Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B2521003 |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 3133K1-3000 (NCT00667810). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bapineuzumab 0.5 mg/kg | Experimental | bapineuzumab |
|
| Bapineuzumab 1.0 m/kg | Experimental | bapineuzumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bapineuzumab 0.5 mg/kg | Drug | Bapineuzumab I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Week 195 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Hornsby | New South Wales | 2077 | Australia | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27334799 | Derived | Ivanoiu A, Pariente J, Booth K, Lobello K, Luscan G, Hua L, Lucas P, Styren S, Yang L, Li D, Black RS, Brashear HR, McRae T. Long-term safety and tolerability of bapineuzumab in patients with Alzheimer's disease in two phase 3 extension studies. Alzheimers Res Ther. 2016 Jun 23;8(1):24. doi: 10.1186/s13195-016-0193-y. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Participants who had completed the base study protocol 3133K1-3000 were allowed to participate in this extension study. Participants who developed vasogenic edema during study 3133K1-3000 were considered for study 3133K1-3002 participation if the abnormality was resolved and the participant met criteria to resume the investigational product.
This extension study was conducted at 91 centers in 17 countries. The study was terminated early by the sponsor on 06 August 2012. Participants who had not completed the final follow-up visit prior to 06 August 2012 were asked to complete an early termination visit.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Bapineuzumab 0.5 Milligram/Kilogram(mg/kg) | Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| FG001 | Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Bapineuzumab 1.0 m/kg | Drug | I.V., 1.0 mg/kg, infusion every 13 weeks for a total of 16 infusions. |
|
|
| Weeks 13, 26, 39, 52 and 78 |
| 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. | Weeks 13, 26, 39, 52 and 78 |
| 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 participants with Alzheimer's Disease (AD). The DAD is administered to the participants'caregiver in the form of an interview. 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 by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement | Weeks 13, 26, 39, 52 and 78 |
| Change From Extension Study Baseline in DAD Score at Weeks 13, 26, 39, 52 and 78 | The DAD measures instrumental and basic activities of daily living in participants with AD. The DAD is administered to the participants'caregiver in the form of an interview. 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 by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement | Weeks 13, 26, 39, 52 and 78 |
| 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). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement. | Weeks 26, 52 and 78 |
| 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, night-time 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). Total score=sum of each domain score(range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement. | Weeks 26, 52 and 78 |
| 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. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state. | Weeks 6, 19, 32, 45 and 78 |
| 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. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state | Weeks 6, 19, 32, 45 and 78 |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| Pfizer Investigational Site | Woodville South | South Australia | 5011 | Australia |
| Pfizer Investigational Site | Heidelberg Heights | Victoria | 3081 | Australia |
| Pfizer Investigational Site | Nedlands | Western Australia | 6009 | Australia |
| Pfizer Investigational Site | Antwerp | 2020 | Belgium |
| Pfizer Investigational Site | Brussels | 1200 | Belgium |
| Pfizer Investigational Site | Edegem | 2650 | Belgium |
| Pfizer Investigational Site | Santiago | Chile | 7530193 | Chile |
| Pfizer Investigational Site | Santiago | Chile | 7630000 | Chile |
| Pfizer Investigational Site | Kuopio | FIN-70210 | Finland |
| Pfizer Investigational Site | Turku | 20520 | Finland |
| Pfizer Investigational Site | Dijon | France | 21000 | France |
| Pfizer Investigational Site | Lille | France | 59037 | France |
| Pfizer Investigational Site | Marseille | France | 13000 | France |
| Pfizer Investigational Site | Paris | France | 75013 | France |
| Pfizer Investigational Site | Caen | 14033 | France |
| Pfizer Investigational Site | Marseille | 13885 | France |
| Pfizer Investigational Site | Montpellier | 34295 | France |
| Pfizer Investigational Site | Nantes - Saint Herblain | 44093 | France |
| Pfizer Investigational Site | Nice | 06000 | France |
| Pfizer Investigational Site | Poitiers | 86021 | France |
| Pfizer Investigational Site | Rennes | 35000 | France |
| Pfizer Investigational Site | Rouen | 76031 | France |
| Pfizer Investigational Site | Toulouse | 31059 | France |
| Pfizer Investigational Site | Milan | 20133 | Italy |
| Pfizer Investigational Site | Roma | 00179 | Italy |
| Pfizer Investigational Site | Aichi | Japan |
| Pfizer Investigational Site | Chiba | Japan |
| Pfizer Investigational Site | Fukuoka | Japan |
| Pfizer Investigational Site | Hiroshima | Japan |
| Pfizer Investigational Site | Hyōgo | Japan |
| Pfizer Investigational Site | Kagawa | Japan |
| Pfizer Investigational Site | Kanagawa | Japan |
| Pfizer Investigational Site | Kyoto | Japan |
| Pfizer Investigational Site | Nagano | Japan |
| Pfizer Investigational Site | Okayama | Japan |
| Pfizer Investigational Site | Osaka | Japan |
| Pfizer Investigational Site | Shizuoka | Japan |
| Pfizer Investigational Site | Tokyo | Japan |
| Pfizer Investigational Site | 's-Hertogenbosch | 5223 GZ | Netherlands |
| Pfizer Investigational Site | Leeuwarden | 8934 AD | Netherlands |
| Pfizer Investigational Site | North Shore | NZ | 622 | New Zealand |
| Pfizer Investigational Site | Poznan | Poland | 61-289 | Poland |
| Pfizer Investigational Site | Bydgoszcz | 85-796 | Poland |
| Pfizer Investigational Site | Krakow | 31-531 | Poland |
| Pfizer Investigational Site | Warsaw | 01-211 | Poland |
| Pfizer Investigational Site | Warsaw | 02-097 | Poland |
| Pfizer Investigational Site | Amadora | Amadora | 2700-276 | Portugal |
| Pfizer Investigational Site | Coimbra | Coimbra District | 3000-075 | Portugal |
| Pfizer Investigational Site | Lisbon | Lisbon District | 1649-028 | Portugal |
| Pfizer Investigational Site | Bratislava | 825 56 | Slovakia |
| Pfizer Investigational Site | Rimavská Sobota | 979 12 | Slovakia |
| Pfizer Investigational Site | Johannesburg | Gauteng | 2196 | South Africa |
| Pfizer Investigational Site | Pretoria | Gauteng | 0081 | South Africa |
| Pfizer Investigational Site | Elche | Alicante | 03203 | Spain |
| Pfizer Investigational Site | Palma de Mallorca | Balearic Islands | 07010 | Spain |
| Pfizer Investigational Site | Palma de Mallorca | Balearic Islands | 07014 | Spain |
| Pfizer Investigational Site | Barcelona | Barcelona | 08003 | Spain |
| Pfizer Investigational Site | Barcelona | Barcelona | 08014 | Spain |
| Pfizer Investigational Site | Barcelona | Barcelona | 08034 | Spain |
| Pfizer Investigational Site | Barcelona | Barcelona | 08041 | Spain |
| Pfizer Investigational Site | Terrassa | Barcelona | 08221 | Spain |
| Pfizer Investigational Site | Burgos | Burgos | 09006 | Spain |
| Pfizer Investigational Site | Plasencia | Caceres | 10600 | Spain |
| Pfizer Investigational Site | Madrid | Madrid | 28006 | Spain |
| Pfizer Investigational Site | Madrid | Madrid | 28034 | Spain |
| Pfizer Investigational Site | Madrid | Madrid | 28040 | Spain |
| Pfizer Investigational Site | Madrid | Madrid | 28041 | Spain |
| Pfizer Investigational Site | Madrid | Madrid | 28046 | Spain |
| Pfizer Investigational Site | Madrid | 28006 | Spain |
| Pfizer Investigational Site | Malmö | SE-205 02 | Sweden |
| Pfizer Investigational Site | Basel | Canton of Basel-City | CH-4031 | Switzerland |
| Pfizer Investigational Site | London | London | SE5 9RS | United Kingdom |
| Pfizer Investigational Site | Brighton | BN2 5BE | United Kingdom |
| Pfizer Investigational Site | Glasgow | G20 OXA | United Kingdom |
| Pfizer Investigational Site | London | W6 8RF | United Kingdom |
| Pfizer Investigational Site | Newcastle upon Tyne | NE4 5PL | United Kingdom |
| Pfizer Investigational Site | Penarth | CF64 2XX | United Kingdom |
| Pfizer Investigational Site | Sheffield | S10 2JF | United Kingdom |
| Pfizer Investigational Site | Sheffield | S35 8QS | United Kingdom |
| Pfizer Investigational Site | Swindon | SN3 6BW | United Kingdom |
Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| FG002 | Placebo/Bapineuzumab 1.0 mg/kg | Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| FG003 | Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg | Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| FG004 | Bapineuzumab 2.0 mg/kg/ Bapineuzumab 1.0 mg/kg | Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/Bapineuzumab 0.5 mg/kg | Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| BG001 | Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg | Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| BG002 | Placebo/Bapineuzumab 1.0 mg/kg | Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| BG003 | Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg | Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| BG004 | Bapineuzumab 2.0 mg/kg/Bapineuzumab 1.0 mg/kg | Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Age, Customized | Number | Number of participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Safety Population included all participants who consented to participate in the extension and received at least one dose of the investigational product (in the extension study). | Posted | Number | Number of participants | Up to Week 195 |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study. | Posted | Least Squares Mean | Standard Error | Units on a scale | Weeks 13, 26, 39, 52 and 78 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study. | Posted | Least Squares Mean | Standard Error | Units on a scale | Weeks 13, 26, 39, 52 and 78 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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 participants with Alzheimer's Disease (AD). The DAD is administered to the participants'caregiver in the form of an interview. 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 by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement | The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study. | Posted | Least Squares Mean | Standard Error | Units on a scale | Weeks 13, 26, 39, 52 and 78 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Extension Study Baseline in DAD Score at Weeks 13, 26, 39, 52 and 78 | The DAD measures instrumental and basic activities of daily living in participants with AD. The DAD is administered to the participants'caregiver in the form of an interview. 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 by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement | The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study. | Posted | Least Squares Mean | Standard Error | Units on a scale | Weeks 13, 26, 39, 52 and 78 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement. | The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study. | Posted | Least Squares Mean | Standard Error | Units on a scale | Weeks 26, 52 and 78 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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, night-time 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). Total score=sum of each domain score(range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement. | The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study. | Posted | Least Squares Mean | Standard Error | Units on a scale | Weeks 26, 52 and 78 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state. | The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study. | Posted | Least Squares Mean | Standard Error | Units on a scale | Weeks 6, 19, 32, 45 and 78 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state | Posted | Least Squares Mean | Standard Error | Units on a scale | Weeks 6, 19, 32, 45 and 78 |
|
2.6 years
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo/Bapineuzumab 0.5 mg/kg | Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. | 6 | 39 | 18 | 39 | ||
| EG001 | Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg | Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. | 10 | 66 | 21 | 66 | ||
| EG002 | Placebo/Bapineuzumab 1.0 mg/kg | Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. | 1 | 37 | 15 | 37 | ||
| EG003 | Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg | Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. | 11 | 56 | 15 | 56 | ||
| EG004 | Bapineuzumab 2.0 mg/kg/Bapineuzumab 1.0 mg/kg | Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. | 0 | 4 | 3 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Partial seizures with secondary generalisation | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vasogenic cerebral oedema | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Arteriosclerotic retinopathy | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Folate deficiency | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cerebral microhaemorrhage | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vasogenic cerebral oedema | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
Bapineuzumab program was discontinued prematurely. Efficacy results obtained after Week 78 are not presented due to the very small number of participants after this time point.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C545458 | bapineuzumab |
Not provided
Not provided
Not provided
| >= 65 |
|
| Male |
|
| OG001 | Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg | Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| OG002 | Placebo/Bapineuzumab 1.0 mg/kg | Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| OG003 | Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg | Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
|
|
|
| OG001 | Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg | Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| OG002 | Placebo/Bapineuzumab 1.0 mg/kg | Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| OG003 | Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg | Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
|
|
|
| OG001 | Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg | Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| OG002 | Placebo/Bapineuzumab 1.0 mg/kg | Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| OG003 | Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg | Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
|
|
|
| OG001 | Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg | Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| OG002 | Placebo/Bapineuzumab 1.0 mg/kg | Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| OG003 | Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg | Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
|
|
|
| OG002 | Placebo/Bapineuzumab 1.0 mg/kg | Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| OG003 | Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg | Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
|
|
|
| OG002 | Placebo/Bapineuzumab 1.0 mg/kg | Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| OG003 | Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg | Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
|
|
|
| OG002 |
| Placebo/Bapineuzumab 1.0 mg/kg |
Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
| OG003 | Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg | Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
|
|
|
| OG003 | Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg | Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195. |
|
|
|