ALADDIN Study - Phase III: Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation (VP-AD-301)
- Conditions
- Alzheimer's Disease
- Registration Number
- NCT00231946
- Lead Sponsor
- Voyager Pharmaceutical Corporation
- 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 pituitary. The hypothesis upon which this trial is designed is that luteinizing hormone is the cause of Alzheimer's disease. VP4896 decreases the amount of luteinizing hormone in the body and, therefore, may decrease or halt the progression of Alzheimer's disease.
This is a double-blind, placebo-controlled, study designed to assess the safety and efficacy of VP4896 (a novel formulation of leuprolide acetate) in the treatment of subjects with mild-to-moderate AD. The study duration is 56 weeks. Approximately 555 participants will be recruited from approximately 80 sites in the United States, Canada, and South America.
The study drug will be administered every eight weeks over a 48 week period. Male subjects randomized to active treatment will also receive testosterone replacement gel.
The change from baseline in ADAS-Cog (cognitive test) score at Week 50 and ADCS-CGIC (global cognitive and behavioral measure) at Week 50 will be the primary efficacy endpoints. Safety will be assessed at all visits and by phone at Week 1.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 555
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Cognitive assessment and Caregiver's impression of change at baseline and at weeks 8, 24, 34, and 50.
- Secondary Outcome Measures
Name Time Method Ability to perform Activities of Daily Living (ADL) at baseline and weeks 8, 24, 34, and 50. Impression of disease severity assessment at week 50.
Trial Locations
- Locations (53)
Pivotal Research Centers
🇺🇸Royal Oak, Michigan, United States
Palm Beach Neurological Group
🇺🇸West Palm Beach, Florida, United States
Quantum Laboratories
🇺🇸West Palm Beach, Florida, United States
Booker, J. Gary, MD, APMC
🇺🇸Shreveport, Louisiana, United States
The Medical Arts Health Research Group
🇨🇦Penticton, British Columbia, Canada
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
ICPS Group
🇺🇸Boston, Massachusetts, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Bexar Diagnostic Medicine Associates
🇺🇸San Antonio, Texas, United States
San Francisco Clinical Research Center
🇺🇸San Francisco, California, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Radiant Research
🇺🇸Denver, Colorado, United States
Colorado Neurology & Headache Center
🇺🇸Denver, Colorado, United States
Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
Butler Hospital
🇺🇸Providence, Rhode Island, United States
Norman Gordon, MD
🇺🇸Providence, Rhode Island, United States
North County Neurology Assoc.
🇺🇸Oceanside, California, United States
Anderson Clinical Research
🇺🇸Loma Linda, California, United States
Pacific Research Network
🇺🇸San Diego, California, United States
Geriatric and Adult Psychiatry
🇺🇸Hamden, Connecticut, United States
Bay Area Research Institute
🇺🇸Lafayette, California, United States
David Trader
🇺🇸Los Angeles, California, United States
Synergy Clinical Research
🇺🇸National City, California, United States
Torrance Clinical Research
🇺🇸Torrance, California, United States
Neurological Research Institute
🇺🇸Santa Monica, California, United States
Brain Matters Research
🇺🇸Delray Beach, Florida, United States
Berma Research Group
🇺🇸Hialeah, Florida, United States
Hunterdon Medical Center
🇺🇸Flemington, New Jersey, United States
Neurology Clinical Research, LLC
🇺🇸Plantation, Florida, United States
Roskamp Institute
🇺🇸Sarasota, Florida, United States
Neurology Center of Ohio
🇺🇸Toledo, Ohio, United States
Medark Clinical Trials
🇺🇸Morgantown, North Carolina, United States
Innovative Clinical Research Center
🇺🇸Alexandria, Virginia, United States
Upstate Clinical Research, LLC
🇺🇸Albany, New York, United States
Toronto Memory Program (Neurology Research Inc.)
🇨🇦Toronto, Ontario, Canada
Pearl Clinical Research, Inc.
🇺🇸Norristown, Pennsylvania, United States
Southwestern Vermont Medical Center
🇺🇸Bennington, Vermont, United States
Grayline Clinical Drug Trials
🇺🇸Wichita Falls, Texas, United States
Pharmacology Research Institute
🇺🇸Riverside, California, United States
Margolin Brain Institute
🇺🇸Fresno, California, United States
NeuroSpecialists, PLLC
🇺🇸Tucson, Arizona, United States
Pharmaceutical Research-Oregon, Inc.
🇺🇸Eugene, Oregon, United States
Comprehensive Neuroscience, Inc.
🇺🇸Darien, Connecticut, United States
Clinical Trial Center, LLC.
🇺🇸Jenkintown, Pennsylvania, United States
Radiant Research - Greer
🇺🇸Greer, South Carolina, United States
Novabyss Inc.
🇨🇦Sherbrooke, Quebec, Canada
Raleigh Neurology Associates, P.A.
🇺🇸Raleigh, North Carolina, United States
Kuakani Medical Center
🇺🇸Honolulu, Hawaii, United States
Meridien Research
🇺🇸Tampa, Florida, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Albuquerque Neuroscience Inc.
🇺🇸Albuquerque, New Mexico, United States
Piedmont Medical Research Associates
🇺🇸Winston-Salem, North Carolina, United States
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada