Overview

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