Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076440
Status:
COMPLETED
Last Update Posted:
2009-12-11
First Post:
2004-01-22
Brief Title:
Antigonadotropin-Leuprolide in Alzheimers Disease Drug INvestigation ALADDIN VP 104 Study
Sponsor:
Voyager Pharmaceutical Corporation
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Antigonadotropin-Leuprolide in Alzheimers Disease Drug INvestigation ALADDIN VP 104 Study
Status:
COMPLETED
Status Verified Date:
2007-03
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:
ALADDIN is a research study to investigate the safety and effectiveness of leuprolide a hormone drug to improve the cognitive function and slow the progression of Alzheimers disease AD in men 65 years and older with mild to moderate Alzheimers disease who reside in the community
Detailed Description:
ALADDIN is a clinical trial investigating the safety and effectiveness of leuprolide a hormone drug to improve the cognitive function and slow the progression of Alzheimers disease AD The study will include treatment of men 65 years and older with mild to moderate Alzheimers disease who reside in the community The objective is to evaluate the safety and efficacy of two different doses of leuprolide to improve the cognitive function and slow the progression of AD as measured by the ADAS-COG and the Clinical Global Impression CGI Measures of behavioral disturbances and quality of life of the caregiver will be made also The study design is randomized double blind placebo-controlled parallel group design with a 21 randomization of drug to placebo Sample size will include 90 participants from multiple test sites
Following initial screening and baseline visits the participant and caregiver will visit the site 8 times for a total of 10 visits over 48 weeks The drug is administered via injection every 3 months Safety assessments are completed and psychometric testing is done Participants memory behavior and global functioning are assessed during the participant and caregiver interviews Each visit takes approximately 2 hours
Following initial screening and baseline visits the participant and caregiver will visit the site 8 times for a total of 10 visits over 48 weeks The drug is administered via injection every 3 months Safety assessments are completed and psychometric testing is done Participants memory behavior and global functioning are assessed during the participant and caregiver interviews Each visit takes approximately 2 hours
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