Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236431
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-10-07
Brief Title:
A Study to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment MCI Clinically at Risk for Development of Clinically Probable Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2010-11
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 is to evaluate the efficacy and safety of galantamine treatment in patients with mild cognitive impairment
Detailed Description:
This is an international multicenter double-blind randomized placebo-controlled trial Patients with mild cognitive impairment MCI who are clinically at risk for development of Alzheimers disease will be treated for 24 months with either placebo or galantamine hydrobromide Memory and overall clinical improvement will be evaluated using the Alzheimers Disease Assessment Scale with cognitive subscale adapted to MCI ADAS-cogMCI and the Clinical Dementia Rating Sum of the Boxes CDR-SB Overall functional skills and the severity of dementia will be assessed with the Clinical Dementia Rating Sum of the Boxes CDR-SB and the overall Clinical Dementia Rating CDR score Additional assessments include the Digit Symbol Substitution Test DSST to measure attention Safety will be assessed using adverse event reports vital signs laboratory parameters physical examination and electrocardiogram The study hypothesis is that treatment with galantamine will be well tolerated and compared with placebo will significantly improve the signs and symptoms associated with mild cognitive impairment in patients who are considered likely to develop Alzheimers disease Galantamine hydrobromide immediate-release tablets 4 8 or 12 milligrams taken by mouth 2 times daily 8mgday for 4 weeks 16mgday for 4 weeks then increased to 24mgday for the remainder of the 24-month trial Doses may be reduced at investigators discretion after 12 weeks
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