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Alzheimer DiseasePhase 2NCT00063310

ALADDIN Study: Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation

A Phase 2 study testing Leuprolide acetate in people with Alzheimer Disease, run by Voyager Pharmaceutical Corporation at 3 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 women leuprolide is commonly used to treat hormone related conditions such as endometriosis and uterine fibroids. Read more about this study

Who is it for?
Ages 65 years and older, women only
Conditions the study is for
Alzheimer Disease
What is being tested?
Leuprolide acetate
How many people
90 participants
Where
3 sitesUnited States
Study dates
Mar 2003to Feb 2006
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
  • Women 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. Patients will be considered eligible if:
  • They give their consent by signing the IRB-approved Informed Consent Form and the responsible caregiver also signs the consent form; or, if the patient is judged by the Investigator to be unable to give consent, if the legally authorized representative gives consent by signing the consent form and the patient gives assent, in accord with local regulations;
  • They are female;
  • They are 65 years of age or older;
  • They have a 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;
  • They are taking a cholinesterase inhibitor, they began taking it at least 90 days prior to baseline and, in the Investigator's opinion, the dosage will likely remain stable throughout the trial;
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  • They are taking other drugs or substances that have purported cognition enhancing properties such as ginkgo biloba and Vitamin E, they began taking it at least 60 days prior to baseline and, in the Investigator's opinion, the dosage will likely remain stable throughout the trial;
  • They score no lower than 12 or higher than 24 on the (MMSE) administered at the screening visit;
  • They have had a 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;
  • Their Rosen Modified Hachinski score was 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;
  • They are fluent in English or Spanish and completed at least 6 years of education;
  • They 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 time 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;
  • Their hormone replacement therapy (HRT), if any, has been stable for at least 60 days prior to baseline, and is not expected to change during the course of the trial;
  • They score less than 15 on the Hamilton Depression Scale (17-item version) (HamD) administered as part of the screening evaluation;
  • Absorptiometry (dual-energy x-ray absorpometry (DEXA) scan), performed at screening, was within normal limits (i.e., a T- score of no less than -2.0); or, if their DEXA measure was abnormally low, they were receiving treatment for osteoporosis for at least 3 weeks 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, they may enter the trial after 3 weeks of treatment provided that assessments of the HamD, concomitant medications, ECG tracing and laboratory tests performed within 45 days of baseline show that they are eligible.
  • values on their screening laboratory tests 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. Patients will be declared ineligible if:
  • They are male;
  • They are younger than 65 years of age;
  • They have significant neurological disease affecting the brain or psychiatric disease other than AD, such as major depression, schizophrenia, epilepsy, Parkinson's disease, or stroke;
  • They have current significant systemic illness or symptoms of organ failure;
  • The screening ECG shows evidence of a serious and/or unstable condition or a recent (within 6 months) myocardial infarction;
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  • They have a history of cancer within the last 5 years, except for basal cell or squamous cell cancer, or cervical carcinoma in situ;
  • They are taking a cholinesterase inhibitor (tacrine, donepezil, rivastigmine, or galantamine) 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
  • They have never received cholinesterase inhibitor treatment and are likely to initiate it;
  • They started or changed within 60 days prior to the screening visit the dosage of any drug (including an over the counter drug) 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, non steroidal anti-inflammatory drugs, statins, and hormone replacement therapy, 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 is given on a PRN basis, such treatment should be interrupted for 12 hours before a visit, it at all possible;
  • They are receiving coumadin or anti-Parkinsonian medications;
  • They have received other investigational drugs within 30 days or 5 half-lives prior to randomization, whichever is longer;
  • They are taking other medications known to affect serum gonadotropin (Gn) concentrations, such as goserelin or danazol, except for estrogen and/or progesterone;
  • They have a history of bone fracture possibly secondary to low bone mass density;
  • They have a history of osteoporosis not associated with bone fracture unless they are receiving therapy for osteoporosis for at least 3 weeks, and the treatment regimen is expected to stay stable their DEXA measures were abnormally low (i.e., T-score <-2.0) and they were not receiving treatment for osteoporosis for at least 3 weeks;
  • They have a screening HamD score of 15 or higher;
  • Their abuse or dependence on alcohol or other substances satisfy criteria for DSM-IV categories 303.9 or 305; or
  • They have donated blood within 30 days of baseline or are likely to do so during the course of the trial.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Baumel-Eisner Neuromedical Institute

    Fort Lauderdale, Florida, 33321

  • Meridien Research

    St. Petersburg, Florida, 33710

  • Sun Health Research Institute

    Sun City, Arizona, 85351

Other trials in United States

About this study

Official title: Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation (ALADDIN)

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 women leuprolide is commonly used to treat hormone related conditions such as endometriosis and uterine fibroids. The study will include treatment of women 65 years and older with mild to moderate Alzheimer's disease who reside in the community.

Read the detailed description

The study will include the treatment of participants with mild to moderate AD, and 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

Being tested
Leuprolide acetate
Keywords
Alzheimer disease, Aging Women, Hormone therapy
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 Jun 2003 (estimated)
  2. Study startMar 2003
  3. Primary completionFeb 2006
  4. Study completionFeb 2006

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
NCT00063310
Sponsor's protocol ID
IA0047
Other IDs
IND 66,415
Status last verified
Feb 2006
First submitted
25 Jun 2003
Last updated
11 Dec 2009
Results posted
No

Publications

  • Smith MA, Perry G, Atwood CS, Bowen RL. Estrogen replacement and risk of Alzheimer disease. JAMA. 2003 Mar 5;289(9):1100; author reply 1101-2. doi: 10.1001/jama.289.9.1100-a. No abstract available.

    PubMed 12622570

  • 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

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 3 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 16 inclusion and 18 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 3 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 NCT00063310, 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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