The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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.
Secondary ID [1] 0 0
B2521004
Secondary ID [2] 0 0
3133K1-3003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Reporting a Serious Adverse Event - 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.
Timepoint [1] 0 0
Up to Week 195
Secondary outcome [1] 0 0
Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78 - 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.
Timepoint [1] 0 0
Base Study Baseline, Weeks 13, 26, 39, 52 and 78
Secondary outcome [2] 0 0
Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78. - 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.
Timepoint [2] 0 0
Base Study Baseline, Weeks 13, 26, 39, 52 and 78
Secondary outcome [3] 0 0
Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78. - 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.
Timepoint [3] 0 0
Base Study Baseline, Weeks 13, 26, 39, 52 and 78
Secondary outcome [4] 0 0
Change From Extension Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78. - 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.
Timepoint [4] 0 0
Base Study Baseline, Weeks 13, 26, 39, 52 and 78
Secondary outcome [5] 0 0
Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78. - 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.
Timepoint [5] 0 0
Base Study Baseline, Weeks 26, 52 and 78
Secondary outcome [6] 0 0
Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78. - 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.
Timepoint [6] 0 0
Base Study Baseline, Weeks 26, 52 and 78
Secondary outcome [7] 0 0
Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78. - 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.
Timepoint [7] 0 0
Base Study Baseline, Weeks 6, 19, 32, 45 and 78
Secondary outcome [8] 0 0
Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78. - 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.
Timepoint [8] 0 0
Base Study Baseline, Weeks 6, 19, 32, 45 and 78

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
Minimum age
51 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Gosford Hospital; Pharmacy Dept - Gosford
Recruitment hospital [2] 0 0
Hornsby Hospital - Hornsby
Recruitment hospital [3] 0 0
Royal Adelaide Memory Trials Centre - Adelaide
Recruitment hospital [4] 0 0
Memory Unit 5C, Department of Neurology - Woodville South
Recruitment hospital [5] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [6] 0 0
Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [7] 0 0
Hollywood Hospital; Pharmacy Dept - Nedlands
Recruitment hospital [8] 0 0
The McCusker Foundation for Alzheimer's Disease Research - Nedlands
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2207 - Hornsby
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Rhode Island
Country [22] 0 0
United States of America
State/province [22] 0 0
South Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos Aires
Country [25] 0 0
Belgium
State/province [25] 0 0
Antwerpen
Country [26] 0 0
Belgium
State/province [26] 0 0
Brugge
Country [27] 0 0
Belgium
State/province [27] 0 0
Brussels
Country [28] 0 0
Belgium
State/province [28] 0 0
Leuven
Country [29] 0 0
Belgium
State/province [29] 0 0
Roeselare
Country [30] 0 0
Chile
State/province [30] 0 0
Santiago
Country [31] 0 0
Finland
State/province [31] 0 0
Kuopio
Country [32] 0 0
Finland
State/province [32] 0 0
Turku
Country [33] 0 0
France
State/province [33] 0 0
Bordeaux
Country [34] 0 0
France
State/province [34] 0 0
Bron
Country [35] 0 0
France
State/province [35] 0 0
Caen
Country [36] 0 0
France
State/province [36] 0 0
Colmar
Country [37] 0 0
France
State/province [37] 0 0
Dijon
Country [38] 0 0
France
State/province [38] 0 0
Lille
Country [39] 0 0
France
State/province [39] 0 0
Marseille cedex 5
Country [40] 0 0
France
State/province [40] 0 0
Marseille
Country [41] 0 0
France
State/province [41] 0 0
Montpellier
Country [42] 0 0
France
State/province [42] 0 0
Nantes - Saint Herblain
Country [43] 0 0
France
State/province [43] 0 0
Nice
Country [44] 0 0
France
State/province [44] 0 0
Paris
Country [45] 0 0
France
State/province [45] 0 0
Poitiers
Country [46] 0 0
France
State/province [46] 0 0
Reims
Country [47] 0 0
France
State/province [47] 0 0
Rennes Cedex 9
Country [48] 0 0
France
State/province [48] 0 0
Rennes
Country [49] 0 0
France
State/province [49] 0 0
Rouen Cedex
Country [50] 0 0
France
State/province [50] 0 0
Toulouse
Country [51] 0 0
Italy
State/province [51] 0 0
Ancona
Country [52] 0 0
Italy
State/province [52] 0 0
Catania
Country [53] 0 0
Italy
State/province [53] 0 0
Milano
Country [54] 0 0
Italy
State/province [54] 0 0
Roma
Country [55] 0 0
Japan
State/province [55] 0 0
Aichi,
Country [56] 0 0
Japan
State/province [56] 0 0
Aichi
Country [57] 0 0
Japan
State/province [57] 0 0
Chiba-shi
Country [58] 0 0
Japan
State/province [58] 0 0
Chiba
Country [59] 0 0
Japan
State/province [59] 0 0
Fukuoka
Country [60] 0 0
Japan
State/province [60] 0 0
Gunma
Country [61] 0 0
Japan
State/province [61] 0 0
Hiroshima
Country [62] 0 0
Japan
State/province [62] 0 0
Hyogo
Country [63] 0 0
Japan
State/province [63] 0 0
Kagawa
Country [64] 0 0
Japan
State/province [64] 0 0
Kanagawa
Country [65] 0 0
Japan
State/province [65] 0 0
Kyoto
Country [66] 0 0
Japan
State/province [66] 0 0
Nagano
Country [67] 0 0
Japan
State/province [67] 0 0
Niigata
Country [68] 0 0
Japan
State/province [68] 0 0
Okayama
Country [69] 0 0
Japan
State/province [69] 0 0
Osaka
Country [70] 0 0
Japan
State/province [70] 0 0
Tokyo
Country [71] 0 0
Netherlands
State/province [71] 0 0
's-HERTOGENBOSCH
Country [72] 0 0
Netherlands
State/province [72] 0 0
's-Hertogenbosch
Country [73] 0 0
Netherlands
State/province [73] 0 0
Amsterdam
Country [74] 0 0
Netherlands
State/province [74] 0 0
Leeuwarden
Country [75] 0 0
New Zealand
State/province [75] 0 0
Auckland
Country [76] 0 0
New Zealand
State/province [76] 0 0
Christchurch
Country [77] 0 0
Poland
State/province [77] 0 0
Bydgoszcz
Country [78] 0 0
Poland
State/province [78] 0 0
Poznan
Country [79] 0 0
Poland
State/province [79] 0 0
Warszawa
Country [80] 0 0
Portugal
State/province [80] 0 0
Lisboa
Country [81] 0 0
Portugal
State/province [81] 0 0
Coimbra
Country [82] 0 0
Slovakia
State/province [82] 0 0
Bratislava
Country [83] 0 0
Slovakia
State/province [83] 0 0
Rimavska Sobota
Country [84] 0 0
South Africa
State/province [84] 0 0
Gauteng
Country [85] 0 0
South Africa
State/province [85] 0 0
Kwa Zulu Natal
Country [86] 0 0
Spain
State/province [86] 0 0
Alicante
Country [87] 0 0
Spain
State/province [87] 0 0
Barcelona
Country [88] 0 0
Spain
State/province [88] 0 0
Caceres
Country [89] 0 0
Spain
State/province [89] 0 0
Islas Baleares
Country [90] 0 0
Spain
State/province [90] 0 0
Burgos
Country [91] 0 0
Spain
State/province [91] 0 0
Madrid
Country [92] 0 0
Spain
State/province [92] 0 0
Murcia
Country [93] 0 0
Sweden
State/province [93] 0 0
Malmo
Country [94] 0 0
Sweden
State/province [94] 0 0
Uppsala
Country [95] 0 0
Switzerland
State/province [95] 0 0
BS
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Sheffield
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Wales
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Bradford
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Brighton
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Glasgow
Country [101] 0 0
United Kingdom
State/province [101] 0 0
London
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Newcastle upon Tyne
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Northampton
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Swindon
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Wakefield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00998764
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00998764