Abstract
Objectives: Long-term safety and tolerability of ACC-001 (vanutide cridificar), an antiamyloid- beta therapeutic vaccine, was evaluated in subjects with mild to moderate Alzheimer’s disease.
Design: Phase 2a extension studies of randomized parent trials were conducted in the United States, European Union, and Japan. Methods: Four immunizations of ACC-001 were administered at the same 3 dose levels (3, 10, and 30 μg) to subjects randomized in the parent studies; ACC-001 was administered with QS-21 adjuvant. Safety, tolerability, and immunogenicity were assessed during active treatment and 6-month follow-up. Results: ACC-001 + QS-21 was well tolerated in the United States (N=110) and European Union (N=50), and Japan (N=53) extension studies; safety profile was similar to that observed in the parent studies, and no new safety signals were identified. Overall, injection site reactions were the most common adverse event in these studies. Anti-amyloid antibody titers were elicited in all groups, with the highest titers observed in subjects who received ACC-001 + QS-21 in both the parent and extension studies. Conclusions: Long-term exposure to ACC-001 + QS-21 was well tolerated in subjects with Alzheimer’s disease, suggesting that side effects do not pose a principal limitation for anti-amyloid active immunotherapy. The highest anti-amyloid-beta IgG titers are elicited during long-term therapy with ACC-001 + QS-21 compared with other regimens.Keywords: Alzheimer’s disease, amyloid-beta, amyloid plaques, antibody, immunotherapy, vaccine.
Current Alzheimer Research
Title:Long-Term Extensions of Randomized Vaccination Trials of ACC-001 and QS-21 in Mild to Moderate Alzheimer’s Disease
Volume: 14 Issue: 7
Author(s): Michael Hull*, Carl Sadowsky, Heii Arai, Ghislaine Le Prince Leterme, Ann Holstein, Kevin Booth, Yahong Peng, Tamotsu Yoshiyama, Hideo Suzuki, Nzeera Ketter, Enchi Liu and J. Michael Ryan
Affiliation:
- Clinic for Geriatric Psychiatry, Center for Psychiatry Emmendingen, Neubronnstraße 25, D-79312 Emmendingen,Germany
Keywords: Alzheimer’s disease, amyloid-beta, amyloid plaques, antibody, immunotherapy, vaccine.
Abstract: Objectives: Long-term safety and tolerability of ACC-001 (vanutide cridificar), an antiamyloid- beta therapeutic vaccine, was evaluated in subjects with mild to moderate Alzheimer’s disease.
Design: Phase 2a extension studies of randomized parent trials were conducted in the United States, European Union, and Japan. Methods: Four immunizations of ACC-001 were administered at the same 3 dose levels (3, 10, and 30 μg) to subjects randomized in the parent studies; ACC-001 was administered with QS-21 adjuvant. Safety, tolerability, and immunogenicity were assessed during active treatment and 6-month follow-up. Results: ACC-001 + QS-21 was well tolerated in the United States (N=110) and European Union (N=50), and Japan (N=53) extension studies; safety profile was similar to that observed in the parent studies, and no new safety signals were identified. Overall, injection site reactions were the most common adverse event in these studies. Anti-amyloid antibody titers were elicited in all groups, with the highest titers observed in subjects who received ACC-001 + QS-21 in both the parent and extension studies. Conclusions: Long-term exposure to ACC-001 + QS-21 was well tolerated in subjects with Alzheimer’s disease, suggesting that side effects do not pose a principal limitation for anti-amyloid active immunotherapy. The highest anti-amyloid-beta IgG titers are elicited during long-term therapy with ACC-001 + QS-21 compared with other regimens.Export Options
About this article
Cite this article as:
Hull Michael*, Sadowsky Carl, Arai Heii, Leterme Le Prince Ghislaine, Holstein Ann, Booth Kevin, Peng Yahong, Yoshiyama Tamotsu, Suzuki Hideo, Ketter Nzeera, Liu Enchi and Ryan Michael J., Long-Term Extensions of Randomized Vaccination Trials of ACC-001 and QS-21 in Mild to Moderate Alzheimer’s Disease, Current Alzheimer Research 2017; 14 (7) . https://dx.doi.org/10.2174/1567205014666170117101537
DOI https://dx.doi.org/10.2174/1567205014666170117101537 |
Print ISSN 1567-2050 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-5828 |
Call for Papers in Thematic Issues
New Advances in the Prevention, Diagnosis, Treatment, and Rehabilitation of Alzheimer's Disease
Aims and Scope: Introduction: Alzheimer's disease (AD) poses a significant global health challenge, with an increasing prevalence that demands concerted efforts to advance our understanding and strategies for prevention, diagnosis, treatment, and rehabilitation. This thematic issue aims to bring together cutting-edge research and innovative approaches from multidisciplinary perspectives to address ...read more
Alzheimer's Disease Drug Development
Alzheimer's disease is a progressive neurodegenerative disorder that affects millions of people worldwide. Despite decades of research, no cure or disease-modifying treatment is available yet. Therefore, the need for developing effective therapies to treat Alzheimer's disease is an urgent matter. This special issue aims to provide a comprehensive overview of ...read more
Current updates on the Role of Neuroinflammation in Neurodegenerative Disorders
Neuroinflammation is an invariable hallmark of chronic and acute neurodegenerative disorders and has long been considered a potential drug target for Alzheimer?s disease (AD) and dementia. Significant evidence of inflammatory processes as a feature of AD is provided by the presence of inflammatory markers in plasma, CSF and postmortem brain ...read more
Deep Learning for Advancing Alzheimer's Disease Research
Alzheimer's disease (AD) poses a significant global health challenge, with an increasing number of individuals affected yearly. Deep learning, a subfield of artificial intelligence, has shown immense potential in various domains, including healthcare. This thematic issue of Current Alzheimer Research explores the application of deep learning techniques in advancing our ...read more
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
- Announcements
Related Articles
-
Patent Ductus Arteriosus in Extreme Prematurity: Role of Echocar-diography and Other Imaging Techniques
Current Pediatric Reviews Ovarian Tissue Vitrification: Modalities, Challenges and Potentials
Current Women`s Health Reviews Medical Treatment of Uterine Arteriovenous Malformations: A Case Report
Current Women`s Health Reviews New Therapeutic Strategies in Perinatal Stroke
Current Drug Targets - CNS & Neurological Disorders Renal Development: A Complex Process Dependent on Inductive Interaction
Current Pediatric Reviews Regulation of Cell Migration and Invasion by Specific Modules of uPA: Mechanistic Insights and Specific Inhibitors
Current Drug Targets Hereditary Haemorrhagic Telangiectasia (HHT): Genetic and Molecular Aspects
Current Pharmaceutical Design Use and Safety of Calcium Channel Blockers in Obstetrics
Current Medicinal Chemistry Exploring Old Drugs for the Treatment of Hematological Malignancies
Current Medicinal Chemistry Application of Dual-Source CT Coronary Angiography in Type 2 Diabetic Patients with Symptomatic Coronary Heart Disease
Current Vascular Pharmacology Surface Antigens/Receptors for Targeted Cancer Treatment: The GnRH Receptor / Binding Site for Targeted Adenocarcinoma Therapy
Current Cancer Drug Targets Progesterone/Progestagens to Prevent Preterm Birth: When and How
Current Women`s Health Reviews Cutaneomeningospinal Angiomatosis (Cobb Syndrome) in a Young Patient
CNS & Neurological Disorders - Drug Targets Medical Treatment of Aortic Aneurysms in Marfan Syndrome and other Heritable Conditions
Current Cardiology Reviews The Neurovascular Unit: Focus on the Regulation of Arterial Smooth Muscle Cells
Current Neurovascular Research Is the Hepatic Factor a miRNA that Maintains the Integrity of Pulmonary Microvasculature by Inhibiting the Vascular Endothelial Growth Factor?
Current Cardiology Reviews ACE Inhibition of Plant Alkaloids Targeted Approach for Selective Inhibition
Mini-Reviews in Organic Chemistry The Small Bowel: An Imaging Guide
Current Medical Imaging Adipose Derived Stem Cells for Musculoskeletal Regeneration: Recent Patents and Future Perspectives
Recent Patents on Regenerative Medicine Focal Adhesion Kinase: From In Vitro Studies to Functional Analyses In Vivo
Current Protein & Peptide Science