ALADDIN Study - Phase III: Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation (VP-AD-301)

Completed · Phase 3

Conditions studied: Alzheimer's Disease

In brief

The study is designed to investigate the activity of the hormone drug leuprolide acetate in stabilizing cognitive function in mild-to-moderate AD patients.

Key facts

Study ID

NCT00231946

Run by

Voyager Pharmaceutical Corporation

People needed

555

Starts

2005-09-01

Last updated by the study team

2007-09-20

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NeuroSpecialists, PLLC — Tucson, Arizona, United States
• Margolin Brain Institute — Fresno, California, United States
• Bay Area Research Institute — Lafayette, California, United States
• Anderson Clinical Research — Loma Linda, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• David Trader — Los Angeles, California, United States
• Synergy Clinical Research — National City, California, United States
• Pharmacology Research Institute — Newport Beach, California, United States
• Pharmacology Research Institute — Northridge, California, United States
• North County Neurology Assoc. — Oceanside, California, United States
• Pharmacology Research Institute — Riverside, California, United States
• Pacific Research Network — San Diego, California, United States
• San Francisco Clinical Research Center — San Francisco, California, United States
• Neurological Research Institute — Santa Monica, California, United States
• Torrance Clinical Research — Torrance, California, United States
• Radiant Research — Denver, Colorado, United States
• Colorado Neurology & Headache Center — Denver, Colorado, United States
• Comprehensive Neuroscience, Inc. — Darien, Connecticut, United States
• Geriatric and Adult Psychiatry — Hamden, Connecticut, United States
• Meridien Research — Brookville, Florida, United States
• Brain Matters Research — Delray Beach, Florida, United States
• Berma Research Group — Hialeah, Florida, United States
• Neurology Clinical Research, LLC — Plantation, Florida, United States
• Roskamp Institute — Sarasota, Florida, United States
• Pivotal Research Centers — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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