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

Sponsored by:	Voyager Pharmaceutical Corporation
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00231946

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 III

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Leuprolide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Double-Blind Placebo-Controlled Study of VP4896 For the Treatment of Mild-to-Moderate Alzheimer's Disease

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:

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.

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.

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.

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

Keywords provided by National Institute on Aging (NIA):

gonadotropins
hormone therapy
HRT
Antigonadotropin
Leuprolide

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Leuprolide
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Hormones
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009