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The LUCINDA Trial: LUpron Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's (LUCINDA)

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ClinicalTrials.gov Identifier: NCT03649724
Recruitment Status : Not yet recruiting
First Posted : August 28, 2018
Last Update Posted : September 30, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
The LUCINDA Trial is a Phase II, Randomized, Double-Blind Placebo-Controlled Study of Leuprolide Acetate Depot (Lupron) in Female Subjects with Alzheimer's Disease Taking a Stable Dose of an Acetylcholinesterase Inhibitor. It's objective is to assess the efficacy of a 48-week regimen of Lupron (22.5 mg per 12 weeks) compared to placebo on cognitive function, global function and serum and neuroimaging biomarkers in women with Alzheimer's disease (AD) who are also taking a cholinesterase inhibitor.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Placebo Drug: LUPRON DEPOT 22.5 mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The LUCINDA Trial: LUpron Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2026


Arm Intervention/treatment
Placebo Comparator: Placebo
1.5 cc of 0.9% Sterile Sodium Chloride Injection, USP, administered with a 12 cc single-use syringe with a 21-gauge needle.
Drug: Placebo
Placebo injections will consist of 1.5 cc of 0.9% Sterile Sodium Chloride Injection, USP, administered with a 12 cc single-use syringe with a 21-gauge needle.

Experimental: Lupron
Lupron 22.5mg intramuscularly / 3 months
Drug: LUPRON DEPOT 22.5 mg
LUPRON DEPOT 22.5 mg (or placebo) will be administered intramuscularly, in accord with manufacturer's direction, once every twelve weeks for 48 weeks.




Primary Outcome Measures :
  1. Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale [ Time Frame: Baseline, 48 Weeks ]
    The 13-item (ADAS-Cog-13) scoring ranges from 0 to 85, increasing with the severity of dementia.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female, post-menopausal
  • Probable AD according to NIA-AA criteria41
  • Amyloid PET performed at baseline visit interpreted as "amyloid present" by a board certified nuclear medicine physician42
  • Taking a stable dose of the AChEI donepezil for at least 90 days prior to baseline, and dosage likely to remain stable throughout the trial
  • Stable doses of any other medication (e.g memantine), supplement or medical food that may affect brain function
  • MMSE32 12-24 (inclusive) at screening visit
  • Hachinski score43 <5 supporting clinical judgment that dementia is not of vascular origin
  • Fluent in English or Spanish
  • Living at home or in a facility other than a nursing home with 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, accompany the patient on clinic visits, and participate in evaluations

Exclusion Criteria:

  • Presence based on exam, history or MRI of significant brain disease other than AD such as schizophrenia, epilepsy, Parkinson's disease or large territory stroke
  • Current substance abuse in accord with DSM V criteria
  • Significantly depressed (Geriatric Depression Scale44 > 10)
  • Physical or psychological MRI contraindications, or likely unable to tolerate neuroimaging
  • Taking other medications known to affect serum sex hormone or gonadotropin concentrations such as estrogen and/or progesterone for hormone replacement therapy, goserelin or danazol
  • Presence of significant systemic illness likely to interfere with participation in or completion of the study or to affect study results such as cancer within 5 years (other than non-melanoma skin cancer), autoimmune disease, recent myocardial infarction, signs/symptoms of organ failure based on history, ECG, screening laboratory and/or physical exams
  • Receiving other investigational drugs within 30 days or 5 half-lives prior to randomization, whichever is longer
  • Ever treated with active or passive immunization as part of a different clinical trial for AD due to unknown alterations in systemic and brain inflammation, which may confound results

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649724


Contacts
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Contact: Tom Maloney, PhD 646-962-8502 trm4001@med.cornell.edu

Locations
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United States, New York
Weill Medical College of Cornell University Not yet recruiting
New York, New York, United States, 10021
Contact: Tom Maloney, PhD    646-962-8502    trm4001@med.cornell.edu   
Principal Investigator: Tracy A Butler, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Tracy A Butler, MD Weill Medical College of Cornell University

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03649724     History of Changes
Other Study ID Numbers: 057681
R01AG057681-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The data and resources sharing plan for this project is in accordance with both Weill Cornell and NIH Data Sharing Policies. All raw clinical, genetic, and imaging data from this project will be available upon written request. Deidentified neuroimaging data may be uploaded to one or more of several available data sharing sites designed for this purpose. The final data will be available in acceptable formats such as presentations and publications.

Research data and results that document and support the study aims will be available after the final results are accepted for publication. The data to be shared will be anonymized and there will be no fees or other restrictions.

Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Baseline, 48 Weeks
Access Criteria: Approval from PI

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents