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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00998764
Registration number
NCT00998764
Ethics application status
Date submitted
16/10/2009
Date registered
20/10/2009
Date last updated
1/01/2016
Titles & IDs
Public title
A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients
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Scientific title
A Phase 3 Extension, Multicenter, Long Term Safety And Tolerability Trial Of Bapineuzumab (Aab 001, Eln115727) In Subjects With Alzheimer Disease Who Are Apolipoprotein E 4 Carriers And Participated In Study 3133k1-3001-us Or Study 3133k1-3001-ww.
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Secondary ID [1]
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B2521004
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Secondary ID [2]
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3133K1-3003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bapineuzumab 0.5 mg/kg
Experimental: Bapineuzumab 0.5 mg/kg -
Treatment: Drugs: Bapineuzumab 0.5 mg/kg
I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Reporting a Serious Adverse Event
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Assessment method [1]
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Safety was measured according to standard adverse event collection as described in the Adverse Event Section of the Results. Complete tables of events are provided there.
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Timepoint [1]
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Up to Week 195
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Secondary outcome [1]
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Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78
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Assessment method [1]
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The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4)constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8 remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.
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Timepoint [1]
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Base Study Baseline, Weeks 13, 26, 39, 52 and 78
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Secondary outcome [2]
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Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.
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Assessment method [2]
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The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4)constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8)remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.
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Timepoint [2]
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Base Study Baseline, Weeks 13, 26, 39, 52 and 78
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Secondary outcome [3]
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Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.
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Assessment method [3]
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The DAD measures instrumental and basic activities of daily living in AD participants. The DAD is administered to the participant's caregiver in the form of an interview. The performance of basic activities of daily living is evaluated in 10 aspects including hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. The caregiver answers 40 questions as yes, no, or not applicable. A one-point score was assigned to each question if the answer is "yes" and a zero score was assigned if the answer is "no". For questions answered as "not applicable", no score will be assigned. The DAD total score was calculated as the total number of questions answered as "yes" divided by the total number of questions answered as "yes" or "no", times 100. The DAD score can range from 0 to 100, with higher scores indicating better function. A positive change indicates improvement from baseline.
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Timepoint [3]
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Base Study Baseline, Weeks 13, 26, 39, 52 and 78
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Secondary outcome [4]
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Change From Extension Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.
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Assessment method [4]
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The DAD measures instrumental and basic activities of daily living in AD participants. The DAD is administered to the participant's caregiver in the form of an interview. The performance of basic activities of daily living is evaluated in 10 aspects including hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. The caregiver answers 40 questions as yes, no, or not applicable. A one-point score was assigned to each question if the answer is "yes" and a zero score was assigned if the answer is "no". For questions answered as "not applicable", no score will be assigned. The DAD total score was calculated as the total number of questions answered as "yes" divided by the total number of questions answered as "yes" or "no", times 100. The DAD score can range from 0 to 100, with higher scores indicating better function. A positive change indicates improvement from baseline.
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Timepoint [4]
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Base Study Baseline, Weeks 13, 26, 39, 52 and 78
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Secondary outcome [5]
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Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.
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Assessment method [5]
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NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/ aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/ indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). The NPI total score ranges from 0 to 144 with higher NPI scores indicate greater impairment. A negative change indicates improvement from baseline.
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Timepoint [5]
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Base Study Baseline, Weeks 26, 52 and 78
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Secondary outcome [6]
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Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.
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Assessment method [6]
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NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/ aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/ indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). The NPI total score ranges from 0 to 144 with higher NPI scores indicate greater impairment. A negative change indicates improvement from baseline.
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Timepoint [6]
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Base Study Baseline, Weeks 26, 52 and 78
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Secondary outcome [7]
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Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.
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Assessment method [7]
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MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. The MMSE total score can range from 0 to 30, with lower scores indicating a greater degree of impairment. A positive change indicates improvement from baseline.
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Timepoint [7]
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Base Study Baseline, Weeks 6, 19, 32, 45 and 78
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Secondary outcome [8]
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Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.
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Assessment method [8]
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MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. The MMSE total score can range from 0 to 30, with lower scores indicating a greater degree of impairment. A positive change indicates improvement from baseline.
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Timepoint [8]
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Base Study Baseline, Weeks 6, 19, 32, 45 and 78
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Eligibility
Key inclusion criteria
- Subject has completed study 3133K1-3001 (Week 78) and brain magnetic resonance imaging
(MRI) scan consistent with the diagnosis of Alzheimer Disease
- Mini-Mental Status Examination (MMSE) >=10 at screening
- Caregiver able to attend all clinic visits with subject
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Minimum age
51
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Any medical or psychiatric contraindication or clinically significant abnormality
that, in the investigator's judgment, will substantially increase the risk associated
with the subject's participation in and completion of the study or could preclude the
evaluation of the subject's response.
- Any significant brain MRI abnormality.
- Use of any investigational drugs or devices, other than bapineuzumab within the last
60 days prior to screening
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2012
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Sample size
Target
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Accrual to date
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Final
494
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Gosford Hospital; Pharmacy Dept - Gosford
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Recruitment hospital [2]
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Hornsby Hospital - Hornsby
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Recruitment hospital [3]
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Royal Adelaide Memory Trials Centre - Adelaide
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Recruitment hospital [4]
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Memory Unit 5C, Department of Neurology - Woodville South
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Recruitment hospital [5]
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The Queen Elizabeth Hospital - Woodville South
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Heidelberg Repatriation Hospital - Heidelberg West
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Recruitment hospital [7]
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Hollywood Hospital; Pharmacy Dept - Nedlands
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Recruitment hospital [8]
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The McCusker Foundation for Alzheimer's Disease Research - Nedlands
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Recruitment postcode(s) [1]
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2250 - Gosford
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Recruitment postcode(s) [2]
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2207 - Hornsby
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Recruitment postcode(s) [3]
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5000 - Adelaide
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5011 - Woodville South
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Recruitment postcode(s) [5]
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3081 - Heidelberg West
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Recruitment postcode(s) [6]
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6009 - Nedlands
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Recruitment outside Australia
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Bradford
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United Kingdom
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Brighton
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United Kingdom
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Glasgow
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Country [101]
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United Kingdom
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State/province [101]
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London
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Country [102]
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United Kingdom
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State/province [102]
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Newcastle upon Tyne
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Country [103]
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United Kingdom
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State/province [103]
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Northampton
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Country [104]
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United Kingdom
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State/province [104]
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Swindon
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Country [105]
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United Kingdom
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Wakefield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab
in subjects with Alzheimer Disease who participated in study 3133K1-3001(NCT00676143). Over
250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each
subject's participation will last approximately 4 years.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00998764
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00998764
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