A Long-Term Safety And Tolerability Study Of Bapineuzumab In Alzheimer Disease Patients

Alzheimer Disease Clinical Trial

Official title:

A Phase 3 Extension, Multicenter, Double-Blind, Long-Term Safety And Tolerability Trial Of Bapineuzumab (AAB-001, ELN115727) In Subjects With Alzheimer Disease Who Are Apolipoprotein E e4 Noncarriers And Participated In Study 3133K1-3000

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00996918
• Other study ID #: 3133K1-3002
• Secondary ID: B2521003
• Status: Terminated
• Phase: Phase 3
• First received: October 14, 2009
• Last updated: November 12, 2013
• Start date: December 2009
• Est. completion date: November 2012

Study information

• Verified date: November 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 3133K1-3000 (NCT00667810). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 198
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 51 Years and older

Eligibility

Inclusion Criteria:

• Subject has completed study 3133K1-3000 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

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Bapineuzumab 0.5 mg/kg
Bapineuzumab I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.
• Bapineuzumab 1.0 m/kg
I.V., 1.0 mg/kg, infusion every 13 weeks for a total of 16 infusions.

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Adelaide	South Australia
Australia	Pfizer Investigational Site	Heidelberg Heights	Victoria
Australia	Pfizer Investigational Site	Hornsby	New South Wales
Australia	Pfizer Investigational Site	Nedlands	Western Australia
Australia	Pfizer Investigational Site	Woodville South	South Australia
Belgium	Pfizer Investigational Site	Antwerpen
Belgium	Pfizer Investigational Site	Brussels
Belgium	Pfizer Investigational Site	Edegem
Chile	Pfizer Investigational Site	Santiago
Chile	Pfizer Investigational Site	Santiago
Finland	Pfizer Investigational Site	Kuopio
Finland	Pfizer Investigational Site	Turku
France	Pfizer Investigational Site	Caen
France	Pfizer Investigational Site	Dijon
France	Pfizer Investigational Site	Lille
France	Pfizer Investigational Site	Marseille
France	Pfizer Investigational Site	Marseille
France	Pfizer Investigational Site	Montpellier
France	Pfizer Investigational Site	Nantes - Saint Herblain
France	Pfizer Investigational Site	Nice
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Poitiers
France	Pfizer Investigational Site	Rennes
France	Pfizer Investigational Site	Rouen
France	Pfizer Investigational Site	Toulouse
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Roma
Japan	Pfizer Investigational Site	Aichi
Japan	Pfizer Investigational Site	Chiba
Japan	Pfizer Investigational Site	Fukuoka
Japan	Pfizer Investigational Site	Hiroshima
Japan	Pfizer Investigational Site	Hyogo
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
Netherlands	Pfizer Investigational Site	's-Hertogenbosch
Netherlands	Pfizer Investigational Site	Leeuwarden
New Zealand	Pfizer Investigational Site	North Shore	NZ
Poland	Pfizer Investigational Site	Bydgoszcz
Poland	Pfizer Investigational Site	Krakow
Poland	Pfizer Investigational Site	Poznan
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Portugal	Pfizer Investigational Site	Amadora
Portugal	Pfizer Investigational Site	Coimbra
Portugal	Pfizer Investigational Site	Lisboa
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Rimavska Sobota
South Africa	Pfizer Investigational Site	Johannesburg	Gauteng
South Africa	Pfizer Investigational Site	Pretoria	Gauteng
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Burgos
Spain	Pfizer Investigational Site	Elche	Alicante
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Palma de Mallorca	Islas Baleares
Spain	Pfizer Investigational Site	Palma de Mallorca	Islas Baleares
Spain	Pfizer Investigational Site	Plasencia	Caceres
Spain	Pfizer Investigational Site	Terrasa	Barcelona
Sweden	Pfizer Investigational Site	Malmo
Switzerland	Pfizer Investigational Site	Basel	BS
United Kingdom	Pfizer Investigational Site	Brighton
United Kingdom	Pfizer Investigational Site	Glasgow
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Newcastle upon Tyne
United Kingdom	Pfizer Investigational Site	Penarth
United Kingdom	Pfizer Investigational Site	Sheffield
United Kingdom	Pfizer Investigational Site	Sheffield
United Kingdom	Pfizer Investigational Site	Swindon

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Australia,  Belgium,  Chile,  Finland,  France,  Italy,  Japan,  Netherlands,  New Zealand,  Poland,  Portugal,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to Week 195	Yes
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.	Weeks 13, 26, 39, 52 and 78	No
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.	Weeks 13, 26, 39, 52 and 78	No
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	Weeks 13, 26, 39, 52 and 78	No
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	Weeks 13, 26, 39, 52 and 78	No
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.	Weeks 26, 52 and 78	No
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.	Weeks 26, 52 and 78	No
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.	Weeks 6, 19, 32, 45 and 78	No
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	Weeks 6, 19, 32, 45 and 78	No

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