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Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-04360365 0.1 mg/kg
PF-04360365 0.5 mg/kg
PF-04360365 1 mg/kg
Placebo
PF-04360365 3 mg/kg
PF-04360365 8.5 mg/kg
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, antibody, amyloid

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pivotal Research Center
  • Sun Radiology- for MRI
  • Dedicated Phase 1
  • Neuroscience Consultants, LLC
  • Miami Research Associates
  • MRA Clinical Research
  • Sleep Florida, LLC
  • Alexian Brothers Medical Center
  • Alexian Brothers Neurosciences Institute
  • Stark Pharmacy
  • Vince and Associates Clinical Research
  • Vince and Associates Clinical Research
  • Memory Enhancement Center of America, Inc
  • Central Jersey Radiology
  • Butler Hospital
  • Royal Adelaide Hospital
  • The Queen Elizabeth Hospital and Health Service
  • Heidelberg Repatriation Hospital, Austin Health
  • The McCusker Foundation for Alzheimer's Disease Research
  • ZNA Middelheim / Neurology
  • UZ Antwerpen, Department of Neurology
  • UZ Brussel / Geriatrie
  • U.Z. Gasthuisberg / Neurologie
  • University of British Columbia Hospital, Division of Neurology
  • Parkwood Hospital, Geriatric Medicine
  • Kawartha Regional Memory Clinic
  • Toronto Memory Program
  • Sunnybrook Health Sciences Centre
  • Recherche Clinique de Neurologie
  • Diex Recherche Inc.
  • Seoul National University Bundang Hospital
  • Hanyang University Hospital
  • Samsung Medical Center
  • Korea University Anam Hospital
  • Asan Medical Center
  • Konkuk University Medical Center
  • The Pharmacy Department
  • The Shalbourne Suite
  • Kingshill Research Centre
  • MAC UK Neuroscience Ltd
  • Wellcome Trust Clinical Research Facility
  • Memory Assessment and Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

PF-04360365 0.1 mg/kg

PF-04360365 0.5 mg/kg

PF-04360365 1 mg/kg

Placebo

PF-04360365 3 mg/kg

PF-04360365 8.5 mg/kg

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study medication and up to 6 months after last dose that were absent before treatment or worsened relative to pre-treatment state.
Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities
Number of participants with new clinical findings not evident on the baseline scans, such as brain edema, hemorrhage, encephalitis and other pathology (cerebral/meningeal enhancement, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyperintensities) were assessed from structural MRI. Participants with brain abnormality other than those listed above, assessed using MRI scan, were reported under other abnormality. Baseline was defined as the last assessment prior to the first study drug infusion.
Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)
Brain MRI included gadolinium contrast if investigator determined this was necessary for participant care either based on clinical signs or the non-contrast MRI. This decision was made by the investigator on the basis of change in the clinical examination or in response to a possible abnormality seen on the non-contrast brain MRI. Baseline was defined as the last assessment prior to the first study drug infusion.
Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 on Day 150
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 180
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 on Day 210
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 on Day 390
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 on Day 660
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 on Day 720
Only participants received PF-04360365 were analyzed for this outcome measure.

Secondary Outcome Measures

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion.
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion.
Disability Assessment for Dementia (DAD) Score at Baseline
DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion.
Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19
DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion.
Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x)
Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40)
Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42)
Results are not reported for PF-04360365 0.1, 0.5, 1.0 mg/kg, Placebo (Part A and B) arms because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x)
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40)
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42)
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau)
Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration
Abnormality was defined as concentration either less than lower limit of normal (LLN) or more than upper limit of normal (ULN). Baseline was defined as the last assessment prior to the first study drug infusion
Number of Participants With Serum Anti-Drug Anti Body (ADA)
Serum samples were analyzed for the presence or absence of anti-PF-04360365 antibodies using validated semi-quantitative enzyme linked immunosorbent assay (ELISA). Only participants receiving PF-04360365 were analyzed for this outcome measure.

Full Information

First Posted
July 23, 2008
Last Updated
October 11, 2022
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00722046
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 5, 2008 (Actual)
Primary Completion Date
August 16, 2011 (Actual)
Study Completion Date
August 16, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease, antibody, amyloid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-04360365 0.1 mg/kg
Arm Type
Experimental
Arm Title
PF-04360365 0.5 mg/kg
Arm Type
Experimental
Arm Title
PF-04360365 1 mg/kg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
PF-04360365 3 mg/kg
Arm Type
Experimental
Arm Title
PF-04360365 8.5 mg/kg
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
PF-04360365 0.1 mg/kg
Intervention Description
0.1 mg/kg every 60 days (10 doses total)
Intervention Type
Biological
Intervention Name(s)
PF-04360365 0.5 mg/kg
Intervention Description
0.5 mg/kg every 60 days (10 doses total)
Intervention Type
Biological
Intervention Name(s)
PF-04360365 1 mg/kg
Intervention Description
1 mg/kg every 60 days (10 doses total)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo every 60 days (10 doses total)
Intervention Type
Biological
Intervention Name(s)
PF-04360365 3 mg/kg
Intervention Description
3 mg/kg every 60 days (10 doses total)
Intervention Type
Biological
Intervention Name(s)
PF-04360365 8.5 mg/kg
Intervention Description
8.5 mg/kg every 60 days (10 doses total)
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study medication and up to 6 months after last dose that were absent before treatment or worsened relative to pre-treatment state.
Time Frame
Day 1 up to 6 months after last dose of study medication, assessed up to Month 24
Title
Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities
Description
Number of participants with new clinical findings not evident on the baseline scans, such as brain edema, hemorrhage, encephalitis and other pathology (cerebral/meningeal enhancement, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyperintensities) were assessed from structural MRI. Participants with brain abnormality other than those listed above, assessed using MRI scan, were reported under other abnormality. Baseline was defined as the last assessment prior to the first study drug infusion.
Time Frame
Baseline up to Month 24
Title
Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)
Description
Brain MRI included gadolinium contrast if investigator determined this was necessary for participant care either based on clinical signs or the non-contrast MRI. This decision was made by the investigator on the basis of change in the clinical examination or in response to a possible abnormality seen on the non-contrast brain MRI. Baseline was defined as the last assessment prior to the first study drug infusion.
Time Frame
Baseline up to Month 24
Title
Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
0 Hour on Day 0
Title
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
0 Hour (pre-dose) on Day 1
Title
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
2 Hours on Day 1
Title
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
0 Hour (pre-dose) on Day 60
Title
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
2 Hours on Day 60
Title
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
Day 90
Title
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
0 Hour (pre-dose) on Day 120
Title
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
2 Hours on Day 120
Title
Mean Plasma Concentration of PF-04360365 on Day 150
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
Day 150
Title
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 180
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
0 Hour (pre-dose) on Day 180
Title
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
2 Hours on Day 180
Title
Mean Plasma Concentration of PF-04360365 on Day 210
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
Day 210
Title
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
0 Hour (pre-dose) on Day 240
Title
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
2 Hours on Day 240
Title
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
0 Hour (pre-dose) on Day 300
Title
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
2 Hours on Day 300
Title
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
0 Hour (pre-dose) on Day 360
Title
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
2 Hours on Day 360
Title
Mean Plasma Concentration of PF-04360365 on Day 390
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
Day 390
Title
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
0 Hour (pre-dose) on Day 420
Title
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
2 Hours on Day 420
Title
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
0 Hour (pre-dose) on Day 480
Title
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
2 Hours on Day 480
Title
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
0 Hour (pre-dose) on Day 540
Title
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
2 Hours on Day 540
Title
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
Day 570
Title
Mean Plasma Concentration of PF-04360365 on Day 660
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
Day 660
Title
Mean Plasma Concentration of PF-04360365 on Day 720
Description
Only participants received PF-04360365 were analyzed for this outcome measure.
Time Frame
Day 720
Secondary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline
Description
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion.
Time Frame
Baseline
Title
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19
Description
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion.
Time Frame
Baseline and Month 19
Title
Disability Assessment for Dementia (DAD) Score at Baseline
Description
DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion.
Time Frame
Baseline
Title
Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19
Description
DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion.
Time Frame
Baseline and Month 19
Title
Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x)
Time Frame
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
Title
Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40)
Time Frame
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
Title
Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42)
Description
Results are not reported for PF-04360365 0.1, 0.5, 1.0 mg/kg, Placebo (Part A and B) arms because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
Time Frame
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
Title
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x)
Time Frame
Day 0 (Hour 0), 90, 570
Title
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40)
Time Frame
Day 0 (Hour 0), 90, 570
Title
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42)
Time Frame
Day 0 (Hour 0), 90, 570
Title
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau)
Time Frame
Day 0 (Hour 0), 90, 570
Title
Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration
Description
Abnormality was defined as concentration either less than lower limit of normal (LLN) or more than upper limit of normal (ULN). Baseline was defined as the last assessment prior to the first study drug infusion
Time Frame
Baseline up to Month 24
Title
Number of Participants With Serum Anti-Drug Anti Body (ADA)
Description
Serum samples were analyzed for the presence or absence of anti-PF-04360365 antibodies using validated semi-quantitative enzyme linked immunosorbent assay (ELISA). Only participants receiving PF-04360365 were analyzed for this outcome measure.
Time Frame
Day 1 up to Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pivotal Research Center
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Sun Radiology- for MRI
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Dedicated Phase 1
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Neuroscience Consultants, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
MRA Clinical Research
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Sleep Florida, LLC
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Alexian Brothers Medical Center
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Alexian Brothers Neurosciences Institute
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Stark Pharmacy
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Vince and Associates Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Vince and Associates Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Memory Enhancement Center of America, Inc
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Central Jersey Radiology
City
Oakhurst
State/Province
New Jersey
ZIP/Postal Code
07755
Country
United States
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
The Queen Elizabeth Hospital and Health Service
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Heidelberg Repatriation Hospital, Austin Health
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
The McCusker Foundation for Alzheimer's Disease Research
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
ZNA Middelheim / Neurology
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
UZ Antwerpen, Department of Neurology
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Brussel / Geriatrie
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Facility Name
U.Z. Gasthuisberg / Neurologie
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University of British Columbia Hospital, Division of Neurology
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
Parkwood Hospital, Geriatric Medicine
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
Facility Name
Kawartha Regional Memory Clinic
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9H 2P4
Country
Canada
Facility Name
Toronto Memory Program
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Recherche Clinique de Neurologie
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Diex Recherche Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Hanyang University Hospital
City
Seoul
ZIP/Postal Code
133-792
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
143-914
Country
Korea, Republic of
Facility Name
The Pharmacy Department
City
Cheadle
State/Province
Chesire
ZIP/Postal Code
SK8 2PX
Country
United Kingdom
Facility Name
The Shalbourne Suite
City
Swindon
State/Province
Wiltshire
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Facility Name
Kingshill Research Centre
City
Swindon
State/Province
Wiltshire
ZIP/Postal Code
SN3 6BW
Country
United Kingdom
Facility Name
MAC UK Neuroscience Ltd
City
Manchester
ZIP/Postal Code
M50 2GY
Country
United Kingdom
Facility Name
Wellcome Trust Clinical Research Facility
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Memory Assessment and Research Centre
City
Southampton
ZIP/Postal Code
SO30 3JB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Learn more about this trial

Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease

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