ALADDIN Study - Phase III: Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation (VP-AD-301)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to investigate the activity of the hormone drug leuprolide acetate in stabilizing cognitive function in mild-to-moderate AD patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Voyager Pharmaceutical Corporation
• Treatments: Leuprolide

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