ALADDIN Study - Phase III: Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation (VP-AD-301)
NCT ID: NCT00231946
Last Updated: 2007-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
555 participants
INTERVENTIONAL
2005-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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VP4896
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
60 Years
ALL
No
Sponsors
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Voyager Pharmaceutical Corporation
INDUSTRY
Principal Investigators
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Connie Powers
Role: PRINCIPAL_INVESTIGATOR
Sr. Clinical Scientist, Voyager Pharmaceutical
Locations
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Pivotal Research Centers
Peoria, Arizona, United States
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
Meridien Research
St. Petersburg, Florida, United States
Meridien Research
Tampa, Florida, United States
Palm Beach Neurological Group
West Palm Beach, Florida, United States
Quantum Laboratories
West Palm Beach, Florida, United States
Kuakani Medical Center
Honolulu, Hawaii, United States
Booker, J. Gary, MD, APMC
Shreveport, Louisiana, United States
ICPS Group
Boston, Massachusetts, United States
Pivotal Research Centers
Royal Oak, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Hunterdon Medical Center
Flemington, New Jersey, United States
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, United States
Upstate Clinical Research, LLC
Albany, New York, United States
Medark Clinical Trials
Morgantown, North Carolina, United States
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Neurology Center of Ohio
Toledo, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Pharmaceutical Research-Oregon, Inc.
Eugene, Oregon, United States
Clinical Trial Center, LLC.
Jenkintown, Pennsylvania, United States
Pearl Clinical Research, Inc.
Norristown, Pennsylvania, 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
Radiant Research - Greer
Greer, South Carolina, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Bexar Diagnostic Medicine Associates
San Antonio, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
Southwestern Vermont Medical Center
Bennington, Vermont, United States
Innovative Clinical Research Center
Alexandria, Virginia, United States
The Medical Arts Health Research Group
Penticton, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Toronto Memory Program (Neurology Research Inc.)
Toronto, Ontario, Canada
Novabyss Inc.
Sherbrooke, Quebec, Canada
Countries
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References
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Gregory CW, Bowen RL. Novel therapeutic strategies for Alzheimer's disease based on the forgotten reproductive hormones. Cell Mol Life Sci. 2005 Feb;62(3):313-9. doi: 10.1007/s00018-004-4386-y.
Bowen RL, Atwood CS. Living and dying for sex. A theory of aging based on the modulation of cell cycle signaling by reproductive hormones. Gerontology. 2004 Sep-Oct;50(5):265-90. doi: 10.1159/000079125.
Bowen RL, Verdile G, Liu T, Parlow AF, Perry G, Smith MA, Martins RN, Atwood CS. Luteinizing hormone, a reproductive regulator that modulates the processing of amyloid-beta precursor protein and amyloid-beta deposition. J Biol Chem. 2004 May 7;279(19):20539-45. doi: 10.1074/jbc.M311993200. Epub 2004 Feb 9.
Webber KM, Bowen R, Casadesus G, Perry G, Atwood CS, Smith MA. Gonadotropins and Alzheimer's disease: the link between estrogen replacement therapy and neuroprotection. Acta Neurobiol Exp (Wars). 2004;64(1):113-8. doi: 10.55782/ane-2004-1497.
Zhu X, McShea A, Harris PL, Raina AK, Castellani RJ, Funk JO, Shah S, Atwood C, Bowen R, Bowser R, Morelli L, Perry G, Smith MA. Elevated expression of a regulator of the G2/M phase of the cell cycle, neuronal CIP-1-associated regulator of cyclin B, in Alzheimer's disease. J Neurosci Res. 2004 Mar 1;75(5):698-703. doi: 10.1002/jnr.20028.
Related Links
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Alzheimer's Disease Education and Referral Center
Alzheimer's Association
Other Identifiers
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IA0084
Identifier Type: -
Identifier Source: org_study_id