Alzheimer Disease
Conditions
Keywords
Alzheimer disease, Aging Women, Hormone therapy
Brief summary
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.
Detailed description
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
Interventions
DRUGLeuprolide acetate
Sponsors
Voyager Pharmaceutical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
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: * They give their consent by signing the IRB-approved Informed Consent Form and the responsible caregiver also signs the consent form; or, if the patient is judged by the Investigator to be unable to give consent, if the legally authorized representative gives consent by signing the consent form and the patient gives assent, in accord with local regulations; * They are female; * They are 65 years of age or older; * They have a diagnosis of probable AD according to the National Institute of Neurological Disorders-Alzheimer's Disease and Related Disorders Association (NINDS-ADRDA) criteria and the Investigator ascertains that the condition was present at least 6 months prior to screening; * They are taking a cholinesterase inhibitor, they began taking it at least 90 days prior to baseline and, in the Investigator's opinion, the dosage will likely remain stable throughout the trial; * They are taking other drugs or substances that have purported cognition enhancing properties such as ginkgo biloba and Vitamin E, they began taking it at least 60 days prior to baseline and, in the Investigator's opinion, the dosage will likely remain stable throughout the trial; * They score no lower than 12 or higher than 24 on the (MMSE) administered at the screening visit; * They have had a brain imaging study (CT scan, MRI or PET) performed at the time of their initial diagnosis of AD or after that time, and the findings were consistent with a diagnosis of probable AD, or, if a brain imaging study has not been performed, one will be performed during the screening process; * Their Rosen Modified Hachinski score was 4 or lower at the screening visit, supporting the Investigator's clinical judgment that the patient's dementia is probable AD and not of vascular origin; * They are fluent in English or Spanish and completed at least 6 years of education; * They live at home or in a congregate living facility for requirements other than skilled nursing care, and have a caregiver who sees the patient at least three time a week for a total of at least 10 hours and can sign the consent form, provide information pertinent to the patient's cognitive status, accompany the patient on clinic visits and participate in the evaluations; * Their hormone replacement therapy (HRT), if any, has been stable for at least 60 days prior to baseline, and is not expected to change during the course of the trial; * They score less than 15 on the Hamilton Depression Scale (17-item version) (HamD) administered as part of the screening evaluation; * Absorptiometry (dual-energy x-ray absorpometry (DEXA) scan), performed at screening, was within normal limits (i.e., a T- score of no less than -2.0); or, if their DEXA measure was abnormally low, they were receiving treatment for osteoporosis for at least 3 weeks and that treatment is not expected to change during the course of the trial; or, if their DEXA measure was abnormally low and they are not receiving treatment for osteoporosis, they may enter the trial after 3 weeks of treatment provided that assessments of the HamD, concomitant medications, ECG tracing and laboratory tests performed within 45 days of baseline show that they are eligible. * values on their screening laboratory tests do not indicate significant medical conditions that would interfere with their participation in and completion of the study
Exclusion criteria
Patients with any of the
Countries
United States
Outcome results
None listed