Clinical trial NCT00916617: Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab
Official title: A Multicenter, Open Label, Multiple Dose, Parallel Group Investigation Of The Long-term Safety, Tolerability, Reactogenicity, Pharmacokinetics And Pharmacodynamics Of Aab-001 Administered Subcutaneously In Subjects With Mild To Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: open-label
safety
antibody
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
First posted: 2009-06-09
Enrollment: 62
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and tolerability of bapineuzumab when administered by subcutaneous injection. The study is open only to subjects who participated in the preceding double-blind study (3133L1-2203 US). Subjects will receive weekly injections of bapineuzumab for 3 years (156 doses). One dosage level will be included: 5 mg/week. All subjects will receive active treatment (bapineuzumab) and no subjects will receive placebo.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of probable Alzheimer disease
* Completed preceding double-blind study (3133L1-2203 US)
* MMSE score \> 9.

Exclusion Criteria:

* Significant brain MRI abnormalities
* Clinically important psychiatric symptoms
* History of stroke

Primary outcomes:
measure: Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings
timeFrame: Week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, Any visit
Secondary outcomes:
measure: Pharmacokinetic Parameters Including Maximal Serum Drug Concentration, Time to Maximal Serum Drug Concentration, and Terminal Half-life of Elimination
timeFrame: 36 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Neurology - Premiere Research Institute
state: Florida
city: Decatur
country: United States
facility: Neurostudies.net
state: Georgia
city: Lawrenceville
country: United States
facility: Dekalb Neurology Associates, LLC
state: Georgia
city: Lawrenceville
country: United States
facility: NeuroStudies.net
state: Georgia
city: Wichita
country: United States
facility: Clinical Research Institute
state: Kansas
city: Rochester
country: United States
facility: Monroe Community Hospital
state: New York
city: East Providence
country: United States
facility: Rhode Island Mood and Memory Research Institute
state: Rhode Island
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Dallas
country: United States
facility: Texas Neurology, P.A.
state: Texas
city: Bennington
country: United States
facility: The Memory Clinic
state: Vermont
city: Madison
country: United States
facility: University of Wisconsin, Department of Surgery
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: