Clinical trial NCT00722046: Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease
Official title: A PHASE 2 MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE DOSES OF PF 04360365 IN PATIENTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
antibody
amyloid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-25
Enrollment: 198
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose of the study is to determine whether multiple dose administration of PF-04360365 is safe and well tolerated in patient with mild to moderate Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* Males or females of non childbearing potential, age \> or = 50
* Diagnosis of probable Alzheimer's disease, consistent with criterial from both:

  * National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
  * Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
* Mini-mental status exam score of 16-26 inclusive
* Rosen-Modified Hachinski Ischemia Score of \< or = 4

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: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Day 1 up to 6 months after last dose of study medication, assessed up to Month 24
measure: Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities
timeFrame: Baseline up to Month 24
measure: Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)
timeFrame: Baseline up to Month 24
measure: Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0
timeFrame: 0 Hour on Day 0
measure: Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1
timeFrame: 0 Hour (pre-dose) on Day 1
measure: Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1
timeFrame: 2 Hours on Day 1
measure: Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60
timeFrame: 0 Hour (pre-dose) on Day 60
measure: Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60
timeFrame: 2 Hours on Day 60
measure: Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90
timeFrame: Day 90
measure: Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120
timeFrame: 0 Hour (pre-dose) on Day 120
measure: Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120
timeFrame: 2 Hours on Day 120
measure: Mean Plasma Concentration of PF-04360365 on Day 150
timeFrame: Day 150
measure: Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 180
timeFrame: 0 Hour (pre-dose) on Day 180
measure: Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180
timeFrame: 2 Hours on Day 180
measure: Mean Plasma Concentration of PF-04360365 on Day 210
timeFrame: Day 210
measure: Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240
timeFrame: 0 Hour (pre-dose) on Day 240
measure: Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240
timeFrame: 2 Hours on Day 240
measure: Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300
timeFrame: 0 Hour (pre-dose) on Day 300
measure: Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300
timeFrame: 2 Hours on Day 300
measure: Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360
timeFrame: 0 Hour (pre-dose) on Day 360
measure: Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360
timeFrame: 2 Hours on Day 360
measure: Mean Plasma Concentration of PF-04360365 on Day 390
timeFrame: Day 390
measure: Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420
timeFrame: 0 Hour (pre-dose) on Day 420
measure: Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420
timeFrame: 2 Hours on Day 420
measure: Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480
timeFrame: 0 Hour (pre-dose) on Day 480
measure: Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480
timeFrame: 2 Hours on Day 480
measure: Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540
timeFrame: 0 Hour (pre-dose) on Day 540
measure: Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540
timeFrame: 2 Hours on Day 540
measure: Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570
timeFrame: Day 570
measure: Mean Plasma Concentration of PF-04360365 on Day 660
timeFrame: Day 660
measure: Mean Plasma Concentration of PF-04360365 on Day 720
timeFrame: Day 720
Secondary outcomes:
measure: Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline
timeFrame: Baseline
measure: Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19
timeFrame: Baseline and Month 19
measure: Disability Assessment for Dementia (DAD) Score at Baseline
timeFrame: Baseline
measure: Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19
timeFrame: Baseline and Month 19
measure: Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x)
timeFrame: 0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
measure: Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40)
timeFrame: 0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
measure: Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42)
timeFrame: 0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
measure: Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x)
timeFrame: Day 0 (Hour 0), 90, 570
measure: Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40)
timeFrame: Day 0 (Hour 0), 90, 570
measure: Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42)
timeFrame: Day 0 (Hour 0), 90, 570
measure: Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau)
timeFrame: Day 0 (Hour 0), 90, 570
measure: Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration
timeFrame: Baseline up to Month 24
measure: Number of Participants With Serum Anti-Drug Anti Body (ADA)
timeFrame: Day 1 up to Month 24
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Pivotal Research Center
state: Arizona
city: Peoria
country: United States
facility: Sun Radiology- for MRI
state: Arizona
city: Phoenix
country: United States
facility: Dedicated Phase 1
state: Arizona
city: Miami
country: United States
facility: Neuroscience Consultants, LLC
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: South Miami
country: United States
facility: MRA Clinical Research
state: Florida
city: South Miami
country: United States
facility: Sleep Florida, LLC
state: Florida
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Neurosciences Institute
state: Illinois
city: Overland Park
country: United States
facility: Stark Pharmacy
state: Kansas
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
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: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital and Health Service
state: South Australia
city: Heidelberg West
country: Australia
facility: Heidelberg Repatriation Hospital, Austin Health
state: Victoria
city: Nedlands
country: Australia
facility: The McCusker Foundation for Alzheimer's Disease Research
state: Western Australia
city: Antwerpen
country: Belgium
facility: ZNA Middelheim / Neurology
city: Edegem
country: Belgium
facility: UZ Antwerpen, Department of Neurology
city: Jette
country: Belgium
facility: UZ Brussel / Geriatrie
city: Leuven
country: Belgium
facility: U.Z. Gasthuisberg / Neurologie
city: Vancouver
country: Canada
facility: University of British Columbia Hospital, Division of Neurology
state: British Columbia
city: London
country: Canada
facility: Parkwood Hospital, Geriatric Medicine
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Regional Memory Clinic
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Recherche Clinique de Neurologie
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche Inc.
state: Quebec
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Cheadle
country: United Kingdom
facility: The Pharmacy Department
state: Chesire
city: Swindon
country: United Kingdom
facility: The Shalbourne Suite
state: Wiltshire
city: Swindon
country: United Kingdom
facility: Kingshill Research Centre
state: Wiltshire
city: Manchester
country: United Kingdom
facility: MAC UK Neuroscience Ltd
city: Southampton
country: United Kingdom
facility: Wellcome Trust Clinical Research Facility
city: Southampton
country: United Kingdom
facility: Memory Assessment and Research Centre
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: