Clinical trial NCT01369225: Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease
Official title: A Multicenter, Open-label Extension, Multiple Dose, Parallel Group Study To Investigate The Long-term Safety And Tolerability Of Aab-003 (Pf-05236812) Administered Intravenously In Subjects With Mild To Moderate Alzheimer's Disease Previously Treated With Aab-003 Or Placebo In Protocol B2601001
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Randomized
Safety Study
Open Label
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
First posted: 2011-06-08
Enrollment: 52
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the safety and tolerability of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients who complete study B2601001 may participate in this trial and receive AAB-003 (PF-05236812). Each patient's participation will last approximately 52 weeks.


Eligibility criteria: Inclusion Criteria:

* Successful completion of study B2601001
* MMSE 12 or greater

Exclusion Criteria:

* Study B2601001 Week 32 MRI with clinically important exclusionary findings.
* Experienced SAE, vasogenic edema and/or intracranial hemorrhage in study B2601001

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 52
measure: Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern
timeFrame: Baseline up to Week 52
measure: Number of Participants With Potentially Clinically Important Vital Sign Findings
timeFrame: Baseline up to Week 52
measure: Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings
timeFrame: Baseline up to Week 52
measure: Number of Participants With Abnormal Physical Examination Findings
timeFrame: Baseline up to Week 52
measure: Number of Participants With Abnormal Neurological Examination Findings
timeFrame: Baseline up to Week 52
measure: Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline up to Week 52
measure: Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings
timeFrame: Baseline up to Week 52
Secondary outcomes:
Other outcomes:
measure: Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer
timeFrame: Baseline, Week 52
measure: Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52
timeFrame: Baseline, Week 52
Locations:
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Ocala
country: United States
facility: Munroe Regional Medical Center
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Ocala
country: United States
facility: Trinity Care Solutions
state: Florida
city: Ocala
country: United States
facility: Advanced Imaging of Ocala
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Bethesda
country: United States
facility: Foers Medical Arts Pharmacy
state: Maryland
city: Rockville
country: United States
facility: CBH Health, LLC
state: Maryland
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Research Institute
state: Michigan
city: Kalamazoo
country: United States
facility: KNI Southwest Michigan Imaging Center, LLC
state: Michigan
city: Creve Coeur
country: United States
facility: Millennium Psychiatric Associates, LLC
state: Missouri
city: St. Louis
country: United States
facility: DePaul Health Center-MRI Department
state: Missouri
city: Eatontown
country: United States
facility: Memory Enhancement Center of America, Inc.
state: New Jersey
city: Oakhurst
country: United States
facility: Central Jersey Radiology
state: New Jersey
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Hospital, Department Neurology
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital, Department of Neurology
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Department of Neurology
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital IRB
city: Seoul
country: Korea, Republic of
facility: ASAN Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center, Department of Neurology
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Delnomdedieu M, Duvvuri S, Li DJ, Atassi N, Lu M, Brashear HR, Liu E, Ness S, Kupiec JW. First-In-Human safety and long-term exposure data for AAB-003 (PF-05236812) and biomarkers after intravenous infusions of escalating doses in patients with mild to moderate Alzheimer's disease. Alzheimers Res Ther. 2016 Mar 1;8(1):12. doi: 10.1186/s13195-016-0177-y.