Clinical Trial: Safety and Efficacy of Galantamine in Patients With Dementia With Lewy Bodies
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open Label 24-Week, Flexible Dose Trial to Assess the Safety and Efficacy of Galantamine in Patients With Dementia With Lewy Bodies
Brief 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).
Detailed Summary:
TRIAL DESIGN
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Rationale
In a previously published study of DLB treated with rivastigmine, efficacy was seen to be maximized at 20 weeks in multiple parameters compared to placebo. The efficacy was seen in the NPI - 4 as well as the NPI -10, MMSE and a Computerized Cognitive Assessment Systems Score5. There was no change in UPDRS score. The efficacy of rivastigmine for patients with DLB responding greater than 30 percent in behavioral measures was equal to or better than most studies of antipsychotic medications used for behavioral abnormalities in DLB and AD patients.
Since the titration for galantamine involves less time than the titration for rivastigmine, an interim analysis may show efficacy at 12 weeks. However, for complete efficacy and safety evaluations, a 24-week treatment for galantamine is preferable. Since the cholinergic deficits in DLB patients is more profound than that for AD patients, the dose range of 16 8 to 24 mg/day for DLB patients should be sufficient to show efficacy. Since galantamine has previously been shown to be efficacious in the domains of behavior, cognition, ADL's and global assessment in AD patients, we expect efficacy to be shown similarly and perhaps to a greater extent in DLB patients.
TREATMENT OF SUBJECTS
There will be seven visits in this 24-week treatment trial with galantamine for DLB. For all visits a time window of +/- 3 days relative to baseline visit V2 is applicable.
Screen: Visit 1 (-4 week – 0)
At visit 1 (V1) subjects will be evaluated for their
Sponsor: Neurological Research Center
Current Primary Outcome:
- NPI-12
- ADCS-CGIC
- COGDRAS
Original Primary Outcome: Same as current
Current Secondary Outcome:
- ADCS-ADL
- MMSE
- ADAS-Cog
- PSQI
- Concomitant Antipsychotic Medication use
Original Secondary Outcome: Same as current
Information By: Neurological Research Center
Dates:
Date Received: September 29, 2005
Date Started: December 2002
Date Completion: August 2004
Last Updated: December 15, 2005
Last Verified: September 2005