Dementia With Lewy Bodies Clinical Trial
Official title:
A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)
This 6-month extension study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) in subjects with Dementia with Lewy bodies (DLB) who have participated in the double-blind, placebo-controlled, lead-in study RVT-101-2001.
This 6-month, double-blind,extension study will provide further information regarding the
long-term safety and tolerability of intepirdine (RVT-101) in subjects with DLB who have
participated in the double-blind, placebo-controlled, lead-in study RVT-101-2001. The study
duration for subjects in study centers in the USA will be 12 months.
Subjects who were randomized to the RVT-101 35-mg and RVT-101 70-mg treatment groups in
lead-in study RVT-101-2001 will remain in the same treatment groups for this study; subjects
who were randomized to the placebo treatment group in the lead-in study will be assigned to
the RVT-101 70-mg treatment group in this study.
Various background therapies, including acetylcholinesterase inhibitors and memantine, will
be allowed.
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