CompletedPhase 2

A Study of Mevidalen (LY3154207) in Participants With Alzheimer's Disease

A Randomized, Double-Blinded Study to Evaluate the Efficacy and Safety of Mevidalen in Patients With Alzheimer's Disease

Lead sponsor

Eli Lilly and Company

Asset

Mevidalen

Listed sites

Recruiting sites

Enrollment

304

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Tau biomarker required (plasma)•MMSE 13-24•Study partner/caregiver required

Primary endpoint

•Integrated Alzheimer's Disease Rating Scale (iADRS)

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 ID18822

Secondary IDI7S-MC-HBEOEli Lilly and Company

NCT IDNCT06538116

Timeline

Milestones

Study first posted2024-08-05actual

Study start2024-08-26actual

Primary completion2026-05-01actual

Study completion2026-05-11actual

Last update posted2026-06-18actual

Assets

Drug assets

Mevidalen

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have gradual and progressive decline in memory function for greater than or equal to 6 months that is severe enough to interfere with activities of daily living.

•Have MMSE score of 13 to 24.

•Have eligibile plasma P-tau or historical evidence of AD pathology.

•Have a reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant and will be available at designated times.

•Males with partners of childbearing potential must agree to abide with provided contraception guidance

Exclusion criteria

•Are individuals of childbearing potential.

•Have significant central nervous system or psychiatric disease, other than AD, that in the investigator's opinion may affect cognition or the ability to complete the study (e.g: head trauma, stroke, seizure disorder etc.,).

•Have cardiovascular-related risk factors or history that include uncontrolled hypertension, heart failure, stroke; or liver-related abnormalities.

•Use of moderate or strong CYP3A4 inhibitors or inducers.

•Have participated within the last 30 days in a clinical trial involving an investigational product.

•Participant is, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.

Endpoints (11)

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

Executive function / language

Behavior / neuropsychiatric

Other (unclassified)

Memory

Function / daily living

Other clinical outcomes

Global cognition

2 endpoints

Secondary/protocol endpoint

Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13)

Time frame:Baseline, Week 24

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Mini Mental State Examination (MMSE)

Time frame:Baseline, Week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Memory

1 endpoint

Secondary/protocol endpoint

Change from Baseline in Category Fluency Test

Time frame:Baseline, Week 24

change from baseline, improvement

Executive function / language

2 endpoints

Secondary/protocol endpoint

Change from Baseline in Verbal Fluency Test

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Digit Symbol Coding Test( Wechsler Adult Intelligence Scale-IV)(WAIS-IV)

Time frame:Baseline, Week 24

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

Change from Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)

Time frame:Baseline, Week 24

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Change from Baseline on Neuropsychiatric Inventory (NPI-12)

Time frame:Baseline, Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline on Quick Dementia Rating Scale (QDRS)

Time frame:Baseline, Week 24

change from baseline, improvement

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change score (ADCS-CGIC)

Time frame:Week 24

change from baseline, improvement

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS)

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline on Epworth Sleepiness Scale (ESS)

Time frame:Baseline, Week 24

change from baseline, improvement

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.