Alzheimer's DiseasePhase 3NCT00231946
ALADDIN Study - Phase III: Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation (VP-AD-301)
A Phase 3 study testing VP4896 in people with Alzheimer's Disease, run by Voyager Pharmaceutical Corporation at 59 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- VP4896
- How many people
- 555 participants
- Where
- 59 sitesin 2 countries
- Study dates
- Sep 2005to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
59 sites in 2 countries.
59 sites in 2 countries
United States55 sites
Upstate Clinical Research, LLC
Albany, New York, 12205
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, 87102
Innovative Clinical Research Center
Alexandria, Virginia, 22304
Southwestern Vermont Medical Center
Bennington, Vermont, 05201
ICPS Group
Boston, Massachusetts, 02131
Meridien Research
Brookville, Florida, 34613
Ohio State University Medical Center
Columbus, Ohio, 43210
Comprehensive Neuroscience, Inc.
Darien, Connecticut, 06820
Brain Matters Research
Delray Beach, Florida, 33445
Radiant Research
Denver, Colorado, 80212
Colorado Neurology & Headache Center
Denver, Colorado, 80218
Memory Research Institute
East Providence, Rhode Island, 02914
Pharmaceutical Research-Oregon, Inc.
Eugene, Oregon, 97401
Hunterdon Medical Center
Flemington, New Jersey, 08822
Margolin Brain Institute
Fresno, California, 93720
Radiant Research - Greer
Greer, South Carolina, 29651
Geriatric and Adult Psychiatry
Hamden, Connecticut, 06518
Berma Research Group
Hialeah, Florida, 33016
Kuakani Medical Center
Honolulu, Hawaii, 96817
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Clinical Trial Center, LLC.
Jenkintown, Pennsylvania, 19046
Bay Area Research Institute
Lafayette, California, 94549
Anderson Clinical Research
Loma Linda, California, 92354
Pharmacology Research Institute
Los Alamitos, California, 90720
David Trader
Los Angeles, California, 90035
Medark Clinical Trials
Morgantown, North Carolina, 28655
Synergy Clinical Research
National City, California, 91950
Pharmacology Research Institute
Newport Beach, California, 92660
Pearl Clinical Research, Inc.
Norristown, Pennsylvania, 19401
Pharmacology Research Institute
Northridge, California, 91324
North County Neurology Assoc.
Oceanside, California, 92056
IPS Research Company
Oklahoma City, Oklahoma, 73103
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Pivotal Research Centers
Peoria, Arizona, 85381
Neurology Clinical Research, LLC
Plantation, Florida, 33324
Butler Hospital
Providence, Rhode Island, 02906
Norman Gordon, MD
Providence, Rhode Island, 02916
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, 27607
Pharmacology Research Institute
Riverside, California, 92056
Pivotal Research Centers
Royal Oak, Michigan, 48073
Bexar Diagnostic Medicine Associates
San Antonio, Texas, 78229
Pacific Research Network
San Diego, California, 92103
San Francisco Clinical Research Center
San Francisco, California, 94109
Neurological Research Institute
Santa Monica, California, 90404
Roskamp Institute
Sarasota, Florida, 34243
Booker, J. Gary, MD, APMC
Shreveport, Louisiana, 71104
Meridien Research
St. Petersburg, Florida, 33709
Meridien Research
Tampa, Florida, 33609
Neurology Center of Ohio
Toledo, Ohio, 43623
Torrance Clinical Research
Torrance, California, 90505
NeuroSpecialists, PLLC
Tucson, Arizona, 85741
Palm Beach Neurological Group
West Palm Beach, Florida, 33407
Quantum Laboratories
West Palm Beach, Florida, 33409
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103
Canada4 sites
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H2E1
The Medical Arts Health Research Group
Penticton, British Columbia, V2ASC8
Novabyss Inc.
Sherbrooke, Quebec, J1G2E8
Toronto Memory Program (Neurology Research Inc.)
Toronto, Ontario, M2J5A3
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- VP4896
- Keywords
- gonadotropins, hormone therapy, HRT, Antigonadotropin, Leuprolide
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VP4896Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive assessment and Caregiver's impression of change at baseline and at weeks 8, 24, 34, and 50.
Secondary outcomes (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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 555 participants
Sponsor and investigators
- Lead sponsor
- Voyager Pharmaceutical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Connie Powers, Principal investigator, Sr. Clinical Scientist, Voyager Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231946
- Sponsor's protocol ID
- IA0084
- Status last verified
- Sep 2007
- First submitted
- 30 Sep 2005
- Last updated
- 20 Sep 2007
- Results posted
- No
Publications
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.
PubMed 15723167Bowen 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.
PubMed 15331856Bowen 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.
PubMed 14871891Webber 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. doi: 10.55782/ane-2004-1497.
PubMed 15190686Zhu 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.
PubMed 14991845
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Placebo-Controlled Study of VP4896 For the Treatment of Mild-to-Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00231946
- Acronym / sponsor ID
- IA0084
- Conditions
- Alzheimer's Disease
- Keywords
- gonadotropins, hormone therapy, HRT, Antigonadotropin, Leuprolide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 555 participants
- Lead sponsor
- Voyager Pharmaceutical CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- First posted
- 4 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VP4896 | Drug | – |
Primary outcome
Cognitive assessment and Caregiver's impression of change at baseline and at weeks 8, 24, 34, and 50.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2007.
- Background: PubMed 15723167Gregory 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.
- Background: PubMed 15331856Bowen 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.
- Background: PubMed 14871891Bowen 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.
- Background: PubMed 15190686Webber 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. doi: 10.55782/ane-2004-1497.
- Background: PubMed 14991845Zhu 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.
- Alzheimer's Disease Education and Referral CenterLink provided by the sponsor.
- Alzheimer's AssociationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie Powers principal investigator
Sr. Clinical Scientist, Voyager Pharmaceutical
59 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VP4896 in people with Alzheimer's Disease, run by Voyager Pharmaceutical Corporation at 59 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive assessment and Caregiver's impression of change at baseline and at weeks 8, 24, 34, and 50.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00231946, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2007.