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NCT03649724·Phase 2·INTERVENTIONAL

The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's

LeuprolideBrain healthActive, not recruiting

Status

Active, not recruiting

Phase

Phase 2

Enrollment

180

Locations

3

Results

Not posted

Publications

4

Study summary

What the protocol is testing.

The LUCINDA Trial is a three-site, phase II, randomized, double-blind, placebo-controlled study of leuprolide acetate (Eligard) in women with Mild Cognitive Impairment or Alzheimer's Disease taking a stable dose of a cholinesterase inhibitor medication like donepezil. Its objective is to assess the efficacy of a 48-week regimen of leuprolide (22.5 mg per 12 weeks) compared to placebo on cognitive function, global function and plasma and neuroimaging biomarkers.

Full detailed description

This project aims to re-purpose the safe and well-tolerated gonadotropin-releasing hormone (GnRH) analogue Leuprolide Acetate for use in Alzheimer's Disease (AD). Leuprolide Acetate is currently used in adults for prostate cancer, endometriosis, uterine fibroids and in preparation for in-vitro fertilization, and in children for central precocious puberty. The purpose of this study to confirm and extend results from a prior phase II study (Bowen et al, 2015) which demonstrated that Leuprolide halted cognitive and functional decline in a subgroup of women with mild-moderate AD who were also taking the acetylcholinesterase inhibitor donepezil. Objectives are to replicate, in the same subgroup, Leuprolide's clinical EFFICACY in this prior trial and to add neuroimaging and plasma BIOMARKERS that will help elucidate Leuprolide's likely multiple mechanisms of action in AD. These mechanisms include decreasing levels of Luteinizing Hormone (LH) based on extensive preclinical evidence that decreasing LH preserves cognition and decreases amyloid deposition and tau phosphorylation in animal models of AD, as well as new evidence that GnRH analogues may have anti-inflammatory effects.

Interventions

Treatment arms and agents.

DRUG

Placebo

Placebo (0.25 ml normal saline) will be administered subcutaneously once every twelve weeks for 48 weeks.

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.

Timeline

From registration to results.

  1. First posted

    Aug 28, 2018

  2. Study start

    Nov 27, 2020

  3. Primary completion

    Jul 25, 2026

  4. Study completion

    Jul 25, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jun 16, 2026

Outcomes

What the study measures.

Primary outcomes

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.

Secondary outcomes

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.

Eligibility

Who can take part.

Minimum age
60 Years
Maximum age
120 Years
Sex
FEMALE
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 a cholinesterase inhibitor such as donepezil/Aricept and dosage likely to remain stable throughout the trial * 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 * has a study partner / caregiver who interacts with the subject for at least 5 hours per week on average and can 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

Study locations

3 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

University of Miami Miller School of Medicine

Boca Raton, Florida, United States

Weill Medical College of Cornell University

New York, New York, United States

University of Wisconsin - Madison

Madison, Wisconsin, United States

Publications

Results and literature.

PMID 34166841 ↗Butler T, Goldberg JD, Galvin JE, Maloney T, Ravdin L, Glodzik L, de Leon MJ, Hochman T, Bowen RL, Atwood CS. Rationale, study design and implementation of the LUCINDA Trial: Leuprolide plus Cholinesterase Inhibition to reduce Neurologic Decline in Alzheimer's. Contemp Clin Trials. 2021 Aug;107:106488. doi: 10.1016/j.cct.2021.106488. Epub 2021 Jun 22.PMID 35922659 ↗Butler T, Glodzik L, Wang XH, Xi K, Li Y, Pan H, Zhou L, Chiang GC, Morim S, Wickramasuriya N, Tanzi E, Maloney T, Harvey P, Mao X, Razlighi QR, Rusinek H, Shungu DC, de Leon M, Atwood CS, Mozley PD. Positron Emission Tomography reveals age-associated hypothalamic microglial activation in women. Sci Rep. 2022 Aug 3;12(1):13351. doi: 10.1038/s41598-022-17315-8.PMID 35809386 ↗Wickramasuriya N, Hawkins R, Atwood C, Butler T. The roles of GnRH in the human central nervous system. Horm Behav. 2022 Sep;145:105230. doi: 10.1016/j.yhbeh.2022.105230. Epub 2022 Jul 6.PMID 39240636 ↗Butler T, Tey SR, Galvin JE, Perry G, Bowen RL, Atwood CS. Endocrine Dyscrasia in the Etiology and Therapy of Alzheimer's Disease. J Alzheimers Dis. 2024;101(3):705-713. doi: 10.3233/JAD-240334.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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