Safety and Efficacy of Galantamine in Patients With Dementia With Lewy Bodies
Status:
Completed
Trial end date:
2004-08-01
Target enrollment:
Participant gender:
Summary
TRIAL SUMMARY:
This is an open-label, 24-week, investigator initiated study to evaluate the safety and
efficacy of galantamine (16 8 to 24 mg/day; flexible dosing) in the treatment of Dementia
with Lewy bodies. The primary efficacy variables will be the NPI -12, the COGDRAS tests of
attention and visuospatial orientation, and the ADCS-CGIC. The secondary efficacy variables
will be the MMSE, ADCS-ADL-Inventory, ADAS-Cog, PSQI, and the use of concomitant rescue
antipsychotic medication. PET scanning will be obtained on 10 patients at one site. An
interim analysis will also be performed. Safety outcome measures will be adverse event
reports, vital signs, physical examinations, ECG, laboratory parameters and the UPDRS (motor
subscale).