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CompletedPhase 3

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

A Double-Blind Placebo-Controlled Study of VP4896 For the Treatment of Mild-to-Moderate Alzheimer's Disease

Lead sponsor

Voyager Pharmaceutical Corporation

Asset

VP4896

Listed sites

Recruiting sites

Enrollment

555

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•AD symptomatic therapy: stable

Primary endpoint

•Cognitive assessment and Caregiver's impression of change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDIA0084

NCT IDNCT00231946

Timeline

Milestones

Study start2005-09 (month precision)

Study first posted2005-10-04estimated

Last update posted2007-09-20estimated

Assets

Drug assets

VP4896

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Global cognition

1 endpoint

Primary/protocol endpoint

Cognitive assessment and Caregiver's impression of change at baseline and at weeks 8, 24, 34, and 50.

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

Ability to perform Activities of Daily Living (ADL) at baseline and weeks 8, 24, 34, and 50. Impression of disease severity assessment at week 50.

descriptive

Publications (5)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.