Abstract
To evaluate the effects of galantamine withdrawal, and compare this with uninterrupted therapy, two 6-week double-blind withdrawal studies (Studies 1 and 2) were performed. These enrolled individuals who had completed one of two 3- or 5-month randomized clinical trials (parent trials) involving patients with mild to moderate Alzheimers disease (AD). In Study 1 (GAL-USA-11; n723), patients continuously treated with galantamine 16 mg/day exhibited a mean (± standard error [SE]) improvement in 11-item cognitive subscale of the Alzheimers Disease Assessment Scale score of 1.8 (± 0.46) points at Week 6 compared with the parent trial baseline, (p < 0.001 vs placebo; observed cases analysis). Over the same period, patients switched from galantamine to placebo and those who had received continuous placebo, exhibited mean (± SE) deteriorations of 0.7 (± 0.49) and 1.2 (± 0.49) points, respectively. Similar trends were apparent in Study 2 (GAL-USA-5; n=118). In Study 1, subgroup analyses demonstrated cognitive benefits with continuing galantamine treatment and deterioration associated with galantamine withdrawal in patients with advanced moderate AD (baseline Mini- Mental State Examination score ≤14) and in individuals deemed non-responsive in terms of Clinicians Interview-Based Impression of Change-plus Caregiver Input (CIBIC-plus) evaluation at the end of the parent trial (CIBIC-plus score > 4). No safety issues were identified. In patients with mild to moderate AD who have exhibited cognitive benefits from up to 5 months galantamine treatment, continuing therapy reinforces previously achieved benefit, whereas in patients in whom galantamine is discontinued, although no safety concerns arise, the natural progression of AD is apparent.
Keywords: Alzheimer's disease, clinical trial, dementia, galantamine, randomized withdrawal, treatment, galantamine discontinuation, ADAS-cog/11 score, CIBIC-plus evaluation
Current Alzheimer Research
Title: Effects of Galantamine in Alzheimers Disease: Double-blind Withdrawal Studies Evaluating Sustained Versus Interrupted Treatment
Volume: 8 Issue: 7
Author(s): M. Gaudig, U. Richarz, J. Han, B. Van Baelen and B. Schauble
Affiliation:
Keywords: Alzheimer's disease, clinical trial, dementia, galantamine, randomized withdrawal, treatment, galantamine discontinuation, ADAS-cog/11 score, CIBIC-plus evaluation
Abstract: To evaluate the effects of galantamine withdrawal, and compare this with uninterrupted therapy, two 6-week double-blind withdrawal studies (Studies 1 and 2) were performed. These enrolled individuals who had completed one of two 3- or 5-month randomized clinical trials (parent trials) involving patients with mild to moderate Alzheimers disease (AD). In Study 1 (GAL-USA-11; n723), patients continuously treated with galantamine 16 mg/day exhibited a mean (± standard error [SE]) improvement in 11-item cognitive subscale of the Alzheimers Disease Assessment Scale score of 1.8 (± 0.46) points at Week 6 compared with the parent trial baseline, (p < 0.001 vs placebo; observed cases analysis). Over the same period, patients switched from galantamine to placebo and those who had received continuous placebo, exhibited mean (± SE) deteriorations of 0.7 (± 0.49) and 1.2 (± 0.49) points, respectively. Similar trends were apparent in Study 2 (GAL-USA-5; n=118). In Study 1, subgroup analyses demonstrated cognitive benefits with continuing galantamine treatment and deterioration associated with galantamine withdrawal in patients with advanced moderate AD (baseline Mini- Mental State Examination score ≤14) and in individuals deemed non-responsive in terms of Clinicians Interview-Based Impression of Change-plus Caregiver Input (CIBIC-plus) evaluation at the end of the parent trial (CIBIC-plus score > 4). No safety issues were identified. In patients with mild to moderate AD who have exhibited cognitive benefits from up to 5 months galantamine treatment, continuing therapy reinforces previously achieved benefit, whereas in patients in whom galantamine is discontinued, although no safety concerns arise, the natural progression of AD is apparent.
Export Options
About this article
Cite this article as:
Gaudig M., Richarz U., Han J., Van Baelen B. and Schauble B., Effects of Galantamine in Alzheimers Disease: Double-blind Withdrawal Studies Evaluating Sustained Versus Interrupted Treatment, Current Alzheimer Research 2011; 8 (7) . https://dx.doi.org/10.2174/156720511797633205
DOI https://dx.doi.org/10.2174/156720511797633205 |
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
-
Perspectives on Medicinal Properties of Benzoquinone Compounds
Mini-Reviews in Medicinal Chemistry Lipid Based Anti-Retroviral Nanocarriers: A Review of Current Literature and Ongoing Studies
Drug Delivery Letters Phenomenology and Neurobiology of Childhood Onset Schizophrenia
Current Psychiatry Reviews Perioperative Management of Intracranial Aneurysm and Subarachnoid Hemorrhage
Current Pharmaceutical Design Derivatives of Resveratrol: Potential Agents in Prevention and Treatment of Cardiovascular Disease
Current Medicinal Chemistry Antioxidants in Health, Disease and Aging
CNS & Neurological Disorders - Drug Targets Differential Regulation of Neurotoxin in HIV Clades: Role of Cocaine and Methamphetamine
Current HIV Research Coumarins as Promising Scaffold for the Treatment of Age-related Diseases – An Overview of the Last Five Years
Current Topics in Medicinal Chemistry Role of the Transglutaminase Enzymes in the Nervous System and their Possible Involvement in Neurodegenerative Diseases
Current Medicinal Chemistry Dysfunction of Endoplasmic Reticulum (ER) and Mitochondria (MT) in Alzheimer's Disease: The Role of the ER-MT Cross-Talk
Current Alzheimer Research Is the Deficiency of Vitamin B12 Related to Oxidative Stress and Neurotoxicity in Parkinsons Patients?
CNS & Neurological Disorders - Drug Targets QSAR, Docking, and CoMFA Studies of GSK3 Inhibitors
Current Pharmaceutical Design The Impact of AD Drug Treatments on Event-Related Potentials as Markers of Disease Conversion
Current Alzheimer Research Nano Clinoptilolite: Highly Efficient Catalyst for the Synthesis of Chromene Derivatives Under Solvent-Free Conditions
Combinatorial Chemistry & High Throughput Screening Controversies in Pharmacological Treatment of Inflammatory Component of Macular Edema
Current Pharmaceutical Design Stress, Depression, Resilience and Ageing: A Role for the LPA-LPA1 Pathway
Current Neuropharmacology There is no Failure, Only Discovery—the Year Ahead for CARving New Paths
Current Alzheimer Research The Animal Models of Dementia and Alzheimer’s Disease for Pre-Clinical Testing and Clinical Translation
Current Alzheimer Research Recent Studies on Design and Development of Drugs Against Alzheimer’s Disease (AD) Based on Inhibition of BACE-1 and Other AD-causative Agents
Current Topics in Medicinal Chemistry Importance of P-gp PET Imaging in Pharmacology
Current Pharmaceutical Design