Status:
COMPLETED
ALADDIN Study - Phase III: Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation (VP-AD-301)
Lead Sponsor:
Voyager Pharmaceutical Corporation
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
60+ years
Phase:
PHASE3
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 pituitar...
Eligibility Criteria
Inclusion
- 60 years of age or older
- Diagnosis of probable mild-to-moderate Alzheimer's Disease
- On a stable dose of an acetylcholinesterase inhibitor (including, but not limited to: donepezil, galantamine, rivastigmine, and tacrine) for at least 120 days prior to baseline and will likely remain on the drug throughout the trial; all participants must be on acetylcholinesterase inhibitors
- No other significant or interfering medical conditions
Exclusion
- Significant neurological disease affecting the brain or psychiatric disease other than AD, such as current untreated major depression, schizophrenia, epilepsy, Parkinson's disease, Creutzfeldt-Jakob's disease, or clinical episode of stroke
- Laboratory or clinical signs of untreated, clinically significant abnormal thyroid function, in the Investigator's opinion
- Received other investigational drugs within 30 days or 5 half-lives prior to baseline, whichever is longer
- Taking other medications, with the exception of estrogen, known to affect serum gonadotropin (Gn) concentrations, including but not limited to goserelin, danazol, or leuprolide
- Other exclusion criteria exist--eligibility can be assessed by the trial site
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
555 Patients enrolled
Trial Details
Trial ID
NCT00231946
Start Date
September 1 2005
Last Update
September 20 2007
Active Locations (59)
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1
Pivotal Research Centers
Peoria, Arizona, United States, 85381
2
NeuroSpecialists, PLLC
Tucson, Arizona, United States, 85741
3
Margolin Brain Institute
Fresno, California, United States, 93720
4
Bay Area Research Institute
Lafayette, California, United States, 94549