NCT00606476|TerminatedPhase 2DMC

AAB-001 (Bapineuzumab) Open-Label, Long-Term Extension Study in Patients With Mild to Moderate Alzheimer's Disease

A Phase II, Multicenter, Open-Label, Long-Term Treatment Study to Determine the Safety, Tolerability, and Efficacy of Bapineuzumab (AAB-001) in Patients With Alzheimer's Disease Who Participated in Study AAB-001-201 or AAB-001-102

JANSSEN Alzheimer Immunotherapy Research & Development, LLC ClinicalTrials.gov

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1 other identifier

AAB-001-251

Study Type

interventional

Target

194

Locations

1 country

Sites

Timeline

RegisteredFeb 2008

StartedDec 2006

CompletionSep 2012

Brief Summary

This is a multicenter, open-label, long-term extension study in male and female patients with mild to moderate Alzheimer's Disease (AD) who must have completed one of the following studies: AAB-001-201 or AAB-001-102. All patients enrolled in Study AAB-001-251 will receive infusions of AAB-001 (bapineuzumab), including patients randomized to placebo in Study 201 and 102. Approximately 30 study sites in the US will be involved. Each patient's participation may vary from 3 months up to 84 months depending on the date of enrollment in this study. AAB-001 (bapineuzumab) is a humanized monoclonal antibody, which binds to and potentially clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

194

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Dec 2006

Longer than P75 for phase_2

Geographic Reach

1 country

29 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.8 years study duration

Study Start

First participant enrolled

December 1, 2006

Completed

1.1 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2008

Completed

24 days until next milestone

First Posted

Study publicly available on registry

February 4, 2008

Completed

4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed

Last Updated

November 25, 2013

Status Verified

August 1, 2012

Enrollment Period

5.8 years

First QC Date

January 11, 2008

Last Update Submit

October 30, 2013

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

To assess the safety and tolerability of long-term treatment of bapineuzumab in subjects with AD.
* The incidence and severity of treatment-emergent adverse events (TEAEs); * Clinically important changes in safety assessment results (including, as appropriate, vital signs, weight, clinical laboratory tests, electrocardiograms \[ECGs\], brain magnetic resonance imaging \[MRIs\], physical and neurological examinations, and infusion site assessments).
3-84 months

Secondary Outcomes (1)

To evaluate the efficacy of long-term treatment of bapineuzumab in subjects with AD.
3-84 months

Study Arms (3)

1

ACTIVE COMPARATOR

0.15 mg/kg active bapineuzumab

Drug: Bapineuzumab (AAB-001)

2

ACTIVE COMPARATOR

0.5 mg/kg active bapineuzumab

Drug: Bapineuzumab (AAB-001)

3

ACTIVE COMPARATOR

1.0 mg/kg active bapineuzmab

Drug: Bapineuzumab (AAB-001)

Interventions

Bapineuzumab (AAB-001)DRUG

IV q13w

Also known as: AAB-001

123

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

A subject must meet ALL of the following criteria to be considered for enrollment into this study:
Signed and dated written informed consent obtained from the subject and/or the subject's caregiver in accordance with the local regulations.
Subjects must have completed Study 201 Visit 22 (Week 78), or Study 102 Visit 11 (Week 16).
Magnetic resonance imaging scan of sufficient quality for the Radiologist to evaluate subject safety from Study 201 Visit 21 (Week 71), or Study 251 Screening Visit for subjects from Study 102.
Lives at home with appropriate caregiver capable of accompanying the subject on all clinic visits, or community dwelling with caregiver capable of accompanying the subject on all clinic visits and visiting with the subject approximately five times per week for the duration of the study.
In the opinion of the investigator, the subject and the caregiver will be compliant.

You may not qualify if:

ANY one of the following will exclude a subject from being enrolled into the study:
Significant neurological disease other than AD that may affect cognition.
Screening visit brain MRI scan (ie, Study 201 Visit 21 (Week 71), or for Study 102, the Study 251 Screening Visit) indicative of any other significant abnormality including but not limited to multiple microhemorrhages or evidence of a single prior hemorrhage \>1 cm3, multiple lacunar infarcts or evidence of a single prior infarct \>1 cm3, evidence of a cerebral contusion, encephalomalacia, arachnoid cysts, or brain tumors (eg, meningioma) unless approved by the medical monitor.
Current presence of a clinically significant major psychiatric disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) or any clinically significant symptom that could affect the subject's ability to participate in the study.
Current clinically significant systemic illness that is likely to result in deterioration of the subject's condition or affect the subject's safety during the study.
History of clinically evident stroke or history of clinically significant carotid or vertebrobasilar stenosis or plaque.
History of seizures, excluding febrile seizures in childhood.
Weight greater than 120 kg (264 lbs).
History or evidence of any clinically significant autoimmune disease or disorder of the immune system.
Clinically significant infection within the last 30 days (eg, chronic persistent or acute infection).
Treatment with immunosuppressive medications (eg, systemic corticosteroids) within the last 90 days (topical and nasal corticosteroids and inhaled corticosteroids for asthma are permitted) or chemotherapeutic agents for malignancy within the last three years.
Myocardial infarction within the last two years.
History of cancer within the last five years, with the exception of basal cell carcinoma, and nonmetastatic squamous cell carcinoma of the skin.
Other clinically significant abnormality on screening (ie, Study 201 Visit 22 \[Week 78\], or Study 102 Visit 11 \[Week 16\]) physical, neurological, laboratory, or ECG examination (eg, atrial fibrillation) that could compromise the study or be detrimental to the subject.
Hemoglobin less than 11 g/dL at screening (ie, Study 201 Visit 22 \[Week 78\], or Study 102 Visit 11 \[Week16\]).
+7 more criteria

Contact the study team to confirm eligibility.