ALADDIN Study - Phase III: Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation (VP-AD-301)
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 |
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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
Outcome Measures
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. []
Eligibility Criteria
Criteria
Inclusion Criteria:
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60 years of age or older
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Diagnosis of probable mild-to-moderate Alzheimer's Disease
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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
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No other significant or interfering medical conditions
Exclusion Criteria:
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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
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Laboratory or clinical signs of untreated, clinically significant abnormal thyroid function, in the Investigator's opinion
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Received other investigational drugs within 30 days or 5 half-lives prior to baseline, whichever is longer
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Taking other medications, with the exception of estrogen, known to affect serum gonadotropin (Gn) concentrations, including but not limited to goserelin, danazol, or leuprolide
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Other exclusion criteria exist--eligibility can be assessed by the trial site
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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
- 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. Review.
- 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. Epub 2004 Feb 9.
- 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. Review.
- 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. Review.
- 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.
- IA0084