Effect of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01005862
First received: October 30, 2009
Last updated: September 25, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Biological: PF-04360365 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Fractional Clearance rate of ABeta peptide in CSF [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- PF-04360365 concentrations and ABETA concentrations in plasma and CSF [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
- Ratio of labeled/unlabeled leucine in plasma and CSF post labeled leucine administration [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
- Adverse events, vital signs, clinical labs, electrocardiograms, physical / neurologic examinations, Columbia Suicide Severity Rating Scale, MRI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 17 |
| Study Start Date: | March 2010 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PF-04360365 |
Biological: PF-04360365
10 mg/kg, single dose administered intravenously
|
|
Placebo Comparator: Placebo
single dose administered intravenously
|
Drug: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005862
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Glendale, California, United States, 91206 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63110 | |
| Sweden | |
| Pfizer Investigational Site | |
| Stockholm, Sweden, 141 86 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01005862 History of Changes |
| Other Study ID Numbers: | A9951011 |
| Study First Received: | October 30, 2009 |
| Last Updated: | September 25, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Alzheimer's disease antibody leucine ABeta |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013