Long Term Extension Study Evaluating Safety, Tolerability and Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
NCT ID: NCT00955409
Last Updated: 2021-03-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2009-11-05
2013-12-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ACC-001(3µg) + QS21
ACC-001(3µg) + QS21
ACC-001(3µg) + QS21
Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
ACC-001(10µg) + QS21
ACC-001(10µg) + QS21
ACC-001(10µg) + QS21
Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
ACC-001(30µg) + QS21
ACC-001(30µg) + QS21
ACC-001(30µg) + QS21
Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
Interventions
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ACC-001(3µg) + QS21
Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
ACC-001(10µg) + QS21
Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
ACC-001(30µg) + QS21
Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
Eligibility Criteria
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Exclusion Criteria
* Significant Neurological Disease other than Alzheimer's disease
* Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200 study (NCT00479557)
* Clinically significant systemic illness
50 Years
85 Years
ALL
No
Sponsors
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JANSSEN Alzheimer Immunotherapy Research & Development, LLC
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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CMRR Bordeaux CHU Pellegrin
Bordeaux, , France
Hopital Roger Salengro
Lille, , France
Hôpital Roger Salengro
Lille, , France
CHU La Timone
Marseille, , France
Groupe Hospitalier Broca-La Rochefoucauld
Paris, , France
Groupe Hospitalier Pitie-Salpetriere
Paris, , France
Hôpital Pitié-Salpétrière
Paris, , France
Hôpital La Grave
Toulouse, , France
Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin
Berlin, , Germany
Universitatsklinikum und Poliklinik der Uni Bonn
Bonn, , Germany
Klinikum der Albert-Ludwigs-Universitaet Freiburg
Freiburg im Breisgau, , Germany
Klinik fuer Psychiatrie und Psychotherapie
Göttingen, , Germany
Zentralinstitut fuer Seelische Gesundheit Mannheim
Mannheim, , Germany
Technische Universität München
Munich, , Germany
Hospital del Mar
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Clinico y Provincial
Barcelona, , Spain
Countries
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Related Links
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Other Identifiers
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B2571007
Identifier Type: OTHER
Identifier Source: secondary_id
2009-010922-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3134K1-2203
Identifier Type: -
Identifier Source: org_study_id
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