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Sponsored by: |
Voyager Pharmaceutical Corporation |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00076440 |
ALADDIN is a research study to investigate the safety and effectiveness of leuprolide (a hormone drug) to improve the cognitive function and slow the progression of Alzheimer's disease (AD) in men 65 years and older with mild to moderate Alzheimer's disease who reside in the community.
Condition | Intervention | Phase |
---|---|---|
Alzheimer Disease |
Drug: Leuprolide acetate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation (ALADDIN) VP 104 Study |
Estimated Enrollment: | 90 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | May 2006 |
ALADDIN is a clinical trial investigating the safety and effectiveness of leuprolide (a hormone drug) to improve the cognitive function and slow the progression of Alzheimer's disease (AD). The study will include treatment of men 65 years and older with mild to moderate Alzheimer's disease who reside in the community. The objective is to evaluate the safety and efficacy of two different doses of leuprolide to improve the cognitive function and slow the progression of AD, as measured by the ADAS-COG and the Clinical Global Impression (CGI). Measures of behavioral disturbances, and quality of life of the caregiver will be made also. The study design is randomized, double blind, placebo-controlled, parallel group design with a 2:1 randomization of drug to placebo. Sample size will include 90 participants from multiple test sites.
Following initial screening and baseline visits, the participant and caregiver will visit the site 8 times for a total of 10 visits over 48 weeks. The drug is administered via injection every 3 months. Safety assessments are completed and psychometric testing is done. Participant's memory, behavior, and global functioning are assessed during the participant and caregiver interviews. Each visit takes approximately 2 hours.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who satisfy all of the inclusion criteria listed below will be eligible for entry into the trial.
Exclusion criteria:
Patients with any of the exclusion criteria listed below will be ineligible for entry into the study.
United States, California | |
Bay Area Research Institute | |
Lafayette, California, United States, 94549 | |
Southwest Clinical Research | |
Rancho Mirage, California, United States, 92270 | |
Margolin Brain Institute | |
Fresno, California, United States, 93720 | |
United States, Connecticut | |
Geriatric and Adult Psychiatry LLC | |
Hamden, Connecticut, United States, 06518 | |
United States, Florida | |
Baumel-Eisner Neuromedical Institute | |
Ft. Lauderdale, Florida, United States, 33321 | |
Baumel-Eisner Neuromedical Institute | |
Boca Raton, Florida, United States, 33486 | |
Baumel-Eisner Neuromedical Institute | |
Miami Beach, Florida, United States, 33154 | |
Meridien Research | |
St. Petersburg, Florida, United States, 33710 | |
Brain Matters Research | |
Delray Beach, Florida, United States, 33445 | |
United States, Massachusetts | |
Boston University School of Medicine | |
Boston, Massachusetts, United States, 02118-2526 | |
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29406 | |
United States, Virginia | |
Innovative Clinical Research Center | |
Alexandria, Virginia, United States, 22304 | |
United States, Wisconsin | |
Middleton VA Wisconsin Alzheimer's Institute | |
Madison, Wisconsin, United States, 53705 |
Principal Investigator: | Richard L. Bowen, MD | Voyager Pharmaceutical Corporation |
Study ID Numbers: | IA0051 |
Study First Received: | January 22, 2004 |
Last Updated: | March 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00076440 |
Health Authority: | United States: Food and Drug Administration |
Alzheimer disease |
Delirium, Dementia, Amnestic, Cognitive Disorders Leuprolide Mental Disorders Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Antineoplastic Agents, Hormonal Antineoplastic Agents Fertility Agents, Female Therapeutic Uses Physiological Effects of Drugs |
Fertility Agents Nervous System Diseases Reproductive Control Agents Tauopathies Pharmacologic Actions |