Abstract
Background: This analysis aimed to identify an operational, clinically relevant definition of response achieved in short-term clinical trials to support the identification of patients with Alzheimers disease (AD) who would benefit most from long-term galantamine therapy. Methods: Data were analyzed from 6 randomized placebo-controlled trials of up to 6 months duration, which included patients with mild to moderate AD receiving maintenance doses of galantamine 16-24 mg/day, and from 12 open-label extensions (galantamine 24 mg/day maintenance therapy). Assessments included changes from baseline in the 11-item AD Assessment Scale-Cognitive subscale (ADAS-Cog 11). Results: Pooled analysis of the 5- 6 month trial data showed that at the trial endpoint (2-5 months after reaching maintenance doses), the proportions of galantamine- (n=1,173) versus placebo-treated patients (n=801) with probable AD categorized according to “improved”, “stable” or “non-rapid decline” criteria, were 45.8% versus 27.2%, 59.5% versus 37.1%, and 87.6% versus 69.7%, respectively (observed cases analysis), whilst changes in ADAS-Cog 11 scores versus baseline were -4.9, -4.7 and -2.9 points, respectively, for “improved”, “stable” and “non-rapid decline” galantamine-treated patients (-1.5 points for galantamine recipients overall). “Improved” or “stable” galantamine-treated patients displayed mean improvement in ADAS-Cog 11 scores over baseline until 18 months after starting treatment, and attenuated deterioration thereafter; for galantaminetreated patients exhibiting “non-rapid decline”, mean ADAS-Cog 11 score returned to baseline after approximately 12 months. Conclusions: Patients who demonstrate improvement, stability, or limited cognitive decline 2-5 months after reaching maintenance doses of galantamine are more likely to experience continued benefit from long-term galantamine therapy.
Keywords: Alzheimer's disease, cognition, dementia, galantamine
Current Alzheimer Research
Title: Long-Term Response to Galantamine in Relation to Short-Term Efficacy Data: Pooled Analysis in Patients with Mild to Moderate Alzheimers Disease
Volume: 8 Issue: 2
Author(s): S. Kavanagh, I. Howe, H. R. Brashear, D. Wang, B. Van Baelen, M. Todd and S. Schwalen
Affiliation:
Keywords: Alzheimer's disease, cognition, dementia, galantamine
Abstract: Background: This analysis aimed to identify an operational, clinically relevant definition of response achieved in short-term clinical trials to support the identification of patients with Alzheimers disease (AD) who would benefit most from long-term galantamine therapy. Methods: Data were analyzed from 6 randomized placebo-controlled trials of up to 6 months duration, which included patients with mild to moderate AD receiving maintenance doses of galantamine 16-24 mg/day, and from 12 open-label extensions (galantamine 24 mg/day maintenance therapy). Assessments included changes from baseline in the 11-item AD Assessment Scale-Cognitive subscale (ADAS-Cog 11). Results: Pooled analysis of the 5- 6 month trial data showed that at the trial endpoint (2-5 months after reaching maintenance doses), the proportions of galantamine- (n=1,173) versus placebo-treated patients (n=801) with probable AD categorized according to “improved”, “stable” or “non-rapid decline” criteria, were 45.8% versus 27.2%, 59.5% versus 37.1%, and 87.6% versus 69.7%, respectively (observed cases analysis), whilst changes in ADAS-Cog 11 scores versus baseline were -4.9, -4.7 and -2.9 points, respectively, for “improved”, “stable” and “non-rapid decline” galantamine-treated patients (-1.5 points for galantamine recipients overall). “Improved” or “stable” galantamine-treated patients displayed mean improvement in ADAS-Cog 11 scores over baseline until 18 months after starting treatment, and attenuated deterioration thereafter; for galantaminetreated patients exhibiting “non-rapid decline”, mean ADAS-Cog 11 score returned to baseline after approximately 12 months. Conclusions: Patients who demonstrate improvement, stability, or limited cognitive decline 2-5 months after reaching maintenance doses of galantamine are more likely to experience continued benefit from long-term galantamine therapy.
Export Options
About this article
Cite this article as:
Kavanagh S., Howe I., R. Brashear H., Wang D., Van Baelen B., Todd M. and Schwalen S., Long-Term Response to Galantamine in Relation to Short-Term Efficacy Data: Pooled Analysis in Patients with Mild to Moderate Alzheimers Disease, Current Alzheimer Research 2011; 8 (2) . https://dx.doi.org/10.2174/156720511795256044
DOI https://dx.doi.org/10.2174/156720511795256044 |
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
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
Diagnostic and therapeutic biomarkers of dementia
Dementia affects 18 million people worldwide. Dementia is a syndrome of symptoms caused by brain disease, usually chronic or progressive, clinically characterized by multiple impairments of higher cortical functions such as memory, thinking, orientation, and learning. In addition, in the course of dementia, cognitive deficits are observed, which often hinder ...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
-
Patient Variables Associated with the Assignment of a Formal Dementia Diagnosis to Positively Screened Primary Care Patients
Current Alzheimer Research Principles and Therapeutic Relevance for Targeting Mitochondria in Aging and Neurodegenerative Diseases
Current Pharmaceutical Design Oxidative Stress Modulation Through Habitual Physical Activity
Current Pharmaceutical Design Modulation of the Immune System for the Treatment of Glaucoma
Current Neuropharmacology Neurobiological Underpinnings of the Estrogen - Mood Relationship
Current Psychiatry Reviews Molecular Docking and Dynamic Simulation Studies of Terpenoids of I. wightii (Bentham) H. Hara against Acetylcholinesterase and Histone Deacetylase3 Receptors
Current Computer-Aided Drug Design Antidepressant Related Movement Disorders in the Elderly
Current Psychiatry Reviews Enhancement of Delayed Audiovisual Response in Parkinson’s Disease: A Comparison with Normal Aged Controls
Neuroscience and Biomedical Engineering (Discontinued) Development, Application, and Results from a Precision-medicine Platform that Personalizes Multi-modal Treatment Plans for Mild Alzheimer’s Disease and At-risk Individuals
Current Aging Science Prayer at Midlife is Associated with Reduced Risk of Cognitive Decline in Arabic Women
Current Alzheimer Research Do Geriatric Outpatients Adhere to Medication Changes Advised After Assessment? An Exploratory Pilot Study
Current Clinical Pharmacology Fibrillar β-Amyloid Impairs the Late Phase of Long Term Potentiation
Current Alzheimer Research Endothelins and the Role of Endothelin Antagonists in the Management of Posttraumatic Vasospasm
Current Pharmaceutical Design Molecular Mechanisms of Ischemic Neuronal Cell Death - With Relevance to Alzheimers Disease
Current Alzheimer Research Link Between Chronic Bacterial Inflammation and Alzheimer Disease
CNS & Neurological Disorders - Drug Targets Roles of Adrenomedullin in Hypertension and Hypertensive Organ Damage
Current Hypertension Reviews Manipulation of Microglial Activation as a Therapeutic Strategy in Alzheimers Disease
Current Medicinal Chemistry Lipid-Lowering Therapies for Atherosclerosis: Statins, Fibrates, Ezetimibe and PCSK9 Monoclonal Antibodies
Current Medicinal Chemistry Towards Practical Cognitive Assessment for Detection of Early Dementia: A 30-Minute Computerized Battery Discriminates as Well as Longer Testing
Current Alzheimer Research Serum Insulin Degrading Enzyme Level and Other Factors in Type 2 Diabetic Patients with Mild Cognitive Impairment
Current Alzheimer Research