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| Sponsor: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00416169 |
Purpose
The purpose of this study is to explore the safety and tolerability and the efficacy of galantamine treatment in subjects with Pick Complex/ Frontotemporal Dementia (PC/FTD). The safety and tolerability of galantamine therapy will be assessed over the entire treatment period (26 weeks). The 8 week withdrawal period will be used to confirm the safety of galantamine withdrawal in this subject group and it impact on any symptom improvement achieved during the first 18 weeks of galantamine treatment ( symptom improvement would be expected to stabilize or decline on withdrawal of an effective therapy). The primary efficacy objective is to explore the effect of galantamine on behavior as measured by the Frontal Behavioral Inventory during the randomized withdrawal period. In addition, for subjects with primary progressive aphasia (limited ability for languages), the effects of galantamine on language will be explored using the Aphasia Quotient of the Western Aphasia Battery, and for all subjects the Clinical Global Impressions will be used to explore global change.
| Condition | Intervention | Phase |
|---|---|---|
|
Pick Complex Frontotemporal Dementia |
Drug: galantamine hydrobromide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | An Open Pilot Study to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Pick's Disease/Frontotemporal Dementia /Pick Complex |
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | July 2004 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| Study ID Numbers: | CR003106 |
| Study First Received: | December 22, 2006 |
| Last Updated: | October 19, 2007 |
| ClinicalTrials.gov Identifier: | NCT00416169 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
galantamine hydrobromide Pick Complex Frontotemporal Dementia |
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Parasympathomimetics Pick Disease of the Brain Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Brain Diseases Cholinergic Agents Aphasia, Primary Progressive Signs and Symptoms Mental Disorders Therapeutic Uses Dementia Neurobehavioral Manifestations Nootropic Agents Speech Disorders |
Galantamine Aphasia Nervous System Diseases Language Disorders Central Nervous System Diseases Enzyme Inhibitors Pharmacologic Actions Cholinesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders Autonomic Agents Neurologic Manifestations Peripheral Nervous System Agents Central Nervous System Agents Communication Disorders |