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LUCINDA

Active not recruitingPhase 2

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

Asset

Leuprolide acetate

Listed sites

3

Recruiting sites

-

Enrollment

180

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•MCI due to AD•MoCA ≥11•Study partner/caregiver required•AD symptomatic therapy: stable•MRI contraindications excluded

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID19-05020209
NCT IDNCT03649724
NihR01AG057681-01A1

Timeline

Milestones

Study first posted2018-08-28actual
Study start2020-11-27actual
Last update posted2026-06-16actual
Primary completion2026-07-25estimated
Study completion2026-07-25estimated

Assets

Drug assets

Leuprolide acetate

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age60 Years
Maximum age120 Years
SexFemale
Healthy volunteersNot accepted

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

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
2
Function / daily living
1
Behavior / neuropsychiatric
1
Neuroimaging
1
Caregiver / quality of life
1
Other (unclassified)
1

Global cognition

2 endpoints
Primary/protocol endpoint

Percent change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog-11)

Time frame:Baseline, 48 Weeks

ADAS-Cog

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Time frame:Baseline, 48 Weeks

percent change from baseline, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

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

ADCS-Activities of Daily Living (ADCS-ADL)

percent change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Percent change in Neuropsychiatric Inventory (NPI)

Time frame:Baseline, 48 Weeks

Neuropsychiatric Inventory (NPI)

percent change from baseline, improvement

Neuroimaging

1 endpoint
Secondary/protocol endpoint

Change in Brain Magnetic Resonance Imaging (MRI) biomarkers

Time frame:Baseline, 48 Weeks

percent change from baseline, improvement

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

Alzheimer Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC+)

Time frame:Baseline, 48 Weeks

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Percent change in Burden Inventory

Time frame:Baseline, 48 Weeks

percent change from baseline, improvement

Publications (4)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.