The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's (LUCINDA)
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ClinicalTrials.gov Identifier: NCT03649724 |
Recruitment Status :
Recruiting
First Posted : August 28, 2018
Last Update Posted : August 2, 2021
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer Disease Mild Cognitive Impairment | Drug: Placebo Drug: Eligard 22.5Mg Suspension for Injection | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 180 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's |
Actual Study Start Date : | November 27, 2020 |
Estimated Primary Completion Date : | February 2025 |
Estimated Study Completion Date : | February 2026 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
0.25 ml of sterile normal saline administered subcutaneously / 12 weeks
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Drug: Placebo
Placebo (0.25 ml normal saline) will be administered subcutaneously once every twelve weeks for 48 weeks. |
Experimental: Leuprolide
Eligard 22.5mg administered subcutaneously / 12 weeks
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Drug: Eligard 22.5Mg Suspension for Injection
Eligard 22.5Mg Suspension for Injection will be administered subcutaneously, in accord with manufacturer's direction, once every twelve weeks for 48 weeks. |
- Percent change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog-11) [ Time Frame: Baseline, 48 Weeks ]The ADAS-cog-11 consists of 11 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of Alzheimer's Disease.
- Percent change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: Baseline, 48 Weeks ]The ADCS-ADL assesses a subject's ability to perform activities of daily living such as eating, walking and bathing.
- Alzheimer Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC+) [ Time Frame: Baseline, 48 Weeks ]The ADCS-CGIC+ uses structured interviews with the subject and his or her caregiver to determine whether there has been a change in the subject's overall level of functioning.
- Percent change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: Baseline, 48 Weeks ]The RBANS is a set of tests that measures thinking abilities including memory, language and attention.
- Percent change in Burden Inventory [ Time Frame: Baseline, 48 Weeks ]The Burden Inventory is a questionnaire that assesses how people sometimes feel when they are taking care of another person.
- Percent change in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, 48 Weeks ]The NPI measures behavioral and emotional symptoms of Alzheimer's Disease.
- Change in Brain Magnetic Resonance Imaging (MRI) biomarkers [ Time Frame: Baseline, 48 Weeks ]Percent change in volume of AD-related brain regions (hippocampi, ventricles) and hippocampal perfusion measured with Arterial Spin Labeling (ASL) will be assessed.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 65 Years to 120 Years (Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Female, post-menopausal
- Probable AD or MCI due to AD according to NIA-AA criteria
- Taking a stable dose of donepezil (Aricept) for at least 90 days prior to baseline, and dosage likely to remain stable throughout the trial
- not taking memantine (Namenda)
- MOCA > 11 or blind MOCA > 8 (inclusive) at screening visit
- Hachinski score <5 supporting clinical judgment that dementia is not of vascular origin
- Fluent in English
- 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 Scale > 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

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
Contact: Sarah Khan | 830-582-4632 | skh4002@med.cornell.edu | |
Contact: Tom Maloney, PhD | 646-962-8502 | trm4001@med.cornell.edu |
United States, Florida | |
University of Miami Miller School of Medicine | Not yet recruiting |
Palm Beach Gardens, Florida, United States, 33410 | |
Contact: Susan Rawn, RN sxr3381@med.miami.edu | |
Principal Investigator: James E Galvin, MD | |
United States, New York | |
Weill Medical College of Cornell University | Recruiting |
New York, New York, United States, 10021 | |
Contact: Sarah Khan 830-582-4632 skh4002@med.cornell.edu | |
Contact: Patrick Harvey, MA 830-582-4632 pah2018@med.cornell.edu | |
Principal Investigator: Tracy A Butler, MD | |
United States, Wisconsin | |
University of Wisconsin - Madison | Not yet recruiting |
Madison, Wisconsin, United States, 53792 | |
Contact: Rebecca Kintner 608-262-3456 rkintner@clinicaltrials.wisc.edu | |
Principal Investigator: Craig S Atwood, PhD |
Principal Investigator: | Tracy A Butler, MD | Weill Medical College of Cornell University | |
Principal Investigator: | James E Galvin, MD | University of Miami | |
Principal Investigator: | Craig S Atwood, PhD | University of Wisconsin, Madison |
Documents provided by Weill Medical College of Cornell University:
Responsible Party: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT03649724 |
Other Study ID Numbers: |
19-05020209 R01AG057681-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | August 28, 2018 Key Record Dates |
Last Update Posted: | August 2, 2021 |
Last Verified: | July 2021 |
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: | Research data and results that document and support the study aims will be available after the final results are accepted for publication. |
Access Criteria: | Approval from PI |
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 |
Alzheimer Disease Cognitive Dysfunction Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders |
Mental Disorders Cognition Disorders Leuprolide Fertility Agents, Female Fertility Agents Reproductive Control Agents Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |