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| Sponsor: | Stavanger University Hospital |
|---|---|
| Collaborators: |
King's College London Lund University |
| Information provided by: | Stavanger University Hospital |
| ClinicalTrials.gov Identifier: | NCT00630500 |
Purpose
A 24-week placebo-controlled parallel group multicentre trial to study the safety and efficacy of memantine in patients with dementia associated with Parkinson's disease and dementia with Lewy bodies. It is hypothesized that memantine will be safe and well tolerated, and more effective than placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Dementia Associated With Parkinson's Disease Dementia With Lewy Bodies |
Drug: Memantine Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Placebo Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Placebo-Controlled Multicentre Trial of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies |
| Estimated Enrollment: | 74 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | March 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| A: Experimental |
Drug: Memantine
Tablets, 5 or 10 mg, twice daily
|
| B: Placebo Comparator |
Drug: Placebo
Tablets, 5 or 10 mg, twice daily, 6 months
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Katja Kosssanowski, Psychol | 44-207-848-8195 | Katja.Kossakowski@kcl.ac.uk |
| Contact: Zuneera Kahn, RN | 55-207-848-8071 | zunera.2.khan@kcl.ac.uk |
| Norway | |
| Stavanger University Hospital, Old Age Psychiatry Clinic | Recruiting |
| Stavanger, Norway, 4005 | |
| Contact: Hilde Maryanayagam, RN 47-5151-5196 hrm@sus.no | |
| Contact: Ingrid Braut, RN 47-5151-5196 bril@sus.no | |
| Principal Investigator: Dag Aarsland, MD, PhD | |
| Sub-Investigator: Guido Alves, MD | |
| Sweden | |
| Clinical Memory Research Unit, Neuropsychiatric Clinic, University Hospital Malmo | Recruiting |
| Malmo, Sweden, 20502 | |
| Contact: Marie Persson, RN 46-4033-5522 Marie.e.persson@skane.se | |
| Contact: Eva Falk-Langebro, RN 46-4033-5529 Eva.Falk-Langebro@skane.se | |
| Principal Investigator: Elisabet Londos, MD, PhD | |
| Sub-Investigator: Fredrik Bostrom, MD | |
| United Kingdom | |
| King's COllege London | Recruiting |
| London, United Kingdom, SE1 1UL | |
| Contact: Katja Kossanowski, RN 44-207-848-8195 Katja.Kossakowski@kcl.ac.uk | |
| Contact: Zuneera Kahn 44-207-848-8071 zunera.2.khan@kcl.ac.uk | |
| Principal Investigator: Clive Ballard, MD | |
| United Kingdom, Essex | |
| Mental Health Unit | Recruiting |
| Epping, Essex, United Kingdom, CM16 6TN | |
| Contact: Lean Lee, RN 44-12-7982-7894 lean.lee@nepft.nhs.uk | |
| Principal Investigator: Zuzana Walker, MD | |
| Principal Investigator: | Dag Aarsland, MD, PhD | Stavanger University Hospital |
More Information
| Responsible Party: | Stavanger University Hospital ( Dag Aarsland ) |
| Study ID Numbers: | MEMPDD-130206 |
| Study First Received: | February 27, 2008 |
| Last Updated: | February 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00630500 History of Changes |
| Health Authority: | Norway: Norwegian Medicines Agency |
|
Dementia associated with Parkinson's disease Dementia with Lewy bodies Memantine Placebo-controlled Parallel group |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Antiparkinson Agents Central Nervous System Diseases Excitatory Amino Acid Agents Lewy Body Disease Brain Diseases Neurodegenerative Diseases |
Pharmacologic Actions Delirium, Dementia, Amnestic, Cognitive Disorders Parkinson Disease Movement Disorders Mental Disorders Therapeutic Uses Memantine Dopamine Agents Parkinsonian Disorders Dementia Central Nervous System Agents Excitatory Amino Acid Antagonists |