Alzheimer DiseasePhase 2NCT00916617
Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab
A Phase 2 study testing bapineuzumab in people with Alzheimer Disease, run by Pfizer at 16 sites in United States.
Trial summary
This study will evaluate the safety and tolerability of bapineuzumab when administered by subcutaneous injection. The study is open only to subjects who participated in the preceding double-blind study (3133L1-2203 US). Subjects will receive weekly injections of bapineuzumab for 3 years (156 doses). 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?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 16 sitesUnited States
- Study dates
- Jun 2009to Sep 2012
- 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
- Completed preceding double-blind study (3133L1-2203 US)
- MMSE score > 9.
Who cannot join
- Significant brain MRI abnormalities
- Clinically important psychiatric symptoms
- History of stroke
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
The Memory Clinic
Bennington, Vermont, 05201
Texas Neurology, P.A.
Dallas, Texas, 75214
Neurostudies.net
Decatur, Georgia, 30033
Brain Matters Research
Delray Beach, Florida, 33445
Rhode Island Mood and Memory Research Institute
East Providence, Rhode Island, 02914
Pharmacology Research Institute
Encino, California, 91316
MD Clinical
Hallandale, Florida, 33009
Dekalb Neurology Associates, LLC
Lawrenceville, Georgia, 30045
NeuroStudies.net
Lawrenceville, Georgia, 30046
University of Wisconsin, Department of Surgery
Madison, Wisconsin, 53705
University of Wisconsin
Madison, Wisconsin, 53792
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
Butler Hospital
Providence, Rhode Island, 02906
Monroe Community Hospital
Rochester, New York, 14620
Palm Beach Neurology - Premiere Research Institute
West Palm Beach, Florida, 33407
Clinical Research Institute
Wichita, Kansas, 67207
About this study
Official title: A Multicenter, Open Label, Multiple Dose, Parallel Group Investigation Of The Long-term Safety, Tolerability, Reactogenicity, Pharmacokinetics And Pharmacodynamics Of Aab-001 Administered Subcutaneously In Subjects With Mild To Moderate Alzheimer's Disease
This study will evaluate the safety and tolerability of bapineuzumab when administered by subcutaneous injection. The study is open only to subjects who participated in the preceding double-blind study (3133L1-2203 US). Subjects will receive weekly injections of bapineuzumab for 3 years (156 doses). One dosage level will be included: 5 mg/week. All subjects will receive active treatment (bapineuzumab) and no subjects will receive placebo.
- Conditions
- Alzheimer Disease
- Being tested
- bapineuzumab
- Keywords
- open-label, safety, antibody
- 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/week subcutaneous bapineuzumab
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 5 mg/week Receives: Drug: bapineuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings
A brain Magnetic Resonance Imaging (MRI) was obtained from all participants at Week 13 and quarterly thereafter. Participants were to meet the following criteria: screening brain MRI scan is consistent with the diagnosis of Alzheimer's Disease. Screening diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria. Clinically significant MRIs were identified by the investigator. The number of participants with clinically significant MRIs are tabulated by visit and treatment group.
Measured: Week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, Any visit
Secondary outcomes (1)
Pharmacokinetic Parameters Including Maximal Serum Drug Concentration, Time to Maximal Serum Drug Concentration, and Terminal Half-life of Elimination
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: The study was terminated on August 6, 2012, because 2 large Phase 3 studies showed no clinical benefit. This decision was not based on any new safety concerns.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- JANSSEN Alzheimer Immunotherapy Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916617
- Sponsor's protocol ID
- 3133L1-2204
- Other IDs
- B2521009
- Status last verified
- Apr 2017
- First submitted
- 4 Jun 2009
- Last updated
- 1 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Multiple Dose, Parallel Group Investigation Of The Long-term Safety, Tolerability, Reactogenicity, Pharmacokinetics And Pharmacodynamics Of Aab-001 Administered Subcutaneously In Subjects With Mild To Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00916617
- Acronym / sponsor ID
- 3133L1-2204
- Conditions
- Alzheimer Disease
- Keywords
- open-label, safety, antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated on August 6, 2012, because 2 large Phase 3 studies showed no clinical benefit. This decision was not based on any new safety concerns.
- Enrolment
- 62 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- JANSSEN Alzheimer Immunotherapy Research & Development, LLC
- Study start
- Jun 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 9 Jun 2009 (estimated)
- Results
- Posted 1 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and tolerability of bapineuzumab when administered by subcutaneous injection. The study is open only to subjects who participated in the preceding double-blind study (3133L1-2203 US). Subjects will receive weekly injections of bapineuzumab for 3 years (156 doses). One dosage level will be included: 5 mg/week. All subjects will receive active treatment (bapineuzumab) and no subjects will receive placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bapineuzumab5 mg/week |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of probable Alzheimer disease
- Completed preceding double-blind study (3133L1-2203 US)
- MMSE score > 9.
Key exclusion criteria (3 listed)
- Significant brain MRI abnormalities
- Clinically important psychiatric symptoms
- History of stroke
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/week subcutaneous bapineuzumab | Drug | 1 |
Primary outcome
Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings
Time frame: Week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, Any visit
A brain Magnetic Resonance Imaging (MRI) was obtained from all participants at Week 13 and quarterly thereafter. Participants were to meet the following criteria: screening brain MRI scan is consistent with the diagnosis of Alzheimer's Disease. Screening diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria. Clinically significant MRIs were identified by the investigator. The number of participants with clinically significant MRIs are tabulated by visit and treatment group.
1 secondary outcome
Pharmacokinetic Parameters Including Maximal Serum Drug Concentration, Time to Maximal Serum Drug Concentration, and Terminal Half-life of Elimination
Time frame: 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- 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.
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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
16 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 16 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 1 Jun 2017). 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 Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings (time frame: Week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, Any visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2017.