Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
NCT ID: NCT00479557
Last Updated: 2016-01-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
86 participants
INTERVENTIONAL
2007-05-31
2013-01-31
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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1
arm 1: ACC-001 (Vanutide Cridificar)+ QS-21
ACC-001 + QS-21
Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
2
arm 2: ACC-001
ACC-001
Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12
3
arm 3: QS-21
QS-21
QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
4
Drug: Phosphate Buffered Saline (PBS)
Placebo: Phosphate buffered saline
Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12
Interventions
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ACC-001 + QS-21
Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
ACC-001
Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12
QS-21
QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
Placebo: Phosphate buffered saline
Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12
Eligibility Criteria
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Inclusion Criteria
* Brain MRI consistent with Alzheimer Disease
* Concurent use of Chloniesterase inhibitor or memantine allowed if stable
Exclusion Criteria
* Major psychiatric disorder
* Contraindication to undergo brain MRI
* Clinically significant systemic illness
50 Years
85 Years
ALL
No
Sponsors
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Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC
UNKNOWN
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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Groupe Hospitalier Pitie-Salpetriere
Paris, Cedex 13 (mri), France
Hôpital Pitié-Salpétrière
Paris, Paris, France
Hopital Pellegrin-Centre Mémoire de Recherche et de Ressources
Bordeaux, , France
CHRU de Lille
Lille, , France
CHRU de Lille
Lille (mri), , France
Hôpital Sainte-Marguerite
Marseille, , France
CHU Hôpital Gui de Chaulliac
Montpellier, , France
Groupe Hospitalier Broca-La Rochefoucauld
Paris, , France
Clinique de L'Union
St.-Jean, , France
Hôpital LA GRAVE
Toulouse, , France
Chru Purpan
Toulouse, , France
Clinique PASTEUR
Toulouse, , France
Unversitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin
Berlin, , Germany
Zentralinstitut fuer Seelische Gesundheit
Frankenthal, , Germany
Klinik fuer Psychiatrie und Psychotherapie
Göttingen, , Germany
Zentralinstitut fuer Seelische Gesundheit
Mannheim, , Germany
Technische Universitaet Muenchen, Klinikum rechts der Isar
München, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Clinico y Provincial
Barcelona, Barcelona, Spain
Hospital Universitario Clinico San Carlos
Madrid, Madrid, Spain
Countries
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References
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Pasquier F, Sadowsky C, Holstein A, Leterme Gle P, Peng Y, Jackson N, Fox NC, Ketter N, Liu E, Ryan JM; ACC-001 (QS-21) Study Team. Two Phase 2 Multiple Ascending-Dose Studies of Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Mild-to-Moderate Alzheimer's Disease. J Alzheimers Dis. 2016;51(4):1131-43. doi: 10.3233/JAD-150376.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B2571004
Identifier Type: OTHER
Identifier Source: secondary_id
2006-002061-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3134K1-200
Identifier Type: -
Identifier Source: org_study_id
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