Alzheimer's DiseasePhase 1NCT01005862
Effect of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers
A Phase 1 study testing PF-04360365 in people with Alzheimer's Disease, run by Pfizer at 3 sites in 2 countries.
Trial summary
The primary goal of this study is to evaluate the effect of PF-04360365 on the clearance of ABETA from the CSF (cerebrospinal fluid) in patients with mild Alzheimer's disease and healthy volunteers. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- 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
- 17 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2010to Sep 2012
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females of non-childbearing potential (age 50 and over for Alzheimer's disease patients; 21-45 for healthy volunteers)
- For patients with Alzheimer's Disease: Diagnosis of probable Alzheimer's disease, consistent with criteria from both National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
- Mini-mental status exam score greater than or equal to 20
- Rosen-Modified Hachinski Ischemia Score of < or = 4
- On stable dose of background cholinesterase inhibitor or memantine at least 3 months prior to enrollment
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
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Pfizer Investigational Site
Glendale, California, 91206
Pfizer Investigational Site
St Louis, Missouri, 63110
About this study
Official title: A Randomized, Investigator And Subject-Blind, Sponsor-Open, Placebo-Controlled Study To Examine The Effects Of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers
The primary goal of this study is to evaluate the effect of PF-04360365 on the clearance of ABETA from the CSF (cerebrospinal fluid) in patients with mild Alzheimer's disease and healthy volunteers. Additionally, the study will assess the pharmacokinetics of PF-04360365, pharmacokinetic and pharmacodynamic relationships in plasma and CSF and the safety and tolerability of single doses of PF-04360365 administered to patients with Alzheimer's disease and healthy volunteers.
- Conditions
- Alzheimer's Disease
- Being tested
- PF-04360365, Placebo
- Keywords
- Alzheimer's disease antibody leucine ABeta
- 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
10 mg/kg, single dose administered intravenously
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| PF-04360365 | Experimental | Not described Receives: Biological: PF-04360365 |
| Placebo | Placebo comparator | single dose administered intravenously Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Clearance rate of ABeta peptide in CSF
Measured: 36 hours
Secondary outcomes (4)
Area under the ratio of CSF labeled/unlabeled ABETA time curve from onset of clearance to 36h following start of infusion
Measured: 36 hours
PF-04360365 concentrations and ABETA concentrations in plasma and CSF
Measured: 36 hours
Ratio of labeled/unlabeled leucine in plasma and CSF post labeled leucine administration
Measured: 36 hours
Adverse events, vital signs, clinical labs, electrocardiograms, physical / neurologic examinations, Columbia Suicide Severity Rating Scale, MRI
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 posted2 Nov 2009 (estimated)
- Study startMar 2010
- Primary completionSep 2012
- Study completionSep 2012
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005862
- Sponsor's protocol ID
- A9951011
- Status last verified
- Sep 2012
- First submitted
- 30 Oct 2009
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Investigator And Subject-Blind, Sponsor-Open, Placebo-Controlled Study To Examine The Effects Of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01005862
- Acronym / sponsor ID
- A9951011
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease antibody leucine ABeta
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 2 Nov 2009 (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 primary goal of this study is to evaluate the effect of PF-04360365 on the clearance of ABETA from the CSF (cerebrospinal fluid) in patients with mild Alzheimer's disease and healthy volunteers. Additionally, the study will assess the pharmacokinetics of PF-04360365, pharmacokinetic and pharmacodynamic relationships in plasma and CSF and the safety and tolerability of single doses of PF-04360365 administered to patients with Alzheimer's disease and healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-04360365 | Experimental | Biological: PF-04360365 |
| Placebo | Placebo comparator | Drug: Placebosingle dose administered intravenously |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females of non-childbearing potential (age 50 and over for Alzheimer's disease patients; 21-45 for healthy volunteers)
- For patients with Alzheimer's Disease: Diagnosis of probable Alzheimer's disease, consistent with criteria from both National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
- Mini-mental status exam score greater than or equal to 20
- Rosen-Modified Hachinski Ischemia Score of < or = 4
- On stable dose of background cholinesterase inhibitor or memantine at least 3 months prior to enrollment
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-0436036510 mg/kg, single dose administered intravenously | Biological | PF-04360365 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Fractional Clearance rate of ABeta peptide in CSF
Time frame: 36 hours
4 secondary outcomes
Area under the ratio of CSF labeled/unlabeled ABETA time curve from onset of clearance to 36h following start of infusion
Time frame: 36 hours
PF-04360365 concentrations and ABETA concentrations in plasma and CSF
Time frame: 36 hours
Ratio of labeled/unlabeled leucine in plasma and CSF post labeled leucine administration
Time frame: 36 hours
Adverse events, vital signs, clinical labs, electrocardiograms, physical / neurologic examinations, Columbia Suicide Severity Rating Scale, MRI
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 26 Sep 2012.
- 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 2 countries: 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 3 sites in 2 countries.
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 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 26 Sep 2012. 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, Sweden. 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?
Fractional Clearance rate of ABeta peptide in CSF (time frame: 36 hours). 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 26 Sep 2012.