Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation (ALADDIN) VP 104 Study

NCT00076440 | Completed Phase 2

• 1 other identifier: IA0051
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 13

Brief Summary

ALADDIN is a research study to investigate the safety and effectiveness of leuprolide (a hormone drug) to improve the cognitive function and slow the progression of Alzheimer's disease (AD) in men 65 years and older with mild to moderate Alzheimer's disease who reside in the community.

Conditions

Alzheimer Disease

Keywords

Alzheimer disease

Interventions

Leuprolide acetate DRUG

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient and responsible caregiver can give their consent by signing the IRB-approved Informed Consent Form; or, when the patient is judged by the Investigator to be unable to give consent, the legally authorized representative gives consent by signing the consent form and the patient gives assent, in accord with local regulations;
• Male;
• years of age or older;
• Diagnosis of probable AD according to the National Institute of Neurological Disorders-Alzheimer's Disease and Related Disorders Association (NINDS-ADRDA) criteria, and the Investigator ascertains that the condition was present at least 6 months prior to screening;
• Taking a drug for the treatment of AD, such as a cholinesterase inhibitor and/or Memantine®, which they began taking at least 90 days prior to baseline and, in the Investigator's opinion, the dosage will likely remain stable throughout the trial; or, they have never taken such a drug or stopped taking it at least 90 days prior to baseline and will likely refrain from taking such treatment throughout the trial;
• Taking other drugs or substances that have purported cognition-enhancing properties such as ginkgo biloba or Vitamin E, which they began taking at least 60 days prior to baseline and, in the Investigator's opinion, the dosage will likely remain stable throughout the trial; or, they have never taken such a drug or stopped taking it at least 90 days prior to baseline and will likely refrain from taking such treatment throughout the trial;
• Mini Mental State Examination (MMSE) score of 12 to 24 (inclusive) at the screening visit;
• Brain imaging study (CT scan, MRI or PET) performed at the time of their initial diagnosis of AD or after that time, and the findings were consistent with a diagnosis of probable AD, or, if a brain imaging study has not been performed, one will be performed during the screening process;
• Rosen Modified Hachinski score of 4 or lower at the screening visit, supporting the Investigator's clinical judgment that the patient's dementia is probable AD and not of vascular origin;
• Fluent in English or Spanish and completed at least 6 years of education;
• Live at home or in a congregate living facility for requirements other than skilled nursing care, and have a caregiver who sees the patient at least three times a week for a total of at least 10 hours and can sign the consent form, provide information pertinent to the patient's cognitive status, accompany the patient on clinic visits, and participate in the evaluations.
• Hamilton Depression Scale (17-item version) (HamD) score of 14 or less at the screening visit;

You may not qualify if:

• Screening laboratory test values do not indicate significant medical conditions that would interfere with their participation in and completion of the study.
• Female;
• Younger than 65 years of age;
• Significant neurological disease affecting the brain or psychiatric disease other than AD, such as major depression, schizophrenia, epilepsy, Parkinson's disease, or stroke;
• Current significant systemic illness or symptoms of organ failure;
• Screening ECG shows evidence of a serious and/or unstable condition or a recent (within 6 months) myocardial infarction as determined by the Investigator;
• PSA test result exceeds 4.0 ng/mL;
• Receiving testosterone;
• Taking a drug for the treatment of AD for less than 90 days prior to baseline; or, in the opinion of the Investigator, they are likely to either require a change in dose or discontinuation of the drug;
• Never received cholinesterase inhibitor treatment, and the likelihood of their starting such treatment during the study is other than low, or they have taken and discontinued cholinesterase inhibitor treatment in the past and the likelihood of their resuming cholinesterase inhibitor treatment during the study is other than low;
• Started or changed within 60 days prior to the screening visit the dosage of any drug (including OTC) that affects cognitive function, such as neuroleptics, antidepressants, anxiolytics, sedatives, hypnotics, anti-convulsants, centrally acting antihypertensive agents such as clonidine and Aldomet; or other medications that have been shown to have possible effects on cognition such as Vitamin E, nonsteroidal anti-inflammatory drugs, and statins, or if, in the Investigator's opinion, the dosage of such medication is likely to be changed during the course of this trial. Any changes in the dosage of any of these drugs during the course of the trial and the reason for the change must be fully recorded in the concomitant medication page of the patient's case report form (CRF). If a drug that affects cognition (e.g., a hypnotic or anxiolytic drug) is given on a PRN basis, such treatment should be interrupted for 12 hours before a visit, if possible;
• Taking coumadin or anti-Parkinsonian medications;
• Have taken other investigational drugs within 30 days or 5 half-lives prior to randomization, whichever is longer;
• Taking other medications known to affect serum gonadotropin (Gn) concentrations, such as goserelin or danazol;
• A screening HamD score of 15 or higher;

Sponsors & Collaborators

• Voyager Pharmaceutical Corporation: lead

Study Sites (13)

Margolin Brain Institute

Fresno, California, 93720, United States

Location

Bay Area Research Institute

Lafayette, California, 94549, United States

Location

Southwest Clinical Research

Rancho Mirage, California, 92270, United States

Location

Geriatric and Adult Psychiatry LLC

Hamden, Connecticut, 06518, United States

Location

Baumel-Eisner Neuromedical Institute

Boca Raton, Florida, 33486, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Baumel-Eisner Neuromedical Institute

Fort Lauderdale, Florida, 33321, United States

Location

Baumel-Eisner Neuromedical Institute

Miami Beach, Florida, 33154, United States

Location

Meridien Research

St. Petersburg, Florida, 33710, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118-2526, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29406, United States

Location

Innovative Clinical Research Center

Alexandria, Virginia, 22304, United States

Location

Middleton VA Wisconsin Alzheimer's Institute

Madison, Wisconsin, 53705, United States

Location

Related Publications (3)

• Bowen RL, Smith MA, Harris PL, Kubat Z, Martins RN, Castellani RJ, Perry G, Atwood CS. Elevated luteinizing hormone expression colocalizes with neurons vulnerable to Alzheimer's disease pathology. J Neurosci Res. 2002 Nov 1;70(3):514-8. doi: 10.1002/jnr.10452.

  PMID: 12391612 BACKGROUND

• Short RA, Bowen RL, O'Brien PC, Graff-Radford NR. Elevated gonadotropin levels in patients with Alzheimer disease. Mayo Clin Proc. 2001 Sep;76(9):906-9. doi: 10.4065/76.9.906.

  PMID: 11560301 BACKGROUND

• Bowen RL, Isley JP, Atkinson RL. An association of elevated serum gonadotropin concentrations and Alzheimer disease? J Neuroendocrinol. 2000 Apr;12(4):351-4. doi: 10.1046/j.1365-2826.2000.00461.x.

  PMID: 10718932 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Richard L. Bowen, MD

  Voyager Pharmaceutical Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 22, 2004
• First Posted: January 26, 2004
• Study Start: December 1, 2003
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: December 11, 2009

Record last verified: 2007-03

Locations

US (13)