A Pilot Study to Explore the Safety and Tolerability of Galantamine HBr in the Treatment of Pick Complex/Frontotemporal Dementia
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.
Drug: galantamine hydrobromide
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
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|
- The safety is incidence of gastrointestinal events; efficacy are FBI, AQ and CGI. Changes will be calculated from baseline to Week 18 and Week 26. Comparisons between the placebo and galantamine groups will use the changes from Weeks 18 to 26.
- Secondary efficacy parameters are: MMSE, MDRS, FAB, NPI, ADCS-ADL Scale, subscales of the WAB and FBI and neurologic exams; safety are AE, ECGs, physical exam, vital signs, and lab tests.
|Study Start Date:||May 2003|
|Study Completion Date:||July 2004|
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|