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Alzheimer DiseasePhase 2NCT00076440

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

A Phase 2 study testing Leuprolide acetate in people with Alzheimer Disease, run by Voyager Pharmaceutical Corporation at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older, men only
Conditions the study is for
Alzheimer Disease
What is being tested?
Leuprolide acetate
How many people
90 participants
Where
13 sitesUnited States
Study dates
Dec 2003to Mar 2007
Phase
Phase 2
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 65 years and older
  • Men only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patients who satisfy all of the inclusion criteria listed below will be eligible for entry into the trial.
  • 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;
  • 65 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;
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  • 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;
  • DEXA scan, performed at screening, within normal limits (i.e., a T-score of greater than -2.0); or, if their DEXA measure was abnormally low (i.e., a T-score of -2.0 or lower), in either a lumbar vertebra or hip, to specifically include a T-score for the femoral neck), they were receiving treatment for osteoporosis/osteopenia for at least 3 weeks prior to baseline and that treatment is not expected to change during the course of the trial; or, if their DEXA measure was abnormally low and they are not receiving treatment for osteoporosis/osteopenia, they may proceed to baseline after 3 weeks of treatment for osteoporosis/osteopenia provided that all inclusion/exclusion criteria are met, including assessment of the HamD, concomitant medications, ECG and laboratory tests performed within 45 days of baseline show that they are eligible;
  • Screening laboratory test values do not indicate significant medical conditions that would interfere with their participation in and completion of the study.

Who cannot join

  • Patients with any of the exclusion criteria listed below will be ineligible for entry into 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;
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  • 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;
  • Abuse or dependence on alcohol or other substances satisfies criteria for DSM-IV categories 303.9 or 305;
  • Donated blood within 30 days of baseline or are likely to do so during the course of the trial;
  • History of cancer, particularly breast cancer or known or suspected prostate cancer, within the last 5 years, except for basal cell or squamous cell cancer of the skin;
  • Clinically significant bladder outlet obstruction, in the judgment of the Investigator or designated examining physician;
  • Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia, or are unable to stand or sit upright for at least 30 minutes;
  • Sleep apnea.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Innovative Clinical Research Center

    Alexandria, Virginia, 22304

  • Baumel-Eisner Neuromedical Institute

    Boca Raton, Florida, 33486

  • Boston University School of Medicine

    Boston, Massachusetts, 02118-2526

  • Medical University of South Carolina

    Charleston, South Carolina, 29406

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Baumel-Eisner Neuromedical Institute

    Fort Lauderdale, Florida, 33321

  • Margolin Brain Institute

    Fresno, California, 93720

  • Geriatric and Adult Psychiatry LLC

    Hamden, Connecticut, 06518

  • Bay Area Research Institute

    Lafayette, California, 94549

  • Middleton VA Wisconsin Alzheimer's Institute

    Madison, Wisconsin, 53705

  • Baumel-Eisner Neuromedical Institute

    Miami Beach, Florida, 33154

  • Southwest Clinical Research

    Rancho Mirage, California, 92270

  • Meridien Research

    St. Petersburg, Florida, 33710

Other trials in United States

About this study

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.

Read the detailed description

ALADDIN is a clinical trial investigating the safety and effectiveness of leuprolide (a hormone drug) to improve the cognitive function and slow the progression of Alzheimer's disease (AD). The study will include treatment of men 65 years and older with mild to moderate Alzheimer's disease who reside in the community. The objective is to evaluate the safety and efficacy of two different doses of leuprolide to improve the cognitive function and slow the progression of AD, as measured by the ADAS-COG and the Clinical Global Impression (CGI). Measures of behavioral disturbances, and quality of life of the caregiver will be made also. The study design is randomized, double blind, placebo-controlled, parallel group design with a 2:1 randomization of drug to placebo. Sample size will include 90 participants from multiple test sites.

Following initial screening and baseline visits, the participant and caregiver will visit the site 8 times for a total of 10 visits over 48 weeks. The drug is administered via injection every 3 months. Safety assessments are completed and psychometric testing is done. Participant's memory, behavior, and global functioning are assessed during the participant and caregiver interviews. Each visit takes approximately 2 hours.

Being tested
Leuprolide acetate
Keywords
Alzheimer disease
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Leuprolide acetateDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2004 (estimated)
  2. Study startDec 2003
  3. Primary completionMar 2007
  4. Study completionMar 2007

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
90 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00076440
Sponsor's protocol ID
IA0051
Status last verified
Mar 2007
First submitted
22 Jan 2004
Last updated
11 Dec 2009
Results posted
No

Publications

  • 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.

    PubMed 12391612

  • 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.

    PubMed 11560301

  • 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.

    PubMed 10718932

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Leuprolide acetate in people with Alzheimer Disease, run by Voyager Pharmaceutical Corporation at 13 sites in United States.

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 15 inclusion and 21 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 11 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00076440, which also lists 3 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 11 Dec 2009.

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