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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00231946
First received: September 30, 2005
Last updated: September 18, 2007
Last verified: September 2007
History of Changes
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
 Drug: VP4896
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo-Controlled Study of VP4896 For the Treatment of Mild-to-Moderate Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Cognitive assessment and Caregiver's impression of change at baseline and at weeks 8, 24, 34, and 50.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 555
Study Start Date: September 2005
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231946

  Show 59 Study Locations
Sponsors and Collaborators
Voyager Pharmaceutical Corporation
Investigators
Principal Investigator: Connie Powers Sr. Clinical Scientist, Voyager Pharmaceutical
  More Information

Additional Information:
Voyager Pharmaceutical  This link exits the ClinicalTrials.gov site
Alzheimer's Disease Education and Referral Center  This link exits the ClinicalTrials.gov site
Alzheimer's Association  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00231946     History of Changes
Other Study ID Numbers: IA0084
Study First Received: September 30, 2005
Last Updated: September 18, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Aging (NIA):
gonadotropins
hormone therapy
HRT
Antigonadotropin
Leuprolide

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
 Leuprolide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013