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

NCT00996918 | Terminated Phase 3 Results DMC

• 2 other identifiers: 3133K1-3002B2521003
• Study Type: interventional
• Target: 198
• Locations: 17 countries
• Sites: 82

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

Conditions

Alzheimer Disease

Keywords

antibody

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78.

  Weeks 13, 26, 39, 52 and 78

• Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.

  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.

  Weeks 13, 26, 39, 52 and 78

• Change From Extension Study Baseline in DAD Score at Weeks 13, 26, 39, 52 and 78

  Weeks 13, 26, 39, 52 and 78

• Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.

  Weeks 26, 52 and 78

Study Arms (2)

Bapineuzumab 0.5 mg/kg

EXPERIMENTAL

bapineuzumab

Drug: Bapineuzumab 0.5 mg/kg

Bapineuzumab 1.0 m/kg

EXPERIMENTAL

bapineuzumab

Drug: Bapineuzumab 1.0 m/kg

Interventions

Bapineuzumab 0.5 mg/kg DRUG

Bapineuzumab I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.

Also known as: AAB-001

Bapineuzumab 0.5 mg/kg

Bapineuzumab 1.0 m/kg DRUG

I.V., 1.0 mg/kg, infusion every 13 weeks for a total of 16 infusions.

Also known as: AAB-001

Bapineuzumab 1.0 m/kg

Eligibility Criteria

• Age: 51 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (82)

Pfizer Investigational Site

Hornsby, New South Wales, 2077, Australia

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Adelaide, South Australia, 5000, Australia

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Woodville South, South Australia, 5011, Australia

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Heidelberg Heights, Victoria, 3081, Australia

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Nedlands, Western Australia, 6009, Australia

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Antwerp, 2020, Belgium

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Brussels, 1200, Belgium

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Edegem, 2650, Belgium

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Santiago, Chile, 7530193, Chile

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Santiago, Chile, 7630000, Chile

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Kuopio, FIN-70210, Finland

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Turku, 20520, Finland

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Dijon, France, 21000, France

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Lille, France, 59037, France

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Marseille, France, 13000, France

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Paris, France, 75013, France

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Caen, 14033, France

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Marseille, 13885, France

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Montpellier, 34295, France

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Nantes - Saint Herblain, 44093, France

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Nice, 06000, France

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Poitiers, 86021, France

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Rennes, 35000, France

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Rouen, 76031, France

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Toulouse, 31059, France

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Milan, 20133, Italy

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Roma, 00179, Italy

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Aichi, Japan

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Chiba, Japan

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Fukuoka, Japan

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Hiroshima, Japan

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Hyōgo, Japan

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Kagawa, Japan

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Kanagawa, Japan

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Kyoto, Japan

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Nagano, Japan

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Okayama, Japan

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Osaka, Japan

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Shizuoka, Japan

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Tokyo, Japan

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's-Hertogenbosch, 5223 GZ, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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North Shore, NZ, 622, New Zealand

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Poznan, Poland, 61-289, Poland

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Bydgoszcz, 85-796, Poland

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Krakow, 31-531, Poland

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Warsaw, 01-211, Poland

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Warsaw, 02-097, Poland

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Amadora, Amadora, 2700-276, Portugal

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Coimbra, Coimbra District, 3000-075, Portugal

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Lisbon, Lisbon District, 1649-028, Portugal

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Bratislava, 825 56, Slovakia

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Rimavská Sobota, 979 12, Slovakia

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Johannesburg, Gauteng, 2196, South Africa

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Pretoria, Gauteng, 0081, South Africa

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Elche, Alicante, 03203, Spain

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Palma de Mallorca, Balearic Islands, 07010, Spain

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Palma de Mallorca, Balearic Islands, 07014, Spain

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Barcelona, Barcelona, 08003, Spain

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Barcelona, Barcelona, 08014, Spain

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Barcelona, Barcelona, 08034, Spain

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Barcelona, Barcelona, 08041, Spain

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Terrassa, Barcelona, 08221, Spain

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Burgos, Burgos, 09006, Spain

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Plasencia, Caceres, 10600, Spain

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Madrid, Madrid, 28006, Spain

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Madrid, Madrid, 28034, Spain

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Madrid, Madrid, 28040, Spain

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Madrid, Madrid, 28041, Spain

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Madrid, Madrid, 28046, Spain

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Madrid, 28006, Spain

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Malmo, SE-205 02, Sweden

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Basel, Canton of Basel-City, CH-4031, Switzerland

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London, London, SE5 9RS, United Kingdom

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Brighton, BN2 5BE, United Kingdom

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Glasgow, G20 OXA, United Kingdom

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London, W6 8RF, United Kingdom

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Newcastle upon Tyne, NE4 5PL, United Kingdom

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Penarth, CF64 2XX, United Kingdom

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Sheffield, S10 2JF, United Kingdom

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Sheffield, S35 8QS, United Kingdom

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Swindon, SN3 6BW, United Kingdom

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Related Publications (1)

• 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.

  PMID: 27334799 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Alzheimer Disease

Interventions

bapineuzumab

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

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.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: October 16, 2009
• Study Start: December 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 1, 2014
• Results First Posted: January 1, 2014

Record last verified: 2013-11

Locations

CL (2); ES (16); ZA (2); JP (13); FR (13); FI (2); PL (5); AU (5); PT (3); NZ (1); BE (3); CH (1); SE (1); SL (2); GB (9); NL (2); IT (2)