Study Evaluating Bapineuzumab In Alzheimer Disease Subjects

A Phase 2 study testing bapineuzumab in people with Alzheimer Disease, run by Pfizer at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study will evaluate the safety and effectiveness of bapineuzumab for the treatment of mild to moderate Alzheimer disease. Subjects will be in the study for six months and will receive subcutaneous injections once per week. Read more about this study

Who is it for?: Ages 50 to 89 years
Conditions the study is for: Alzheimer Disease
What is being tested?: bapineuzumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 79 participants
Where: 17 sitesUnited States
Study dates: Nov 2008to Oct 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of probable Alzheimer Disease according to National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria
Mini-Mental State Examination (MMSE) score 16-26

Who cannot join

Magnetic Resonance Imaging (MRI) showing other brain abnormalities
Other diagnosed neurological or psychiatric disorders

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Pfizer Investigational Site
Bennington, Vermont, 05201
Pfizer Investigational Site
Dallas, Texas, 75214
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Delray Beach, Florida, 33445
Pfizer Investigational Site
East Providence, Rhode Island, 02914
Pfizer Investigational Site
Encino, California, 91316
Pfizer Investigational Site
Hallandale, Florida, 33009
Pfizer Investigational Site
Lawrenceville, Georgia, 30045
Pfizer Investigational Site
Los Alamitos, California, 90720
Pfizer Investigational Site
Madison, Wisconsin, 53705
Pfizer Investigational Site
Newport Beach, California, 92660
Pfizer Investigational Site
Phoenix, Arizona, 85006
Pfizer Investigational Site
Providence, Rhode Island, 02906
Pfizer Investigational Site
Rochester, New York, 14620
Pfizer Investigational Site
Sun City, Arizona, 85351
Pfizer Investigational Site
West Palm Beach, Florida, 33407
Pfizer Investigational Site
Wichita, Kansas, 67211

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Safety, Tolerability, Reactogenicity, And Pharmacokinetic Study Of Bapineuzumab (AAB 001) Administered Subcutaneously In Subjects With Mild To Moderate AD

Conditions: Alzheimer Disease
Being tested: bapineuzumab, placebo
Keywords: antibody, immunotherapy
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bapineuzumabDrug
5 mg bapineuzumab subcutaneous injection once per week for 6 months
bapineuzumabDrug
10 mg bapineuzumab subcutaneous injection once per week for 6 months
placeboDrug
Placebo subcutaneous injection once per week for 6 months

Study groups in NCT00663026
Study group	Role	What they receive
A	Experimental	5 mg/week Receives: Drug: bapineuzumab
B	Experimental	10 mg/week Receives: Drug: bapineuzumab
C	Experimental	Placebo Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Measured: Baseline up to 30 days after Week 25 dose

Secondary outcomes (6)

Maximum Observed Serum Concentration (Cmax)
Measured: 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
Average Serum Concentration at Steady State (Cavg,ss)
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.
Measured: 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
Serum Decay Half-Life (t1/2)
Serum decay half-life is the time measured for the serum concentration to decrease by one half.
Measured: 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
Time to Reach Maximum Observed Serum Concentration (Tmax)
Measured: 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
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
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.
Measured: 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
Apparent Systemic Clearance (CL/F)
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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Oct 2010

First posted21 Apr 2008 (estimated)
Study startNov 2008
Primary completionOct 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00663026
Sponsor's protocol ID: 3133L1-2203
Other IDs: B2521008
Status last verified: Sep 2013
First submitted: 17 Apr 2008
Last updated: 15 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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ACP-204 in Adults With Alzheimer's Disease Psychosis
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Identification of Diagnosis Biomarkers in the Tears of Alzheimer's Disease Patients: The COG-EYE Pilot Study
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A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
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All Alzheimer Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Safety, Tolerability, Reactogenicity, And Pharmacokinetic Study Of Bapineuzumab (AAB 001) Administered Subcutaneously In Subjects With Mild To Moderate AD
ClinicalTrials.gov ID: NCT00663026
Acronym / sponsor ID: 3133L1-2203
Conditions: Alzheimer Disease
Keywords: antibody, immunotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 21 Apr 2008 (estimated)
Results: Posted 15 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
A	Experimental	Drug: bapineuzumab5 mg/week
B	Experimental	Drug: bapineuzumab10 mg/week
C	Experimental	Drug: placeboPlacebo

Who may qualify

Ages: 50 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis of probable Alzheimer Disease according to National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria
Mini-Mental State Examination (MMSE) score 16-26

Key exclusion criteria (2 listed)

Magnetic Resonance Imaging (MRI) showing other brain abnormalities
Other diagnosed neurological or psychiatric disorders

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
bapineuzumab5 mg bapineuzumab subcutaneous injection once per week for 6 months	Drug	A
bapineuzumab10 mg bapineuzumab subcutaneous injection once per week for 6 months	Drug	B
placeboPlacebo subcutaneous injection once per week for 6 months	Drug	C

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 30 days after Week 25 dose
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.

6 secondary outcomes

Maximum Observed Serum Concentration (Cmax)
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
Average Serum Concentration at Steady State (Cavg,ss)
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
Serum Decay Half-Life (t1/2)
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
Time to Reach Maximum Observed Serum Concentration (Tmax)
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
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
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
Apparent Systemic Clearance (CL/F)
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

Results and safety

Results posted to the registry on 15 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	19	17
Bapineuzumab 5 mg	29	23
Bapineuzumab 10 mg	31	27

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Baseline up to 30 days after Week 25 dose. Number. Unit: participants

Measure	Placebo n = 19	Bapineuzumab 5 mg n = 29	Bapineuzumab 10 mg n = 31
AEs	16	22	28
SAEs	1	2	3

Population analysed: Safety population included all randomized participants who received at least 1 dose of study medication.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 19 (5.3%)	15 of 19 (78.9%)	Not reported
Bapineuzumab 5 mg	2 of 29 (6.9%)	22 of 29 (75.9%)	Not reported
Bapineuzumab 10 mg	3 of 31 (9.7%)	27 of 31 (87.1%)	Not reported

Limitations and caveats (from the sponsor): Designation of outcomes as primary, secondary was based on study team's input as study did not specify them as primary or secondary.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Alzheimer Disease

Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis
Recruiting
Identification of Diagnosis Biomarkers in the Tears of Alzheimer's Disease Patients: The COG-EYE Pilot Study
Alzheimer Disease
Active, not recruitingPhase 2
A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bapineuzumab in people with Alzheimer Disease, run by Pfizer at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to 30 days after Week 25 dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00663026.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2013; AzTrials last refreshed its copy on 6 Nov 2026.