Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231946
Status:
COMPLETED
Last Update Posted:
2007-09-20
First Post:
2005-09-30
Brief Title:
ALADDIN Study - Phase III Antigonadotropin-Leuprolide in Alzheimers Disease Drug INvestigation VP-AD-301
Sponsor:
Voyager Pharmaceutical Corporation
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Study of VP4896 For the Treatment of Mild-to-Moderate Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2007-09
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 study is designed to investigate the activity of the hormone drug leuprolide acetate in stabilizing cognitive function in mild-to-moderate AD patients
Detailed Description:
VP4896 is a gonadotropin releasing hormone GnRH agonist that binds to and inactivates GnRH receptors on the pituitary gland This decreases the amount of luteinizing hormone released by the pituitary The hypothesis upon which this trial is designed is that luteinizing hormone is the cause of Alzheimers disease VP4896 decreases the amount of luteinizing hormone in the body and therefore may decrease or halt the progression of Alzheimers disease
This is a double-blind placebo-controlled study designed to assess the safety and efficacy of VP4896 a novel formulation of leuprolide acetate in the treatment of subjects with mild-to-moderate AD The study duration is 56 weeks Approximately 555 participants will be recruited from approximately 80 sites in the United States Canada and South America
The study drug will be administered every eight weeks over a 48 week period Male subjects randomized to active treatment will also receive testosterone replacement gel
The change from baseline in ADAS-Cog cognitive test score at Week 50 and ADCS-CGIC global cognitive and behavioral measure at Week 50 will be the primary efficacy endpoints Safety will be assessed at all visits and by phone at Week 1
This is a double-blind placebo-controlled study designed to assess the safety and efficacy of VP4896 a novel formulation of leuprolide acetate in the treatment of subjects with mild-to-moderate AD The study duration is 56 weeks Approximately 555 participants will be recruited from approximately 80 sites in the United States Canada and South America
The study drug will be administered every eight weeks over a 48 week period Male subjects randomized to active treatment will also receive testosterone replacement gel
The change from baseline in ADAS-Cog cognitive test score at Week 50 and ADCS-CGIC global cognitive and behavioral measure at Week 50 will be the primary efficacy endpoints Safety will be assessed at all visits and by phone at Week 1
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