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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 |
|---|---|---|
|
Frontotemporal Dementia Pick Complex |
Drug: galantamine hydrobromide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
| Enrollment: | 41 |
| Study Start Date: | May 2003 |
| 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 & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| ClinicalTrials.gov Identifier: | NCT00416169 History of Changes |
| Other Study ID Numbers: | CR003106 |
| Study First Received: | December 22, 2006 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
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Frontotemporal Dementia Pick Complex galantamine hydrobromide |
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Dementia Frontotemporal Dementia Aphasia, Primary Progressive Pick Disease of the Brain Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Frontotemporal Lobar Degeneration TDP-43 Proteinopathies Neurodegenerative Diseases Proteostasis Deficiencies Metabolic Diseases Aphasia |
Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Galantamine Parasympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nootropic Agents Central Nervous System Agents Therapeutic Uses |