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

Sponsor
Voyager Pharmaceutical Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00231946
Collaborator
(none)
555
59
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Double-Blind Placebo-Controlled Study of VP4896 For the Treatment of Mild-to-Moderate Alzheimer's Disease
Study Start Date :
Sep 1, 2005

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Pivotal Research Centers Peoria Arizona United States 85381
2 NeuroSpecialists, PLLC Tucson Arizona United States 85741
3 Margolin Brain Institute Fresno California United States 93720
4 Bay Area Research Institute Lafayette California United States 94549
5 Anderson Clinical Research Loma Linda California United States 92354
6 Pharmacology Research Institute Los Alamitos California United States 90720
7 David Trader Los Angeles California United States 90035
8 Synergy Clinical Research National City California United States 91950
9 Pharmacology Research Institute Newport Beach California United States 92660
10 Pharmacology Research Institute Northridge California United States 91324
11 North County Neurology Assoc. Oceanside California United States 92056
12 Pharmacology Research Institute Riverside California United States 92056
13 Pacific Research Network San Diego California United States 92103
14 San Francisco Clinical Research Center San Francisco California United States 94109
15 Neurological Research Institute Santa Monica California United States 90404
16 Torrance Clinical Research Torrance California United States 90505
17 Radiant Research Denver Colorado United States 80212
18 Colorado Neurology & Headache Center Denver Colorado United States 80218
19 Comprehensive Neuroscience, Inc. Darien Connecticut United States 06820
20 Geriatric and Adult Psychiatry Hamden Connecticut United States 06518
21 Meridien Research Brookville Florida United States 34613
22 Brain Matters Research Delray Beach Florida United States 33445
23 Berma Research Group Hialeah Florida United States 33016
24 Neurology Clinical Research, LLC Plantation Florida United States 33324
25 Roskamp Institute Sarasota Florida United States 34243
26 Meridien Research St. Petersburg Florida United States 33709
27 Meridien Research Tampa Florida United States 33609
28 Palm Beach Neurological Group West Palm Beach Florida United States 33407
29 Quantum Laboratories West Palm Beach Florida United States 33409
30 Kuakani Medical Center Honolulu Hawaii United States 96817
31 Booker, J. Gary, MD, APMC Shreveport Louisiana United States 71104
32 ICPS Group Boston Massachusetts United States 02131
33 Pivotal Research Centers Royal Oak Michigan United States 48073
34 University of Nebraska Medical Center Omaha Nebraska United States 68198
35 Hunterdon Medical Center Flemington New Jersey United States 08822
36 Albuquerque Neuroscience Inc. Albuquerque New Mexico United States 87102
37 Upstate Clinical Research, LLC Albany New York United States 12205
38 Medark Clinical Trials Morgantown North Carolina United States 28655
39 Raleigh Neurology Associates, P.A. Raleigh North Carolina United States 27607
40 Piedmont Medical Research Associates Winston-Salem North Carolina United States 27103
41 Ohio State University Medical Center Columbus Ohio United States 43210
42 Neurology Center of Ohio Toledo Ohio United States 43623
43 IPS Research Company Oklahoma City Oklahoma United States 73103
44 Pharmaceutical Research-Oregon, Inc. Eugene Oregon United States 97401
45 Clinical Trial Center, LLC. Jenkintown Pennsylvania United States 19046
46 Pearl Clinical Research, Inc. Norristown Pennsylvania United States 19401
47 Memory Research Institute East Providence Rhode Island United States 02914
48 Butler Hospital Providence Rhode Island United States 02906
49 Norman Gordon, MD Providence Rhode Island United States 02916
50 Radiant Research - Greer Greer South Carolina United States 29651
51 University of Texas Health Science Center at Houston Houston Texas United States 77030
52 Bexar Diagnostic Medicine Associates San Antonio Texas United States 78229
53 Grayline Clinical Drug Trials Wichita Falls Texas United States 76309
54 Southwestern Vermont Medical Center Bennington Vermont United States 05201
55 Innovative Clinical Research Center Alexandria Virginia United States 22304
56 The Medical Arts Health Research Group Penticton British Columbia Canada V2ASC8
57 Queen Elizabeth II Health Sciences Centre Halifax Nova Scotia Canada B3H2E1
58 Toronto Memory Program (Neurology Research Inc.) Toronto Ontario Canada M2J5A3
59 Novabyss Inc. Sherbrooke Quebec Canada J1G2E8

Sponsors and Collaborators

  • Voyager Pharmaceutical Corporation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00231946
Other Study ID Numbers:
  • IA0084
First Posted:
Oct 4, 2005
Last Update Posted:
Sep 20, 2007
Last Verified:
Sep 1, 2007
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 20, 2007