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

September 18, 2007 updated by: Voyager Pharmaceutical Corporation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

VP4896 is a gonadotropin releasing hormone (GnRH) agonist that binds to and inactivates GnRH receptors on the pituitary gland. This decreases the amount of luteinizing hormone released by the pituitary. The hypothesis upon which this trial is designed is that luteinizing hormone is the cause of Alzheimer's disease. VP4896 decreases the amount of luteinizing hormone in the body and, therefore, may decrease or halt the progression of Alzheimer's disease.

This is a double-blind, placebo-controlled, study designed to assess the safety and efficacy of VP4896 (a novel formulation of leuprolide acetate) in the treatment of subjects with mild-to-moderate AD. The study duration is 56 weeks. Approximately 555 participants will be recruited from approximately 80 sites in the United States, Canada, and South America.

The study drug will be administered every eight weeks over a 48 week period. Male subjects randomized to active treatment will also receive testosterone replacement gel.

The change from baseline in ADAS-Cog (cognitive test) score at Week 50 and ADCS-CGIC (global cognitive and behavioral measure) at Week 50 will be the primary efficacy endpoints. Safety will be assessed at all visits and by phone at Week 1.

Study Type

Interventional

Enrollment

555

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Penticton, British Columbia, Canada, V2ASC8
        • The Medical Arts Health Research Group
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H2E1
        • Queen Elizabeth II Health Sciences Centre
    • Ontario
      • Toronto, Ontario, Canada, M2J5A3
        • Toronto Memory Program (Neurology Research Inc.)
    • Quebec
      • Sherbrooke, Quebec, Canada, J1G2E8
        • Novabyss Inc.
  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Pivotal Research Centers
      • Tucson, Arizona, United States, 85741
        • NeuroSpecialists, PLLC
    • California
      • Fresno, California, United States, 93720
        • Margolin Brain Institute
      • Lafayette, California, United States, 94549
        • Bay Area Research Institute
      • Loma Linda, California, United States, 92354
        • Anderson Clinical Research
      • Los Alamitos, California, United States, 90720
        • Pharmacology Research Institute
      • Los Angeles, California, United States, 90035
        • David Trader
      • National City, California, United States, 91950
        • Synergy Clinical Research
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Institute
      • Northridge, California, United States, 91324
        • Pharmacology Research Institute
      • Oceanside, California, United States, 92056
        • North County Neurology Assoc.
      • Riverside, California, United States, 92056
        • Pharmacology Research Institute
      • San Diego, California, United States, 92103
        • Pacific Research Network
      • San Francisco, California, United States, 94109
        • San Francisco Clinical Research Center
      • Santa Monica, California, United States, 90404
        • Neurological Research Institute
      • Torrance, California, United States, 90505
        • Torrance Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80212
        • Radiant Research
      • Denver, Colorado, United States, 80218
        • Colorado Neurology & Headache Center
    • Connecticut
      • Darien, Connecticut, United States, 06820
        • Comprehensive NeuroScience, Inc.
      • Hamden, Connecticut, United States, 06518
        • Geriatric and Adult Psychiatry
    • Florida
      • Brookville, Florida, United States, 34613
        • Meridien Research
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research
      • Hialeah, Florida, United States, 33016
        • Berma Research Group
      • Plantation, Florida, United States, 33324
        • Neurology Clinical Research, LLC
      • Sarasota, Florida, United States, 34243
        • Roskamp Institute
      • St. Petersburg, Florida, United States, 33709
        • Meridien Research
      • Tampa, Florida, United States, 33609
        • Meridien Research
      • West Palm Beach, Florida, United States, 33407
        • Palm Beach Neurological Group
      • West Palm Beach, Florida, United States, 33409
        • Quantum Laboratories
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Kuakani Medical Center
    • Louisiana
      • Shreveport, Louisiana, United States, 71104
        • Booker, J. Gary, MD, APMC
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • ICPS Group
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Pivotal Research Centers
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • Hunterdon Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Neuroscience Inc.
    • New York
      • Albany, New York, United States, 12205
        • Upstate Clinical Research, LLC
    • North Carolina
      • Morgantown, North Carolina, United States, 28655
        • Medark Clinical Trials
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates, P.A.
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Medical Research Associates
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
      • Toledo, Ohio, United States, 43623
        • Neurology Center Of Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research Company
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pharmaceutical Research-Oregon, Inc.
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • Clinical Trial Center, LLC.
      • Norristown, Pennsylvania, United States, 19401
        • Pearl Clinical Research, Inc.
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Memory Research Institute
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital
      • Providence, Rhode Island, United States, 02916
        • Norman Gordon, MD
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Radiant Research - Greer
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston
      • San Antonio, Texas, United States, 78229
        • Bexar Diagnostic Medicine Associates
      • Wichita Falls, Texas, United States, 76309
        • Grayline Clinical Drug Trials
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Southwestern Vermont Medical Center
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Innovative Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Voyager Pharmaceutical Corporation

Investigators

  • Principal Investigator: Connie Powers, Sr. Clinical Scientist, Voyager Pharmaceutical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Registration Dates

First Submitted

September 30, 2005

First Submitted That Met QC Criteria

September 30, 2005

First Posted (ESTIMATE)

October 4, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 20, 2007

Last Update Submitted That Met QC Criteria

September 18, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IA0084

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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