Clinical Trial: A Pilot Study to Explore the Safety and Tolerability of Galantamine HBr in the Treatment of Pick Complex/Frontotemporal Dementia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open Pilot Study to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Pick's Disease/Frontotemporal Dementia /Pick Comple
Brief Summary:
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.
Detailed Summary:
Pick Complex (PC) and Frontotemporal Dementia (FTD) are a group of neurodegenerative dementias, initially characterized by frontotemporal lobar atrophy, that have overlapping clinical presentations and pathologic findings. Although the pathogenesis of Pick Complex/Frontotemporal Dementia remains unknown, and the neurotransmitter changes in Pick Complex/Frontotemporal Dementia are not well characterized, there is evidence for decreased cholinergic receptor binding in several cortical regions and decreased serotonin binding in the hypothalamus, frontal cortex, and temporal cortex. Galantamine is a reversible cholinesterase inhibitor. Recent studies indicate that galantamine is also an allosteric modulator at nicotinic cholinergic receptor sites. This nicotinic modulation appears to not only potentiate the response to acetylcholine binding, but also to modulate release of several other neurotransmitters, including serotonin. This pilot study will explore the safety and tolerability and efficacy of galantamine 8 mg and 12 mg twice a day treatment in subjects with Pick Complex/Frontotemporal Dementia. The study comprises an 18 week, open label, galantamine treatment phase followed by an 8 week, randomized, double blind, placebo controlled withdrawal phase. The safety and tolerability of galantamine therapy will be explored during both the open label and randomized withdrawal periods. The 8 week randomized withdrawal period will be used to confirm the safety of galantamine withdrawal in this subject group and its impact on possible symptom improvement achieved during the open label period as a marker for efficacy.
The expectation is that subjects who remain on galantamine for the additional 8 weeks will continue to improve or will remain stable with regard to their behavior, language, cognition, and global function, whereas subjects who are assigned to placebo will show a decli
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Current Primary Outcome: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome: 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.
Original Secondary Outcome: Same as current
Information By: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Dates:
Date Received: December 22, 2006
Date Started: May 2003
Date Completion:
Last Updated: June 6, 2011
Last Verified: January 2011
