Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338117
Status:
COMPLETED
Last Update Posted:
2010-04-28
First Post:
2006-06-16
Brief Title:
Safety and Efficacy of High Dose Rapid Titration Galantamine in Patients With Alzheimers Disease
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A European Multi-Center Study to Determine the Safety and Efficacy of Galanthamine Hydrobromide 40mgDay 32 mg Day GAL Base Tid Dose Regimen in Patients Diagnosed With Alzheimer-Type Dementia
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to determine the safety and effectiveness of a relatively high dose of galantamine 32 mg day in a three-times daily dosage compared with placebo in treating patients with Alzheimers disease
Detailed Description:
Alzheimers disease is a progressive degenerative brain disorder that affects memory as well as the ability to concentrate reason and think in abstract form This study was designed to examine the effectiveness and safety of galantamine galant hydrobromide at a relatively high dose compared with treatment with placebo in men and women with Alzheimers disease Approximately 600 patients were screened This was a double-blind study ie neither patients nor investigators knew what treatment was given Before the start of the double-blind phase each patient was randomly assigned to receive either galantamine hydrobromide or placebo ie no active drug The dose was increased weekly at a higher rate than currently recommended in the label until the stable daily dose of 32 mg galantamine was reached All patients took their treatment galantamine or placebo 3 times a day All patients who completed the blinded phase of the study were permitted to enter an open-label phase in which the treatment was made known to both investigators and patients During this additional 24-week phase all patients received treatment with galantamine hydrobromide The effectiveness of study treatment galantamine hydrobromide or placebo was assessed using several measures and included the Mini Mental State Examination MMSE score The MMSE consists of 12 questions and tasks designed to assess severity of Alzheimers disease Additional measures included the European Alzheimer Disease Assessment Scale cognitive score EURO-ADAS-cog a Clinicians Interview Based Impression of Change CIBIC plus and the Nurses Observation Scale for Geriatric Patients NOSGER Safety and tolerability were assessed using physical full and brief examination adverse events reports clinical and laboratory measures and 12-lead ECG results Galant was taken orally as a tablet 3 times a day with meals Patients started their treatment with a total 8 mg of galantamine The dose was increased weekly to a daily cumulative dose of 32 mg the same as 40 mg Gal HBrThis dose was higher and the titration schedule was 4 times more rapid that the 16 mg and 24 mg maintenance doses and 4-weekly titration steps specified in the US label Each phase had a 5-week titration period After 5 weeks patients continued to receive 40 mg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None