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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
VP4896
Sponsored by
Voyager Pharmaceutical Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring gonadotropins, hormone therapy, HRT, Antigonadotropin, Leuprolide

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pivotal Research Centers
  • NeuroSpecialists, PLLC
  • Margolin Brain Institute
  • Bay Area Research Institute
  • Anderson Clinical Research
  • Pharmacology Research Institute
  • David Trader
  • Synergy Clinical Research
  • Pharmacology Research Institute
  • Pharmacology Research Institute
  • North County Neurology Assoc.
  • Pharmacology Research Institute
  • Pacific Research Network
  • San Francisco Clinical Research Center
  • Neurological Research Institute
  • Torrance Clinical Research
  • Radiant Research
  • Colorado Neurology & Headache Center
  • Comprehensive Neuroscience, Inc.
  • Geriatric and Adult Psychiatry
  • Meridien Research
  • Brain Matters Research
  • Berma Research Group
  • Neurology Clinical Research, LLC
  • Roskamp Institute
  • Meridien Research
  • Meridien Research
  • Palm Beach Neurological Group
  • Quantum Laboratories
  • Kuakani Medical Center
  • Booker, J. Gary, MD, APMC
  • ICPS Group
  • Pivotal Research Centers
  • University of Nebraska Medical Center
  • Hunterdon Medical Center
  • Albuquerque Neuroscience Inc.
  • Upstate Clinical Research, LLC
  • Medark Clinical Trials
  • Raleigh Neurology Associates, P.A.
  • Piedmont Medical Research Associates
  • Ohio State University Medical Center
  • Neurology Center of Ohio
  • IPS Research Company
  • Pharmaceutical Research-Oregon, Inc.
  • Clinical Trial Center, LLC.
  • Pearl Clinical Research, Inc.
  • Memory Research Institute
  • Butler Hospital
  • Norman Gordon, MD
  • Radiant Research - Greer
  • University of Texas Health Science Center at Houston
  • Bexar Diagnostic Medicine Associates
  • Grayline Clinical Drug Trials
  • Southwestern Vermont Medical Center
  • Innovative Clinical Research Center
  • The Medical Arts Health Research Group
  • Queen Elizabeth II Health Sciences Centre
  • Toronto Memory Program (Neurology Research Inc.)
  • Novabyss Inc.

Outcomes

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.

Full Information

First Posted
September 30, 2005
Last Updated
September 18, 2007
Sponsor
Voyager Pharmaceutical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00231946
Brief Title
ALADDIN Study - Phase III: Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation (VP-AD-301)
Official Title
A Double-Blind Placebo-Controlled Study of VP4896 For the Treatment of Mild-to-Moderate Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Voyager Pharmaceutical Corporation

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
gonadotropins, hormone therapy, HRT, Antigonadotropin, Leuprolide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
555 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
VP4896
Primary Outcome Measure Information:
Title
Cognitive assessment and Caregiver's impression of change at baseline and at weeks 8, 24, 34, and 50.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie Powers
Organizational Affiliation
Sr. Clinical Scientist, Voyager Pharmaceutical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pivotal Research Centers
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
NeuroSpecialists, PLLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Margolin Brain Institute
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Bay Area Research Institute
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Facility Name
Anderson Clinical Research
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
David Trader
City
Los Angeles
State/Province
California
ZIP/Postal Code
90035
Country
United States
Facility Name
Synergy Clinical Research
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Pharmacology Research Institute
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
North County Neurology Assoc.
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Pharmacology Research Institute
City
Riverside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Pacific Research Network
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Neurological Research Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Torrance Clinical Research
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Radiant Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80212
Country
United States
Facility Name
Colorado Neurology & Headache Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Comprehensive Neuroscience, Inc.
City
Darien
State/Province
Connecticut
ZIP/Postal Code
06820
Country
United States
Facility Name
Geriatric and Adult Psychiatry
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Meridien Research
City
Brookville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Berma Research Group
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Neurology Clinical Research, LLC
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Roskamp Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Meridien Research
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Palm Beach Neurological Group
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Quantum Laboratories
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Kuakani Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Booker, J. Gary, MD, APMC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
ICPS Group
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Pivotal Research Centers
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Hunterdon Medical Center
City
Flemington
State/Province
New Jersey
ZIP/Postal Code
08822
Country
United States
Facility Name
Albuquerque Neuroscience Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Upstate Clinical Research, LLC
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Medark Clinical Trials
City
Morgantown
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Raleigh Neurology Associates, P.A.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Piedmont Medical Research Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Neurology Center of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Pharmaceutical Research-Oregon, Inc.
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Clinical Trial Center, LLC.
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Pearl Clinical Research, Inc.
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
Memory Research Institute
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Norman Gordon, MD
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02916
Country
United States
Facility Name
Radiant Research - Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Bexar Diagnostic Medicine Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Grayline Clinical Drug Trials
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Southwestern Vermont Medical Center
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Innovative Clinical Research Center
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
The Medical Arts Health Research Group
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2ASC8
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2E1
Country
Canada
Facility Name
Toronto Memory Program (Neurology Research Inc.)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2J5A3
Country
Canada
Facility Name
Novabyss Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G2E8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
15723167
Citation
Gregory CW, Bowen RL. Novel therapeutic strategies for Alzheimer's disease based on the forgotten reproductive hormones. Cell Mol Life Sci. 2005 Feb;62(3):313-9. doi: 10.1007/s00018-004-4386-y.
Results Reference
background
PubMed Identifier
15331856
Citation
Bowen RL, Atwood CS. Living and dying for sex. A theory of aging based on the modulation of cell cycle signaling by reproductive hormones. Gerontology. 2004 Sep-Oct;50(5):265-90. doi: 10.1159/000079125.
Results Reference
background
PubMed Identifier
14871891
Citation
Bowen RL, Verdile G, Liu T, Parlow AF, Perry G, Smith MA, Martins RN, Atwood CS. Luteinizing hormone, a reproductive regulator that modulates the processing of amyloid-beta precursor protein and amyloid-beta deposition. J Biol Chem. 2004 May 7;279(19):20539-45. doi: 10.1074/jbc.M311993200. Epub 2004 Feb 9.
Results Reference
background
PubMed Identifier
15190686
Citation
Webber KM, Bowen R, Casadesus G, Perry G, Atwood CS, Smith MA. Gonadotropins and Alzheimer's disease: the link between estrogen replacement therapy and neuroprotection. Acta Neurobiol Exp (Wars). 2004;64(1):113-8.
Results Reference
background
PubMed Identifier
14991845
Citation
Zhu X, McShea A, Harris PL, Raina AK, Castellani RJ, Funk JO, Shah S, Atwood C, Bowen R, Bowser R, Morelli L, Perry G, Smith MA. Elevated expression of a regulator of the G2/M phase of the cell cycle, neuronal CIP-1-associated regulator of cyclin B, in Alzheimer's disease. J Neurosci Res. 2004 Mar 1;75(5):698-703. doi: 10.1002/jnr.20028.
Results Reference
background
Links:
URL
http://voyagerpharma.com
Description
Voyager Pharmaceutical
URL
http://www.alzheimers.org
Description
Alzheimer's Disease Education and Referral Center
URL
http://www.alz.org
Description
Alzheimer's Association

Learn more about this trial

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

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