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ALADDIN Study: Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation

2014-07-24 14:33:42 | BioPortfolio

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 Alzheimer's 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 Alzheimer's disease who reside in the community.

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 2:1 randomization of drug to placebo. Sample size will include 90 participants

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Alzheimer Disease

Intervention

Leuprolide acetate

Location

Sun Health Research Institute
Sun City
Arizona
United States
85351

Status

Completed

Source

National Institute on Aging (NIA)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:33:42-0400

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