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Trial · Interventional

CompletedPhase 3Registry data

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

This trial does not test a peptide that PepBank tracks.

  • Measures Leuprolide, does not give it. It appears in the eligibility rules.

Overview

Status
Completed
Phase
Phase 3
Enrollment
555 participants
Sponsor
Voyager Pharmaceutical Corporation · Industry
Design
Randomized · Double masking
Countries
2 countries

United States, Canada

Start
Sept 2005
Primary completion
Not stated
Completion
Not stated
First posted
4 Oct 2005 (estimated)
Last update posted
20 Sept 2007 (estimated)
Conditions
Alzheimer's Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20052006
  1. Ph 3

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

    NCT00231946

    Start Sept 2005

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • VP4896Drug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

Secondary outcomes(1)
  1. 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2004

2 results

Luteinizing hormone, a reproductive regulator that modulates the processing of amyloid-beta precursor protein and amyloid-beta deposition.

Bowen et al. 2004The Journal of biological chemistrycited by 127

PMID 14871891DOI 10.1074/jbc.m311993200PUB-14871891

Full text at the publisher2 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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