ALADDIN Study - Phase III: Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation (VP-AD-301)
This study has been completed.
Sponsor:
Voyager Pharmaceutical Corporation
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00231946
First received: September 30, 2005
Last updated: September 18, 2007
Last verified: September 2007
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Purpose
The study is designed to investigate the activity of the hormone drug leuprolide acetate in stabilizing cognitive function in mild-to-moderate AD patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: VP4896 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Double-Blind Placebo-Controlled Study of VP4896 For the Treatment of Mild-to-Moderate Alzheimer's Disease |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
Drug Information available for:
Leuprolide acetate
U.S. FDA Resources
Further study details as provided by National Institute on Aging (NIA):
Primary Outcome Measures:
- Cognitive assessment and Caregiver's impression of change at baseline and at weeks 8, 24, 34, and 50.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 555 |
| Study Start Date: | September 2005 |
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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231946
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Hide Study LocationsLocations
| United States, Arizona | |
| Pivotal Research Centers | |
| Peoria, Arizona, United States, 85381 | |
| NeuroSpecialists, PLLC | |
| Tucson, Arizona, United States, 85741 | |
| United States, California | |
| Margolin Brain Institute | |
| Fresno, California, United States, 93720 | |
| Bay Area Research Institute | |
| Lafayette, California, United States, 94549 | |
| Anderson Clinical Research | |
| Loma Linda, California, United States, 92354 | |
| Pharmacology Research Institute | |
| Los Alamitos, California, United States, 90720 | |
| David Trader | |
| Los Angeles, California, United States, 90035 | |
| Synergy Clinical Research | |
| National City, California, United States, 91950 | |
| Pharmacology Research Institute | |
| Newport Beach, California, United States, 92660 | |
| Pharmacology Research Institute | |
| Northridge, California, United States, 91324 | |
| North County Neurology Assoc. | |
| Oceanside, California, United States, 92056 | |
| Pharmacology Research Institute | |
| Riverside, California, United States, 92056 | |
| Pacific Research Network | |
| San Diego, California, United States, 92103 | |
| San Francisco Clinical Research Center | |
| San Francisco, California, United States, 94109 | |
| Neurological Research Institute | |
| Santa Monica, California, United States, 90404 | |
| Torrance Clinical Research | |
| Torrance, California, United States, 90505 | |
| United States, Colorado | |
| Colorado Neurology & Headache Center | |
| Denver, Colorado, United States, 80218 | |
| Radiant Research | |
| Denver, Colorado, United States, 80212 | |
| United States, Connecticut | |
| Comprehensive Neuroscience, Inc. | |
| Darien, Connecticut, United States, 06820 | |
| Geriatric and Adult Psychiatry | |
| Hamden, Connecticut, United States, 06518 | |
| United States, Florida | |
| Meridien Research | |
| Brookville, Florida, United States, 34613 | |
| Brain Matters Research | |
| Delray Beach, Florida, United States, 33445 | |
| Berma Research Group | |
| Hialeah, Florida, United States, 33016 | |
| Neurology Clinical Research, LLC | |
| Plantation, Florida, United States, 33324 | |
| Roskamp Institute | |
| Sarasota, Florida, United States, 34243 | |
| Meridien Research | |
| St. Petersburg, Florida, United States, 33709 | |
| Meridien Research | |
| Tampa, Florida, United States, 33609 | |
| Quantum Laboratories | |
| West Palm Beach, Florida, United States, 33409 | |
| Palm Beach Neurological Group | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Hawaii | |
| Kuakani Medical Center | |
| Honolulu, Hawaii, United States, 96817 | |
| United States, Louisiana | |
| Booker, J. Gary, MD, APMC | |
| Shreveport, Louisiana, United States, 71104 | |
| United States, Massachusetts | |
| ICPS Group | |
| Boston, Massachusetts, United States, 02131 | |
| United States, Michigan | |
| Pivotal Research Centers | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New Jersey | |
| Hunterdon Medical Center | |
| Flemington, New Jersey, United States, 08822 | |
| United States, New Mexico | |
| Albuquerque Neuroscience Inc. | |
| Albuquerque, New Mexico, United States, 87102 | |
| United States, New York | |
| Upstate Clinical Research, LLC | |
| Albany, New York, United States, 12205 | |
| United States, North Carolina | |
| Medark Clinical Trials | |
| Morgantown, North Carolina, United States, 28655 | |
| Raleigh Neurology Associates, P.A. | |
| Raleigh, North Carolina, United States, 27607 | |
| Piedmont Medical Research Associates | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| Neurology Center of Ohio | |
| Toledo, Ohio, United States, 43623 | |
| United States, Oklahoma | |
| IPS Research Company | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| United States, Oregon | |
| Pharmaceutical Research-Oregon, Inc. | |
| Eugene, Oregon, United States, 97401 | |
| United States, Pennsylvania | |
| Clinical Trial Center, LLC. | |
| Jenkintown, Pennsylvania, United States, 19046 | |
| Pearl Clinical Research, Inc. | |
| Norristown, Pennsylvania, United States, 19401 | |
| United States, Rhode Island | |
| Memory Research Institute | |
| East Providence, Rhode Island, United States, 02914 | |
| Butler Hospital | |
| Providence, Rhode Island, United States, 02906 | |
| Norman Gordon, MD | |
| Providence, Rhode Island, United States, 02916 | |
| United States, South Carolina | |
| Radiant Research - Greer | |
| Greer, South Carolina, United States, 29651 | |
| United States, Texas | |
| University of Texas Health Science Center at Houston | |
| Houston, Texas, United States, 77030 | |
| Bexar Diagnostic Medicine Associates | |
| San Antonio, Texas, United States, 78229 | |
| Grayline Clinical Drug Trials | |
| Wichita Falls, Texas, United States, 76309 | |
| United States, Vermont | |
| Southwestern Vermont Medical Center | |
| Bennington, Vermont, United States, 05201 | |
| United States, Virginia | |
| Innovative Clinical Research Center | |
| Alexandria, Virginia, United States, 22304 | |
| Canada, British Columbia | |
| The Medical Arts Health Research Group | |
| Penticton, British Columbia, Canada, V2ASC8 | |
| Canada, Nova Scotia | |
| Queen Elizabeth II Health Sciences Centre | |
| Halifax, Nova Scotia, Canada, B3H2E1 | |
| Canada, Ontario | |
| Toronto Memory Program (Neurology Research Inc.) | |
| Toronto, Ontario, Canada, M2J5A3 | |
| Canada, Quebec | |
| Novabyss Inc. | |
| Sherbrooke, Quebec, Canada, J1G2E8 | |
Sponsors and Collaborators
Voyager Pharmaceutical Corporation
Investigators
| Principal Investigator: | Connie Powers | Sr. Clinical Scientist, Voyager Pharmaceutical |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00231946 History of Changes |
| Other Study ID Numbers: | IA0084 |
| Study First Received: | September 30, 2005 |
| Last Updated: | September 18, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Institute on Aging (NIA):
|
gonadotropins hormone therapy HRT Antigonadotropin Leuprolide |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
Leuprolide Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Fertility Agents, Female Fertility Agents Reproductive Control Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013