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Alzheimer DiseasePhase 2NCT06538116

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

A Phase 2 study testing Mevidalen in people with Alzheimer Disease, run by Eli Lilly and Company at 64 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of this study is to look at how safe the study drug (mevidalen) is and whether it works to alleviate symptoms when given to people with mild to moderate Alzheimer Disease (AD) dementia. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Mevidalen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
304 participants
Where
64 sitesin 2 countries
Study dates
26 Aug 2024to 11 May 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

64 sites in 2 countries.

64 sites in 2 countries

United States44 sites

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Senior Adults Specialty Research

    Austin, Texas, 78757

  • Visionary Investigators Network

    Aventura, Florida, 33180

  • Excel Medical Clinical Trials, LLC Boca Raton dba Flourish Research

    Boca Raton, Florida, 33434

  • Profound Research LLC At The Neurology Center of Southern California

    Carlsbad, California, 92011

  • Vertex Clinical Research

    Clermont, Florida, 34711

  • Kerwin Medical Center

    Dallas, Texas, 75231

  • Accel Research Sites - NeuroStudies CRU

    Decatur, Georgia, 30030

  • CenExel iResearch Atlanta

    Decatur, Georgia, 30030

  • Ascension Alexian Brothers

    Elk Grove Village, Illinois, 60007

  • Cedar Health Research, LLC

    Euless, Texas, 76040

  • QUEST Research Institute

    Farmington Hills, Michigan, 48334

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Neuropain Medical Center

    Fresno, California, 93710

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817

  • Clinical Trial Network LLC

    Houston, Texas, 77074

  • Josephson, Wallack, Munshower Neurology, P.C.

    Indianapolis, Indiana, 46256

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256

  • Baptist Health Center for Clinical Research LLC

    Little Rock, Arkansas, 72205

  • AMC Research, LLC dba Flourish Research

    Matthews, North Carolina, 28105

  • Clinical Neuroscience Solutions, Inc.Ta

    Memphis, Tennessee, 38119

  • Merritt Island Medical Research, LLC dba Flourish Research

    Merritt Island, Florida, 32952

  • ActivMed Practices & Research, LLC

    Methuen, Massachusetts, 01844

  • Visionary Investigators Network

    Miami, Florida, 33176

  • Catalina Research Institute

    Montclair, California, 91763

  • Suncoast Clinical Research - New Port Richey

    New Port Richey, Florida, 34652

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Charter Research, LLC

    Orlando, Florida, 32803

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • Keystone Clinical Studies, LLC Philadelphia dba Flourish Research

    Plymouth Meeting, Pennsylvania, 19462

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Eximia Clinical Research-NC, LLC

    Raleigh, North Carolina, 27612

  • El Faro Health and Therapeutics

    Rio Grande City, Texas, 78582

  • Be Well Clinical Studies

    Round Rock, Texas, 78681

  • Clinical Trials of Texas, LLC San Antonio dba Flourish Research

    San Antonio, Texas, 78229

  • Intercoastal Medical Group

    Sarasota, Florida, 34239

  • CenExel iResearch, LLC

    Savannah, Georgia, 31405

  • University of Washington Medical Center

    Seattle, Washington, 98104

  • California Neuroscience Research, LLC

    Sherman Oaks, California, 91403

  • Brain Matters Research

    Stuart, Florida, 34997

  • Charter Research - The Villages

    The Villages, Florida, 32162

  • CenExel Advanced Memory Research Institute of NJ

    Toms River, New Jersey, 08755

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida, 33407

  • Conquest Research

    Winter Park, Florida, 32789

Other trials in United States

Japan20 sites

  • Akita City Hospital

    Akita, 010-0933

  • Memory Clinic Ochanomizu

    Bunkyō City, 113-0034

  • Inage Neurology and Memory Clinic

    Chiba, 263-0043

  • Ikuseikai Shinozuka Hospital

    Fujioka-shi, 375-0017

  • Mental Clinic Sakurazaka

    Fukuoka, 810-0023

  • Kuramitsu Hospital

    Fukuoka, 819-0037

  • Himeji Central Hospital Clinic

    Himeji-shi, 672-8043

  • Koseikai Cocoro Hospital Kusatsu

    Hiroshima, 733-0864

  • NHO Hizen Psychiatric Medical Center

    Kanzaki-gun, 842-0192

  • Rainbow & Sea Hospital

    Karatsu-shi, 847-0031

  • Kishikai Kishi Hospital

    Kiryu-shi, 376-0011

  • Southern TOHOKU Medical Clinic

    Koriyama-shi, 963-8563

  • Katayama Medical Clinic

    Kurashiki-shi, 710-0813

  • Mabashi Clinic

    Matsudo-shi, 271-0047

  • National Center for Geriatrics and Gerontology

    Obu-shi, 474-8511

  • Tokyo Medical University Hospital

    Shinjuku-ku, 160-0023

  • Tokyo Metropolitan Bokutoh Hospital

    Sumida-ku, 130-8575

  • Memory Clinic Toride

    Toride-shi, 302-0004

  • Yamagata University Hospital

    Yamagata, 990-9585

  • Oita University Hospital

    Yufu-shi, 879-5593

Other trials in Japan

About this study

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

The main purpose of this study is to look at how safe the study drug (mevidalen) is and whether it works to alleviate symptoms when given to people with mild to moderate Alzheimer Disease (AD) dementia. This is done by looking at participants: thinking and memory (cognition), everyday activities and sleep, AD symptoms, physical activity, irritability or anxiety. The study is expected to last approximately 26 weeks and may include up to 14 visits.

Being tested
Mevidalen, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MevidalenDrug

    Also called LY3154207

    Administered orally

  • PlaceboDrug

    Administered orally

Study groups in NCT06538116
Study groupRoleWhat they receive
Mevidalen (high dose)ExperimentalMevidalen high dose administered orally.
Receives: Drug: Mevidalen
Mevidalen (low dose)ExperimentalMevidalen low dose administered orally.
Receives: Drug: Mevidalen
PlaceboPlacebo comparatorPlacebo administered orally.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    iADRS assesses the impact of cognitive loss on everyday activities and provides a measure of global AD severity as a single summary score. It comprises of 2 underlying domains "cognitive ability" and "functional ability," and integrates the items in both the domains a single overall score ranging from 0 to 144, with lower scores indicating worse performance.

    Measured: Baseline, Week 24

Secondary outcomes (10)

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

    The ADAS-Cog13 consists of 13 items which assess the areas of cognitive function that are the most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, and digit cancellation measures. The scale ranges from 0 to 85, with higher scores indicating greater disease severity.

    Measured: Baseline, Week 24

  2. Change from Baseline in Verbal Fluency Test

    The Verbal Fluency Test, also known as the FAS test, requires participants to say as many words as possible beginning with specific letters (F, A, and S) in 1 minute. The FAS score corresponds to the number of words generated by each participant under each letter category within 1 minute. A higher score indicates better performance.

    Measured: Baseline, Week 24

  3. Change from Baseline in Category Fluency Test

    The Category Fluency test is a measure of semantic memory and involves planning, organization, and cognitive flexibility. The participant is asked to generate as many words as possible in 1 minute that belong to the animal semantic category. Total score is the sum of correct words generated for the animal category, and higher values indicate better performance.

    Measured: Baseline, Week 24

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

    The Digit Symbol-Coding test from the WAIS-IV involves testing processing speed among subjects; The digit symbol coding requires a subject to match symbols to numbers according to a key. The number of correct symbols within the allowed time constitutes the score, and higher values indicate better performance.

    Measured: Baseline, Week 24

  5. Change from Baseline in Mini Mental State Examination (MMSE)

    The MMSE is a brief instrument used to assess global cognition. The instrument measures orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures. Total score ranges from 0 to 30, with lower score indicating greater level of impairment.

    Measured: Baseline, Week 24

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

    The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire that is to be answered by the participant's study partner. Study partner is asked to observe and rate the performance of activities of daily living attempted by participants. The range for the total ADCS-ADL score is 0 to 78, with lower scores indicating greater level of impairment.

    Measured: Baseline, Week 24

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

    The ADCS-CGIC is a 7-point, categorical scale that provides a single global rating of change from baseline. A score of 1 indicates marked improvement; a score of 2, moderate improvement; a score of 3, minimal improvement; a score of 4, no change; a score of 5, minimal worsening; a score of 6, moderate worsening; and a score of 7, marked worsening.

    Measured: Week 24

  8. Change from Baseline on Neuropsychiatric Inventory (NPI-12)

    The NPI-12 is rating instrument to assess abnormal behaviors in dementia patients by informant-based interview that utilizes scripted questions to explore 12 different symptom domains: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, aberrant motor activity, night-time behavioral disturbances, and appetite and eating abnormalities. The frequency of behaviour is scored from 0 (Rarely) to 4 (very often) and the severity from 0 (mild) to 3 (severe). A total score for each symptom is calculated by multiplying the frequency rating by the severity rating. The total NPI-12 score is the sum of all symptom scores and ranges from 0 to 144, with higher scores indicating a greater degree of symptomatology.

    Measured: Baseline, Week 24

  9. Change from Baseline on Epworth Sleepiness Scale (ESS)

    ESS is an 8-item questionnaire that measures the chances of "dozing off" in different daytime situations over the past week. Scores range from 0 to 24, with scores greater than or equal to 10 indicating excessive daytime sleepiness.

    Measured: Baseline, Week 24

  10. Change from Baseline on Quick Dementia Rating Scale (QDRS)

    The QDRS is a 10-item rating scale that assesses aspects of cognition, behavior, and daily functioning on a 5-point scale where no problems = 0, slight problems = 0.5, mild problems = 1, moderate to severe problems = 2, and severe problems = 3. Total scores range from 0 to 30 and higher scores indicate increased cognitive impairment.

    Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2024
  2. Study start26 Aug 2024
  3. Primary completion1 May 2026
  4. Study completion11 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
304 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06538116
Sponsor's protocol ID
18822
Other IDs
I7S-MC-HBEO
Status last verified
Jun 2026
First submitted
1 Aug 2024
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mevidalen in people with Alzheimer Disease, run by Eli Lilly and Company at 64 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06538116.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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