Alzheimer's DiseasePhase 2NCT00112073
AAB-001 in Patients With Mild to Moderate Alzheimer's Disease
A Phase 2 study testing bapineuzumab in people with Alzheimer's Disease, run by JANSSEN Alzheimer Immunotherapy Research & Development, LLC at 26 sites in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of multiple doses of AAB-001 passive immunization in patients with mild to moderate Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's 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
- 234 participants
- Where
- 26 sitesUnited States
- Study dates
- Apr 2005to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of probable AD
- Age from 50 to 85 years
- Rosen Modified Hachinski Ischemic score less than or equal to 4
- Magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
- Fluency in English
- Stable doses of medications
Who cannot join
- Significant neurological disease other than AD
- Major psychiatric disorder
- Significant systemic illness
- History of stroke or seizure
- Weight greater than 120 kg (264 lbs.)
- History of autoimmune disease
Show all 10Show fewer
- Smoking more than 20 cigarettes per day
- Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
- Prior treatment with experimental immunotherapeutics or vaccines for AD
- Presence of pacemakers or foreign metal objects in the eyes, skin, or body
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
University of Michigan Health System, Department of Neurology
Ann Arbor, Michigan, 48109
Clinical Neuroscience Research Associates, Inc.
Bennington, Vermont, 05201
Behavioral Neurology
Boston, Massachusetts, 02115
Rush Presbyterian St. Luke's Medical Center
Chicago, Illinois, 60612
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Brain Matters Research, Inc.
Delray Beach, Florida, 33445
Department of Psychiatry and Behavioral Sciences
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
Department of Neurology - Indiana University Medical Center
Indianapolis, Indiana, 46202
UC Irvine
Irvine, California, 92697
Mayo Clinic - Department of Neurology
Jacksonville, Florida, 32224
The Memory Enhancement Center
Long Branch, New Jersey, 07740
Pharmacology Research Institute
Los Alamitos, California, 90720
Yale University School of Medicine
New Haven, Connecticut, 06510
Sergievsky Center, Columbia University
New York, New York, 10032
Pharmacology Research Institute
Northridge, California, 91324
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Oregon Health and Science University
Portland, Oregon, 97239
Memory and Aging Program, Butler Hospital
Providence, Rhode Island, 02906
Mayo Clinic Department of Neurology - Alzheimer's Disease Research Center
Rochester, Minnesota, 55905
University of Rochester / Monroe Community Hospital
Rochester, New York, 14620
UCSD Shiley-Marcos Alzheimer's Disease Research Center
San Diego, California
Memory & Aging Center, UCSF
San Francisco, California
University of Washington
Seattle, Washington, 98108
Cleo Roberts Center for Clinical Research / Sun Health Research Institute
Sun City, Arizona, 85351
Georgetown University Medical Center
Washington D.C., District of Columbia, 20057
About this study
Official title: A Phase IIA, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Immunogenicity Trial of AAB-001 in Patients With Mild to Moderate AD
The purpose of this study is to assess the safety and tolerability of multiple doses of AAB-001 passive immunization in patients with mild to moderate Alzheimer's disease (AD).
Read the detailed description
The humanized monoclonal antibody, AAB-001, which binds to and clears beta amyloid peptide, is designed to provide antibodies to beta amyloid directly to the patient, rather than requiring the patient to mount his/her own individual response. It is believed that this approach may eliminate the need for the patient to mount an immune response to beta amyloid. Animal studies have shown that this approach is equally effective in clearing beta amyloid from the brain as traditional active immunization methods.
This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple ascending dose study in male and female patients aged 50 to 85 years with mild to moderate AD. Approximately 30 study sites will be involved. Patients will be randomized to receive either AAB-001 or placebo. Each patient's participation will last approximately 2 years.
- Conditions
- Alzheimer's Disease
- Being tested
- bapineuzumab, placebo
- Keywords
- Alzheimer's disease, immunotherapy, beta amyloid
- Medical subject headings
- Alzheimer Disease, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bapineuzumabDrug
Also called AAB-001
IV, Q13w
placeboOther
IV Q13w
| Study group | Role | What they receive |
|---|---|---|
| 0.15 mg/kg active bapineuzumab | Experimental | Not described Receives: Drug: bapineuzumab |
| 0.15 mg/kg placebo | Placebo comparator | Not described Receives: Other: placebo |
| 0.5 mg/kg active bapineuzumab | Experimental | Not described Receives: Drug: bapineuzumab |
| 0.5 mg/kg placebo | Placebo comparator | Not described Receives: Other: placebo |
| 1.0 mg/kg active bapineuzumab | Experimental | Not described Receives: Drug: bapineuzumab |
| 1.0 mg/kg placebo | Placebo comparator | Not described Receives: Other: placebo |
| 2.0 mg/kg active bapineuzumab | Experimental | Not described Receives: Drug: bapineuzumab |
| 2.0 mg/kg placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety assessments
Measured: 18 months
Secondary outcomes (2)
blood levels of administered study drug
Measured: 18 months
cognitive and functional assessments
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2005 (estimated)
- Study startApr 2005
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- JANSSEN Alzheimer Immunotherapy Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112073
- Sponsor's protocol ID
- AAB-001-201
- Status last verified
- Mar 2012
- First submitted
- 27 May 2005
- Last updated
- 14 Mar 2012
- Results posted
- No
Publications
Arrighi HM, Barakos J, Barkhof F, Tampieri D, Jack C Jr, Melancon D, Morris K, Ketter N, Liu E, Brashear HR. Amyloid-related imaging abnormalities-haemosiderin (ARIA-H) in patients with Alzheimer's disease treated with bapineuzumab: a historical, prospective secondary analysis. J Neurol Neurosurg Psychiatry. 2016 Jan;87(1):106-12. doi: 10.1136/jnnp-2014-309493. Epub 2015 Feb 10.
PubMed 25669746Blennow K, Zetterberg H, Rinne JO, Salloway S, Wei J, Black R, Grundman M, Liu E; AAB-001 201/202 Investigators. Effect of immunotherapy with bapineuzumab on cerebrospinal fluid biomarker levels in patients with mild to moderate Alzheimer disease. Arch Neurol. 2012 Aug;69(8):1002-10. doi: 10.1001/archneurol.2012.90.
PubMed 22473769
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIA, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Immunogenicity Trial of AAB-001 in Patients With Mild to Moderate AD
- ClinicalTrials.gov ID
- NCT00112073
- Acronym / sponsor ID
- AAB-001-201
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, immunotherapy, beta amyloid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- JANSSEN Alzheimer Immunotherapy Research & Development, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Apr 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 30 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of multiple doses of AAB-001 passive immunization in patients with mild to moderate Alzheimer's disease (AD).
Detailed description
The humanized monoclonal antibody, AAB-001, which binds to and clears beta amyloid peptide, is designed to provide antibodies to beta amyloid directly to the patient, rather than requiring the patient to mount his/her own individual response. It is believed that this approach may eliminate the need for the patient to mount an immune response to beta amyloid. Animal studies have shown that this approach is equally effective in clearing beta amyloid from the brain as traditional active immunization methods.
This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple ascending dose study in male and female patients aged 50 to 85 years with mild to moderate AD. Approximately 30 study sites will be involved. Patients will be randomized to receive either AAB-001 or placebo. Each patient's participation will last approximately 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 0.15 mg/kg active bapineuzumab | Experimental | Drug: bapineuzumab |
| 0.15 mg/kg placebo | Placebo comparator | Other: placebo |
| 0.5 mg/kg active bapineuzumab | Experimental | Drug: bapineuzumab |
| 0.5 mg/kg placebo | Placebo comparator | Other: placebo |
| 1.0 mg/kg active bapineuzumab | Experimental | Drug: bapineuzumab |
| 1.0 mg/kg placebo | Placebo comparator | Other: placebo |
| 2.0 mg/kg active bapineuzumab | Experimental | Drug: bapineuzumab |
| 2.0 mg/kg placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of probable AD
- Age from 50 to 85 years
- Rosen Modified Hachinski Ischemic score less than or equal to 4
- Magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
- Fluency in English
Key exclusion criteria (10 listed)
- Significant neurological disease other than AD
- Major psychiatric disorder
- Significant systemic illness
- History of stroke or seizure
- Weight greater than 120 kg (264 lbs.)
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 |
|---|---|---|
| bapineuzumabAlso: AAB-001IV, Q13w | Drug | 0.15 mg/kg active bapineuzumab, 0.5 mg/kg active bapineuzumab, 1.0 mg/kg active bapineuzumab, 2.0 mg/kg active bapineuzumab |
| placeboIV Q13w | Other | 0.15 mg/kg placebo, 0.5 mg/kg placebo, 1.0 mg/kg placebo, 2.0 mg/kg placebo |
Primary outcome
safety assessments
Time frame: 18 months
2 secondary outcomes
blood levels of administered study drug
Time frame: 18 months
cognitive and functional assessments
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2012.
- Derived from this study: PubMed 25669746Arrighi HM, Barakos J, Barkhof F, Tampieri D, Jack C Jr, Melancon D, Morris K, Ketter N, Liu E, Brashear HR. Amyloid-related imaging abnormalities-haemosiderin (ARIA-H) in patients with Alzheimer's disease treated with bapineuzumab: a historical, prospective secondary analysis. J Neurol Neurosurg Psychiatry. 2016 Jan;87(1):106-12. doi: 10.1136/jnnp-2014-309493. Epub 2015 Feb 10.
- Derived from this study: PubMed 22473769Blennow K, Zetterberg H, Rinne JO, Salloway S, Wei J, Black R, Grundman M, Liu E; AAB-001 201/202 Investigators. Effect of immunotherapy with bapineuzumab on cerebrospinal fluid biomarker levels in patients with mild to moderate Alzheimer disease. Arch Neurol. 2012 Aug;69(8):1002-10. doi: 10.1001/archneurol.2012.90.
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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.
The record lists no contact. Use the official record to reach the sponsor.
26 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's Disease, run by JANSSEN Alzheimer Immunotherapy Research & Development, LLC at 26 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 6 inclusion and 10 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 14 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
safety assessments (time frame: 18 months). 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 NCT00112073, which also lists 2 linked publications.
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 14 Mar 2012.