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Study Evaluating Bapineuzumab In Alzheimer Disease Subjects

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ClinicalTrials.gov Identifier: NCT00663026
Recruitment Status : Completed
First Posted : April 21, 2008
Results First Posted : November 15, 2013
Last Update Posted : November 15, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Alzheimer Disease
Interventions Drug: bapineuzumab
Drug: placebo
Enrollment 79
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Bapineuzumab 5 mg Bapineuzumab 10 mg
Hide Arm/Group Description Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months. Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months. Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
Period Title: Overall Study
Started 19 29 31
Completed 17 23 27
Not Completed 2 6 4
Reason Not Completed
Lost to Follow-up             1             0             0
Other             1             2             0
Adverse Event             0             2             3
Caregiver Request             0             2             0
Withdrawal by Subject             0             0             1
Arm/Group Title Placebo Bapineuzumab 5 mg Bapineuzumab 10 mg Total
Hide Arm/Group Description Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months. Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months. Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months. Total of all reporting groups
Overall Number of Baseline Participants 19 29 31 79
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 29 participants 31 participants 79 participants
76.16  (8.63) 71.28  (8.73) 72.42  (8.83) 72.90  (8.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 29 participants 31 participants 79 participants
Female
8
  42.1%
18
  62.1%
12
  38.7%
38
  48.1%
Male
11
  57.9%
11
  37.9%
19
  61.3%
41
  51.9%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the 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 are events between first dose of study drug and up to 30 days after Week 25 dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Baseline up to 30 days after Week 25 dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Placebo Bapineuzumab 5 mg Bapineuzumab 10 mg
Hide Arm/Group Description:
Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
Overall Number of Participants Analyzed 19 29 31
Measure Type: Number
Unit of Measure: participants
AEs 16 22 28
SAEs 1 2 3
2.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax)
Hide Description [Not Specified]
Time Frame Predose, 4 hours [hrs] postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, time to maximum concentration [tmax], area under the curve [AUC], terminal elimination half-life [t1/2], apparent systemic clearance [CL/F], and apparent volume of distribution [Vz/F]).
Arm/Group Title Bapineuzumab 5 mg Bapineuzumab 10 mg
Hide Arm/Group Description:
Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
Overall Number of Participants Analyzed 29 31
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
4219.97  (945.23) 8012.88  (2793.53)
3.Secondary Outcome
Title Average Serum Concentration at Steady State (Cavg,ss)
Hide Description Average plasma concentration at steady state (Cavg,ss) = AUCtau divided by dosing interval (1 week). AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week.
Time Frame Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Bapineuzumab 5 mg Bapineuzumab 10 mg
Hide Arm/Group Description:
Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
Overall Number of Participants Analyzed 25 29
Mean (Standard Deviation)
Unit of Measure: ng/mL
3123.071  (1074.116) 6912.301  (2149.143)
4.Secondary Outcome
Title Serum Decay Half-Life (t1/2)
Hide Description Serum decay half-life is the time measured for the serum concentration to decrease by one half.
Time Frame Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
t1/2 not calculated due to inadequate characterization of the terminal elimination phase.
Arm/Group Title Bapineuzumab 5 mg Bapineuzumab 10 mg
Hide Arm/Group Description:
Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Time to Reach Maximum Observed Serum Concentration (Tmax)
Hide Description [Not Specified]
Time Frame Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F).
Arm/Group Title Bapineuzumab 5 mg Bapineuzumab 10 mg
Hide Arm/Group Description:
Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
Overall Number of Participants Analyzed 29 31
Median (Full Range)
Unit of Measure: hours
3696.00
(1680.00 to 4368.00)
4200.00
(72.00 to 4368.00)
6.Secondary Outcome
Title Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Hide Description AUCtau is the area under the serum concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week.
Time Frame Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Bapineuzumab 5 mg Bapineuzumab 10 mg
Hide Arm/Group Description:
Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
Overall Number of Participants Analyzed 25 31
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
524675.88  (180451.56) 1161266.63  (361056.04)
7.Secondary Outcome
Title Apparent Systemic Clearance (CL/F)
Hide Description Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction (F) of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Steady-state apparent systemic clearance (CL/F) was calculated as dose/AUC tau.
Time Frame Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Bapineuzumab 5 mg Bapineuzumab 10 mg
Hide Arm/Group Description:
Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
Overall Number of Participants Analyzed 25 29
Mean (Standard Deviation)
Unit of Measure: milliliter/hour/kilogram (mL/hr/kg)
0.16  (0.05) 0.132  (0.069)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Placebo Bapineuzumab 5 mg Bapineuzumab 10 mg
Hide Arm/Group Description Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months. Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months. Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
All-Cause Mortality
Placebo Bapineuzumab 5 mg Bapineuzumab 10 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Bapineuzumab 5 mg Bapineuzumab 10 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/19 (5.26%)   2/29 (6.90%)   3/31 (9.68%) 
Cardiac disorders       
Atrial fibrillation * 1  0/19 (0.00%)  0/29 (0.00%)  1/31 (3.23%) 
Immune system disorders       
Serum sickness * 1  0/19 (0.00%)  1/29 (3.45%)  0/31 (0.00%) 
Infections and infestations       
Lobar pneumonia * 1  1/19 (5.26%)  0/29 (0.00%)  0/31 (0.00%) 
Injury, poisoning and procedural complications       
Subdural hemorrhage * 1  0/19 (0.00%)  0/29 (0.00%)  1/31 (3.23%) 
Nervous system disorders       
Convulsion * 1  0/19 (0.00%)  1/29 (3.45%)  0/31 (0.00%) 
Subarachnoid hemorrhage * 1  0/19 (0.00%)  0/29 (0.00%)  1/31 (3.23%) 
Psychiatric disorders       
Delirium * 1  0/19 (0.00%)  0/29 (0.00%)  1/31 (3.23%) 
Reproductive system and breast disorders       
Cystocele * 1  0/19 (0.00%)  0/29 (0.00%)  1/31 (3.23%) 
Rectocele * 1  0/19 (0.00%)  0/29 (0.00%)  1/31 (3.23%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Bapineuzumab 5 mg Bapineuzumab 10 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/19 (78.95%)   22/29 (75.86%)   27/31 (87.10%) 
Ear and labyrinth disorders       
Tympanic membrane perforation * 1  1/19 (5.26%)  0/29 (0.00%)  0/31 (0.00%) 
Gastrointestinal disorders       
Diarrhoea * 1  2/19 (10.53%)  5/29 (17.24%)  2/31 (6.45%) 
Dyspepsia * 1  1/19 (5.26%)  2/29 (6.90%)  0/31 (0.00%) 
Gastric haemorrhage * 1  1/19 (5.26%)  0/29 (0.00%)  0/31 (0.00%) 
Hiatus hernia * 1  1/19 (5.26%)  0/29 (0.00%)  0/31 (0.00%) 
Nausea * 1  1/19 (5.26%)  2/29 (6.90%)  2/31 (6.45%) 
Rectal haemorrhage * 1  0/19 (0.00%)  0/29 (0.00%)  2/31 (6.45%) 
General disorders       
Fatigue * 1  2/19 (10.53%)  2/29 (6.90%)  0/31 (0.00%) 
Injection site erythema * 1  1/19 (5.26%)  2/29 (6.90%)  1/31 (3.23%) 
Injection site haemorrhage * 1  1/19 (5.26%)  0/29 (0.00%)  0/31 (0.00%) 
Injection site pain * 1  1/19 (5.26%)  0/29 (0.00%)  0/31 (0.00%) 
Vessel puncture site haematoma * 1  1/19 (5.26%)  0/29 (0.00%)  0/31 (0.00%) 
Immune system disorders       
Seasonal allergy * 1  1/19 (5.26%)  0/29 (0.00%)  0/31 (0.00%) 
Infections and infestations       
Nasopharyngitis * 1  2/19 (10.53%)  1/29 (3.45%)  0/31 (0.00%) 
Rhinitis * 1  0/19 (0.00%)  0/29 (0.00%)  2/31 (6.45%) 
Sinusitis * 1  2/19 (10.53%)  0/29 (0.00%)  0/31 (0.00%) 
Upper respiratory tract infection * 1  2/19 (10.53%)  1/29 (3.45%)  6/31 (19.35%) 
Urinary tract infection * 1  2/19 (10.53%)  1/29 (3.45%)  1/31 (3.23%) 
Injury, poisoning and procedural complications       
Arthropod bite * 1  1/19 (5.26%)  0/29 (0.00%)  0/31 (0.00%) 
Contusion * 1  1/19 (5.26%)  3/29 (10.34%)  2/31 (6.45%) 
Fall * 1  0/19 (0.00%)  1/29 (3.45%)  2/31 (6.45%) 
Tendon rupture * 1  1/19 (5.26%)  1/29 (3.45%)  0/31 (0.00%) 
Investigations       
Blood cholesterol increased * 1  1/19 (5.26%)  0/29 (0.00%)  0/31 (0.00%) 
Weight decreased * 1  1/19 (5.26%)  1/29 (3.45%)  1/31 (3.23%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  1/19 (5.26%)  1/29 (3.45%)  0/31 (0.00%) 
Back pain * 1  1/19 (5.26%)  2/29 (6.90%)  1/31 (3.23%) 
Myalgia * 1  1/19 (5.26%)  1/29 (3.45%)  1/31 (3.23%) 
Neck pain * 1  1/19 (5.26%)  0/29 (0.00%)  1/31 (3.23%) 
Osteoarthritis * 1  1/19 (5.26%)  0/29 (0.00%)  0/31 (0.00%) 
Polyarthritis * 1  1/19 (5.26%)  0/29 (0.00%)  0/31 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Atypical fibroxanthoma * 1  1/19 (5.26%)  0/29 (0.00%)  0/31 (0.00%) 
Nervous system disorders       
Dizziness * 1  2/19 (10.53%)  2/29 (6.90%)  2/31 (6.45%) 
Headache * 1  2/19 (10.53%)  2/29 (6.90%)  2/31 (6.45%) 
Paraesthesia * 1  1/19 (5.26%)  0/29 (0.00%)  0/31 (0.00%) 
Somnolence * 1  1/19 (5.26%)  0/29 (0.00%)  0/31 (0.00%) 
Vasogenic cerebral oedema * 1  0/19 (0.00%)  2/29 (6.90%)  6/31 (19.35%) 
Psychiatric disorders       
Agitation * 1  0/19 (0.00%)  2/29 (6.90%)  0/31 (0.00%) 
Anxiety * 1  1/19 (5.26%)  1/29 (3.45%)  1/31 (3.23%) 
Depression * 1  1/19 (5.26%)  0/29 (0.00%)  0/31 (0.00%) 
Hallucination * 1  0/19 (0.00%)  2/29 (6.90%)  0/31 (0.00%) 
Insomnia * 1  0/19 (0.00%)  2/29 (6.90%)  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  2/19 (10.53%)  0/29 (0.00%)  0/31 (0.00%) 
Epistaxis * 1  1/19 (5.26%)  1/29 (3.45%)  0/31 (0.00%) 
Rhinitis allergic * 1  0/19 (0.00%)  0/29 (0.00%)  2/31 (6.45%) 
Skin and subcutaneous tissue disorders       
Psoriasis * 1  1/19 (5.26%)  0/29 (0.00%)  0/31 (0.00%) 
Rash * 1  1/19 (5.26%)  0/29 (0.00%)  0/31 (0.00%) 
Rash papular * 1  1/19 (5.26%)  0/29 (0.00%)  1/31 (3.23%) 
Vascular disorders       
Orthostatic hypotension * 1  1/19 (5.26%)  0/29 (0.00%)  0/31 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v13.0
Designation of outcomes as primary, secondary was based on study team’s input as study did not specify them as primary or secondary.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00663026     History of Changes
Other Study ID Numbers: 3133L1-2203
B2521008
First Submitted: April 17, 2008
First Posted: April 21, 2008
Results First Submitted: September 11, 2013
Results First Posted: November 15, 2013
Last Update Posted: November 15, 2013