Alzheimer Disease Clinical Trial
Official title:
Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation (ALADDIN) VP 104 Study
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 men 65 years and older with mild to moderate Alzheimer's disease who reside in the community.
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 Alzheimer's
disease (AD). The study will include treatment of men 65 years and older with mild to
moderate Alzheimer's 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 2:1 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.
Participant's memory, behavior, and global functioning are assessed during the participant
and caregiver interviews. Each visit takes approximately 2 hours.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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