Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035191
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2002-05-02
Brief Title:
A Placebo-controlled Trial to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Vascular Dementia
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized 26-Week Double-Blind Placebo Controlled Trial to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Vascular Dementia
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:
This is a trial to evaluate the safety and effectiveness of galantamine in patients with dementia secondary to blood vessel disease in the brain
Detailed Description:
In a previous 6-month study in patients with both vascular dementia and Alzheimers dementia galantamine demonstrated positive results on thinking functioning behavior speech and overall well being of patients and prevented the behavior symptoms of dementia from appearing This combined study consists of two almost identical 26-week studies that examine the same criteria as the previous study but in a larger patient population dementia has been identified as having been caused by blood vessel disease without Alzheimers disease The study starts with a 4-week period in which current medications for dementia are withdrawn followed by a 26-week double-blind treatment period when patients will receive either placebo or galantamine 8 milligrams or 12 milligrams twice a day Effectiveness will be measured by changes in scores on the Alzheimers Disease Assessment Scale cognitive subscale Alzheimers Disease Cooperative Study Scale the Clinicians Interview-Based Impression of Change Plus and the neuropsychiatric inventory as well as in English-speaking countries only a 10-minute interview of the patient EXIT-25 scale Safety will be evaluated throughout the study based on the incidence and severity of unexpected events laboratory and physical tests and vital signs The hypothesis of the study is that galantamine will improve thinking function behavior speech and overall well being better than placebo A voluntary pharmacogenomic study will be incorporated into the study plan to evaluate whether specific genes are related to the dementia or drug response 8 milligrams mg 2 times a day for 8 weeks then increasing to12 mg if tolerated After 12 weeks dose can be reduced to 8 mg or matching placebo
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