's Disease AD
- 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 1 mg/kgBiological
PF-04360365 1 mg/kg infused as a single dose
PF-04360365 3 mg/kgBiological
PF-04360365 3 mg/kg infused as a single dose
PF-04360365 5 mg/kgBiological
PF-04360365 5 mg/kg infused as a single dose
PF-04360365 10 mg/kgBiological
PF-04360365 10 mg/kg infused as a single dose
| Study group | Role | What they receive |
|---|---|---|
| PF-04360365 1 mg/kg | Experimental | Not described Receives: Biological: PF-04360365 1 mg/kg |
| PF-04360365 3 mg/kg | Experimental | Not described Receives: Biological: PF-04360365 3 mg/kg |
| PF-04360365 5 mg/kg | Experimental | Not described Receives: Biological: PF-04360365 5 mg/kg |
| PF-04360365 10 mg/kg | Experimental | Not described Receives: Biological: PF-04360365 10 mg/kg |
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 subjects with mild-to-moderate AD.
Measured: 6 months
Secondary outcomes (2)
To characterize the pharmacokinetic profile of PF-04360365 following administration of an IV infusion in subjects with mild-to-moderate AD.
Measured: 6 months
To evaluate the relationship of PF-04360365 plasma exposure and Aβ plasma exposure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2009
- Study completionJul 2009
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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT00733642
- Sponsor's protocol ID
- A9951008
- Status last verified
- Jul 2009
- First submitted
- 11 Aug 2008
- Last updated
- 28 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Dose Escalation Study Of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00733642
- Acronym / sponsor ID
- A9951008
- Conditions
- Alzheimer's Disease
- Keywords
- antibody amyloid Alzheimer's Disease AD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 13 Aug 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 determine whether single doses of PF-04360365 is safe and well tolerated in patients with Alzheimer's Disease.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PF-04360365 1 mg/kg | Experimental | Biological: PF-04360365 1 mg/kg |
| PF-04360365 3 mg/kg | Experimental | Biological: PF-04360365 3 mg/kg |
| PF-04360365 5 mg/kg | Experimental | Biological: PF-04360365 5 mg/kg |
| PF-04360365 10 mg/kg | Experimental | Biological: PF-04360365 10 mg/kg |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female (of non-child bearing potential) subjects ages ≥50 years of age.
- Diagnosis of probable AD (of mild to moderate severity), consistent with criteria from both: NINCDS-Alzheimer's Disease and Related Disorders Association (ADRDA) and DSM-IV-TR.
- MMSE score of 16-26 inclusive.
- Rosen-Modified Hachinski Ischemia Score ≤4.
- On a stable dose of background cholinesterase inhibitors or memantine for at least 60 days prior to dosing.
Key exclusion criteria (4 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.
- 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 1 mg/kgPF-04360365 1 mg/kg infused as a single dose | Biological | PF-04360365 1 mg/kg |
| PF-04360365 3 mg/kgPF-04360365 3 mg/kg infused as a single dose | Biological | PF-04360365 3 mg/kg |
| PF-04360365 5 mg/kgPF-04360365 5 mg/kg infused as a single dose | Biological | PF-04360365 5 mg/kg |
| PF-04360365 10 mg/kgPF-04360365 10 mg/kg infused as a single dose | Biological | PF-04360365 10 mg/kg |
Primary outcome
To examine the safety and tolerability of a single dose of PF-04360365 in subjects with mild-to-moderate AD.
Time frame: 6 months
2 secondary outcomes
To characterize the pharmacokinetic profile of PF-04360365 following administration of an IV infusion in subjects with mild-to-moderate AD.
Time frame: 6 months
To evaluate the relationship of PF-04360365 plasma exposure and Aβ plasma exposure.
Time frame: 6 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 28 Jul 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
3 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 1 mg/kg, PF-04360365 3 mg/kg and PF-04360365 5 mg/kg in people with Alzheimer's Disease, run by Pfizer at 3 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 5 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 28 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 subjects with mild-to-moderate AD. (time frame: 6 months). 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 28 Jul 2009.