Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00063310
Status:
COMPLETED
Last Update Posted:
2009-12-11
First Post:
2003-06-25
Brief Title:
ALADDIN Study Antigonadotropin-Leuprolide in Alzheimers Disease Drug INvestigation
Sponsor:
Voyager Pharmaceutical Corporation
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Antigonadotropin-Leuprolide in Alzheimers Disease Drug INvestigation ALADDIN
Status:
COMPLETED
Status Verified Date:
2006-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 women leuprolide is commonly used to treat hormone related conditions such as endometriosis and uterine fibroids The study will include treatment of women 65 years and older with mild to moderate Alzheimers disease who reside in the community
Detailed Description:
The study will include the treatment of participants with mild to moderate AD and 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
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IND 66415 | None | None | None |