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| Sponsor: | Voyager Pharmaceutical Corporation |
|---|---|
| Information provided by: | National Institute on Aging (NIA) |
| ClinicalTrials.gov Identifier: | NCT00063310 |
Purpose
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 women leuprolide is commonly used to treat hormone related conditions such as endometriosis and uterine fibroids. The study will include treatment of women 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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation (ALADDIN) |
| Estimated Enrollment: | 90 |
| Study Start Date: | March 2003 |
| Study Completion Date: | February 2006 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
The study will include the treatment of participants with mild to moderate AD, and 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
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who satisfy all of the inclusion criteria listed below will be eligible for entry into the trial. Patients will be considered eligible if:
Exclusion Criteria:
Patients with any of the exclusion criteria listed below will be ineligible for entry into the study. Patients will be declared ineligible if:
Contacts and Locations| United States, Arizona | |
| Sun Health Research Institute | |
| Sun City, Arizona, United States, 85351 | |
| United States, Florida | |
| Baumel-Eisner Neuromedical Institute | |
| Fort Lauderdale, Florida, United States, 33321 | |
| Meridien Research | |
| St. Petersburg, Florida, United States, 33710 | |
| Principal Investigator: | Richard L. Bowen, MD | Voyager Pharmaceutical Corporation |
More Information
| ClinicalTrials.gov Identifier: | NCT00063310 History of Changes |
| Other Study ID Numbers: | IA0047, IND 66,415 |
| Study First Received: | June 25, 2003 |
| Last Updated: | December 10, 2009 |
| Health Authority: | Unspecified |
|
Alzheimer disease Aging Women Hormone therapy |
|
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 |