search
Back to results

Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AAB-003 (PF-05236812)
AAB-003 (PF-05236812)
AAB-003 (PF-05236812)
AAB-003 (PF-05236812)
AAB-003 (PF-05236812)
Placebo
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 Randomized, Safety Study, Adaptive, Double Blind

Eligibility Criteria

50 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's Disease with MMSE score of 16-26, and brain MRI consistent with the diagnosis of Alzheimer's Disease
  • Concurrent use of cholinesterase inhibitor or memantine allowed, if stable.
  • Caregiver will participate and be able to attend clinic visits with patient

Exclusion Criteria:

  • Significant neurological disease other than Alzheimer's Disease
  • Major psychiatric disorder
  • Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)
  • Women of childbearing potential

Sites / Locations

  • Early Phase Investigational Center
  • Synergy Clinical Research Center of Escondido
  • MD Clinical
  • Franck's Pharmacy
  • Munroe Regional Medical Center
  • Renstar Medical Research
  • Advanced Imaging of Ocala
  • Atlanta Center for Medical Research
  • Foers Medical Arts Pharmacy
  • CBH Health, LLC
  • Borgess Medical Center
  • Borgess Research Institute
  • KNI/Southwest Michigan Imaging Center, LLC
  • Brentwood Behavioral Healthcare
  • Marty's Pharmacy
  • Precise Research Centers
  • Millennium Psychiatric Associates, LLC
  • DePaul Health Center
  • Memory Enhancement Center of America, Inc.
  • Pharmacare USA
  • Central Jersey Radiology
  • Belmont Center for Comprehensive Treatment
  • Albert Einstein Medical Center
  • Seoul National University Bundang Hospital, Department of Neurology
  • Inha University Hospital, Department of Neurology
  • Samsung Medical Center, Department of Neurology
  • Korea University Anam Hospital
  • ASAN Medical Center
  • Konkuk University Medical Center, Department of Neurology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

0.5 mg/kg AAB-003

1 mg/kg AAB-003

2 mg/kg AAB-003

4 mg/kg AAB-003

8 mg/kg AAB-003

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Number of Participants With Laboratory Abnormalities
Number of Participants With Vital Signs of Potential Clinical Concern
Criteria for potential clinical concern in vital signs included: supine/sitting pulse rate of less than (<) 40 or more than (>) 120 beats per minute (bpm), and standing pulse rate of <40 or >140 bpm; systolic blood pressure (SBP) of more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture and <90 mm Hg; diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture and <50 mm Hg. Only supine vital signs were planned for this study. Unplanned sitting vital signs were collected only in the 8/mg and placebo groups and also reported.
Number of Participants With Abnormal Physical Examination Findings
Number of Participants With Abnormal Neurological Examination Findings
The neurological examination was done to the extent needed to assess the participant for any potential changes in neurological status, as determined by the investigator. The minimum items assessed were level of consciousness, speech, cranial nerves, motor, sensory, coordination, gait, and tendon reflexes.
Maximum Observed Serum Concentration (Cmax) for AAB-003 at Day 1
Maximum Observed Serum Concentration (Cmax) for AAB-003 at at Week 26
Average Concentration (Cavg) for AAB-003 in Serum at Day 1
Average Concentration (Cavg) for AAB-003 in Serum at Week 26
Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Day 1
Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Week 26
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for AAB-003 in Serum at Day 1
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for AAB-003 in Serum at Day 1
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Day 1
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Week 26
Systemic Clearance (CL) for AAB-003 in Serum at Day 1
Systemic Clearance (CL) for AAB-003 in Serum at Week 26
Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Day 1
Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Week 26
Serum Decay Half-Life (t1/2) for AAB-003 at Day 1
Serum Decay Half-Life (t1/2) for AAB-003 at Week 26
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS assessed whether the participant experienced the following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").
Number of Participants With New Occurrence of Brain Magnetic Resonance Imaging (MRI) Finding
Brain MRIs were collected during the course of study to assess for any potential drug-related changes that might have constituted a safety concern for study participants. Findings suggestive of either vasogenic edema (VE) or intracranial hemorrhage represented adverse events of special circumstance and were to be reported immediately.
Number of Participants With Vasogenic Edema of All Severity After Each Infusion Visit
VE of the brain, identified via MRI, was identified as an adverse event of special circumstance.
Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria
Criteria for ECG values of potential clinical concern are: interval between the start of the ECG P wave and the start of the QRS complex corresponding to the time between onset of atrial depolarization and onset of ventricular depolarization (PR): >= 300 milliseconds (msec), and >=25% increase when baseline >=200 msec/ >=50% increase when baseline less than or equal to (<=) 200 msec; time from ECG Q wave to the end of S wave corresponding to ventricular depolarization (QRS): >=200 msec, and >=25% increase when baseline >100 msec/ >=50% increase when baseline <=100 msec; QTc using Fridericia's formula (QTcF) interval: 450 to <480 msec, >=480 msec; QTcF change from baseline: 30 to <60 msec, and >=60 msec.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2010
Last Updated
January 3, 2017
Sponsor
Pfizer
Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT01193608
Brief Title
Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease
Official Title
A Phase 1, Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive, Multiple Ascending Dose Study Of The Safety, Tolerability And Pharmacokinetics Of Aab-003 (Pf-05236812) In Subjects With Mild To Moderate Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a study to evaluate the safety of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients will receive either AAB-003 (PF-05236812) or placebo. Each patient's participation will last approximately 41 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Randomized, Safety Study, Adaptive, Double Blind

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.5 mg/kg AAB-003
Arm Type
Experimental
Arm Title
1 mg/kg AAB-003
Arm Type
Experimental
Arm Title
2 mg/kg AAB-003
Arm Type
Experimental
Arm Title
4 mg/kg AAB-003
Arm Type
Experimental
Arm Title
8 mg/kg AAB-003
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AAB-003 (PF-05236812)
Intervention Description
0.5 mg/kg AAB-003, IV
Intervention Type
Drug
Intervention Name(s)
AAB-003 (PF-05236812)
Intervention Description
1 mg/kg AAB-003, IV
Intervention Type
Drug
Intervention Name(s)
AAB-003 (PF-05236812)
Intervention Description
2 mg/kg AAB-003, IV
Intervention Type
Drug
Intervention Name(s)
AAB-003 (PF-05236812)
Intervention Description
4 mg/kg AAB-003, IV
Intervention Type
Drug
Intervention Name(s)
AAB-003 (PF-05236812)
Intervention Description
8 mg/kg AAB-003, IV
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo, IV
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame
Baseline up to 39 Weeks and at Early Withdrawal
Title
Number of Participants With Laboratory Abnormalities
Time Frame
Baseline up to 39 Weeks and at Early Withdrawal
Title
Number of Participants With Vital Signs of Potential Clinical Concern
Description
Criteria for potential clinical concern in vital signs included: supine/sitting pulse rate of less than (<) 40 or more than (>) 120 beats per minute (bpm), and standing pulse rate of <40 or >140 bpm; systolic blood pressure (SBP) of more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture and <90 mm Hg; diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture and <50 mm Hg. Only supine vital signs were planned for this study. Unplanned sitting vital signs were collected only in the 8/mg and placebo groups and also reported.
Time Frame
Baseline up to 39 Weeks and at Early Withdrawal
Title
Number of Participants With Abnormal Physical Examination Findings
Time Frame
Baseline up to 39 Weeks and at Early Withdrawal
Title
Number of Participants With Abnormal Neurological Examination Findings
Description
The neurological examination was done to the extent needed to assess the participant for any potential changes in neurological status, as determined by the investigator. The minimum items assessed were level of consciousness, speech, cranial nerves, motor, sensory, coordination, gait, and tendon reflexes.
Time Frame
Screening, Day 1 (Baseline) and Weeks 1,6,13,19,26,32, and 39, and at Early Withdrawal
Title
Maximum Observed Serum Concentration (Cmax) for AAB-003 at Day 1
Time Frame
Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Title
Maximum Observed Serum Concentration (Cmax) for AAB-003 at at Week 26
Time Frame
Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Title
Average Concentration (Cavg) for AAB-003 in Serum at Day 1
Time Frame
Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Title
Average Concentration (Cavg) for AAB-003 in Serum at Week 26
Time Frame
Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Title
Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Day 1
Time Frame
Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Title
Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Week 26
Time Frame
Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for AAB-003 in Serum at Day 1
Time Frame
Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for AAB-003 in Serum at Day 1
Time Frame
Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Title
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Day 1
Time Frame
Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Title
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Week 26
Time Frame
Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Title
Systemic Clearance (CL) for AAB-003 in Serum at Day 1
Time Frame
Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Title
Systemic Clearance (CL) for AAB-003 in Serum at Week 26
Time Frame
Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Title
Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Day 1
Time Frame
Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Title
Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Week 26
Time Frame
Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Title
Serum Decay Half-Life (t1/2) for AAB-003 at Day 1
Time Frame
Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Title
Serum Decay Half-Life (t1/2) for AAB-003 at Week 26
Time Frame
Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Title
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
The C-SSRS assessed whether the participant experienced the following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").
Time Frame
Baseline up to Week 39 or Early Withdrawal
Title
Number of Participants With New Occurrence of Brain Magnetic Resonance Imaging (MRI) Finding
Description
Brain MRIs were collected during the course of study to assess for any potential drug-related changes that might have constituted a safety concern for study participants. Findings suggestive of either vasogenic edema (VE) or intracranial hemorrhage represented adverse events of special circumstance and were to be reported immediately.
Time Frame
Baseline up to Week 32.
Title
Number of Participants With Vasogenic Edema of All Severity After Each Infusion Visit
Description
VE of the brain, identified via MRI, was identified as an adverse event of special circumstance.
Time Frame
Day 1, Week 13, and Week 26
Title
Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria
Description
Criteria for ECG values of potential clinical concern are: interval between the start of the ECG P wave and the start of the QRS complex corresponding to the time between onset of atrial depolarization and onset of ventricular depolarization (PR): >= 300 milliseconds (msec), and >=25% increase when baseline >=200 msec/ >=50% increase when baseline less than or equal to (<=) 200 msec; time from ECG Q wave to the end of S wave corresponding to ventricular depolarization (QRS): >=200 msec, and >=25% increase when baseline >100 msec/ >=50% increase when baseline <=100 msec; QTc using Fridericia's formula (QTcF) interval: 450 to <480 msec, >=480 msec; QTcF change from baseline: 30 to <60 msec, and >=60 msec.
Time Frame
Baseline, Weeks 1,13,16,26,39 or Early Withdrawal
Other Pre-specified Outcome Measures:
Title
Number of Participants With Positive Anti-product Antibody Response to AAB-003 in Serum
Description
Human serum anti-drug antibodies (ADA) samples were analyzed for the presence or absence of anti-AAB-003 antibodies by enzyme-linked immunosorbent assay (ELISA) method
Time Frame
Day 1 (predose), Week 13 (predose), Week 26 (predose) and Week 39 or Early Withdrawal
Title
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) Score at Weeks 13, 26 and 39
Description
The ADAS-cog 70 Point is a structured scale (approximately 40 min to complete) that evaluates memory, orientation, attention, reasoning, language and constructional praxis. This study used the 11-item cognitive subscale of the ADAS-Cog with scores ranging from 0 to 70 points; higher scores indicated greater cognitive impairment.
Time Frame
Baseline, Weeks 13, 26 and 39
Title
Change From Baseline in Disability Assessment in Dementia (DAD) Score at Weeks 13, 26 and 39
Description
The DAD is a functional assessment based on an interview with the caregiver that takes approximately 20 min to administer and it is comprised of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. The DAD is scored from 0 to 100 (higher scores indicate better functioning).
Time Frame
Baseline, Weeks 13, 26 and 39
Title
Change From Baseline in Behavioral Symtoms as Measured by the Neuropsychiatric Inventory (NPI) at Weeks 13, 26 and 39
Description
The NPI is an instrument used to assess changes of behavior that have appeared in a defined period of time in participants with Alzheimer's disease (AD) and other dementias. Twelve (12) behavioral areas are assessed in the NPI - delusions, apathy, hallucinations, disinhibition, agitation, irritability, depression, aberrant motor behavior, anxiety, nighttime behaviors, euphoria, appetite, and eating changes. The NPI score is based on frequency and severity of specific behaviors within these categories as reported by the caregiver. A separate caregiver distress score may also be included. The NPI ranges from 0 to 144 (higher scores indicate greater psychopathology).
Time Frame
Baseline, Weeks 13, 26 and 39
Title
Change From Baseline on the Clinical Dementia Rating (CDR) Sum of Boxes (CDR-SB) and Global CDR Rating at Weeks 26 and 39
Description
The CDR scale is a clinician-rated dementia staging instrument that tracks the progression of cognitive impairment in the following 6 categories - memory, orientation, judgment and problem solving, involvement in community affairs, home and hobbies, and personal care based on the CDR interview. The CDR is based on discussions between the clinician with the participant and caregiver using a structured format. A global CDR score is established by clinical scoring rules with values of 0 (no dementia), 0.5 (questionable dementia), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). A more quantitative version of the CDR scale is obtained by summing up the ratings in each of the 6 categories to provide the (CDR-SB). The CDR-SB scale ranges from 0 to 18 where higher score indicates severe dementia.
Time Frame
Baseline, Weeks 26 and 39
Title
Change From Baseline on the Mini Mental State Exam (MMSE) Score at Weeks 13, 26, and 39
Description
The MMSE is a brief 30-point questionnaire test that is used to assess cognition. It is commonly used to screen for dementia. In the time span of about 10 min, it samples various functions, including arithmetic, memory and orientation. Scores range from 0 to 30 (higher scores indicate less impairment) and participants with scores of 16 to 26 were eligible.
Time Frame
Baseline, Weeks 13, 26 and 39
Title
Cerebrospinal Fluid (CSF) Concentration of AAB-003 at Week 32
Description
Participants enrolled in the 2, 4 and 8 mg/kg cohorts participated in an optional CSF collection. Participants enrolled in the maximum tolerated dose (MTD) cohort were mandatorily collected for CSF.
Time Frame
Week 32 or Early Withdrawal
Title
Change From Baseline in CSF Amyloid-beta x-40 Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups
Time Frame
Baseline and Week 32
Title
CSF Amyloid-beta x-40 Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups
Time Frame
Baseline and Week 32
Title
Change From Baseline in CSF Amyloid-beta x-42 Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups
Time Frame
Baseline and Week 32
Title
CSF Amyloid-beta x-42 Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups
Time Frame
Baseline and Week 32
Title
Change From Baseline in CSF Tau Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups
Time Frame
Baseline and Week 32
Title
CSF Tau Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups
Time Frame
Baseline and Week 32
Title
Change From Baseline in CSF P-tau Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups
Time Frame
Baseline and Week 32
Title
CSF P-tau Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups
Time Frame
Baseline and Week 32
Title
Maximum Observed Plasma Concentration (Cmax) for Amyloid-Beta x-40
Time Frame
Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Amyloid-Beta x-40
Time Frame
Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Amyloid-Beta x-40
Time Frame
Baseline; Day 2 (24 hours post start of infusion); Weeks 1, 6, and 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Amyloid-Beta x-40
Time Frame
Baseline; Day 2 (24 hours post start of infusion); Weeks 1, 6, and 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.
Title
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Amyloid-Beta x-40
Time Frame
Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.
Title
Plasma Decay Half-Life (t1/2) for Amyloid-Beta x-40
Time Frame
Baseline; Day 2 (24 hours post start of infusion); Weeks 1, 6, and 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of probable Alzheimer's Disease with MMSE score of 16-26, and brain MRI consistent with the diagnosis of Alzheimer's Disease Concurrent use of cholinesterase inhibitor or memantine allowed, if stable. Caregiver will participate and be able to attend clinic visits with patient Exclusion Criteria: Significant neurological disease other than Alzheimer's Disease Major psychiatric disorder Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body) Women of childbearing potential
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
Early Phase Investigational Center
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Synergy Clinical Research Center of Escondido
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Franck's Pharmacy
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Munroe Regional Medical Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Advanced Imaging of Ocala
City
Ocala
State/Province
Florida
ZIP/Postal Code
34481
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Foers Medical Arts Pharmacy
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
CBH Health, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Borgess Research Institute
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
KNI/Southwest Michigan Imaging Center, LLC
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Brentwood Behavioral Healthcare
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Marty's Pharmacy
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Millennium Psychiatric Associates, LLC
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
DePaul Health Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63044
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
Pharmacare USA
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08837
Country
United States
Facility Name
Central Jersey Radiology
City
Oakhurst
State/Province
New Jersey
ZIP/Postal Code
07755
Country
United States
Facility Name
Belmont Center for Comprehensive Treatment
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131-1689
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Seoul National University Bundang Hospital, Department of Neurology
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Inha University Hospital, Department of Neurology
City
Incheon
Country
Korea, Republic of
Facility Name
Samsung Medical Center, Department of Neurology
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, Department of Neurology
City
Seoul
ZIP/Postal Code
143-914
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26925577
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2601001&StudyName=Study%20Evaluating%20The%20Safety%20Of%20AAB-003%20%28PF-05236812%29%20In%20Subjects%20With%20Alzheimer%27s%20Disease%20
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease

We'll reach out to this number within 24 hrs