Clinical trial NCT01005862: Effect of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease antibody leucine ABeta
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-11-01
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility 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

Primary outcomes:
measure: Fractional Clearance rate of ABeta peptide in CSF
timeFrame: 36 hours
Secondary outcomes:
measure: Area under the ratio of CSF labeled/unlabeled ABETA time curve from onset of clearance to 36h following start of infusion
timeFrame: 36 hours
measure: PF-04360365 concentrations and ABETA concentrations in plasma and CSF
timeFrame: 36 hours
measure: Ratio of labeled/unlabeled leucine in plasma and CSF post labeled leucine administration
timeFrame: 36 hours
measure: Adverse events, vital signs, clinical labs, electrocardiograms, physical / neurologic examinations, Columbia Suicide Severity Rating Scale, MRI
timeFrame: 6 months
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: