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

Phase
Recruitment status
Participants
Lead sponsor
Eli Lilly and Company
Start date
Number of sites

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. 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.
Short title
A Study of Mevidalen (LY3154207) in Participants With Alzheimer's Disease
Official title
A Randomized, Double-Blinded Study to Evaluate the Efficacy and Safety of Mevidalen in Patients With Alzheimer's Disease

Control arm
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Actual participants
Participants
Participant count basis
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Eli Lilly and Company
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design

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

    Timeframe: Baseline, Week 24

    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.

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

    Timeframe: Baseline, Week 24

    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.

  2. Change from Baseline in Verbal Fluency Test

    Timeframe: Baseline, Week 24

    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.

  3. Change from Baseline in Category Fluency Test

    Timeframe: Baseline, Week 24

    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.

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

    Timeframe: Baseline, Week 24

    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.

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

    Timeframe: Baseline, Week 24

    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.

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

    Timeframe: Baseline, Week 24

    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.

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

    Timeframe: Week 24

    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.

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

    Timeframe: Baseline, Week 24

    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.

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

    Timeframe: Baseline, Week 24

    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.

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

    Timeframe: Baseline, Week 24

    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.

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
50 Years
Maximum age
80 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility

  • Banner Alzheimer's InstitutePhoenix, United States
  • Baptist Health Center for Clinical Research LLCLittle Rock, United States
  • Profound Research LLC At The Neurology Center of Southern CaliforniaCarlsbad, United States
  • Neuropain Medical CenterFresno, United States
  • Catalina Research InstituteMontclair, United States
  • California Neuroscience Research, LLCSherman Oaks, United States
  • JEM Research InstituteAtlantis, United States
  • Visionary Investigators NetworkAventura, United States
  • Excel Medical Clinical Trials, LLC Boca Raton dba Flourish ResearchBoca Raton, United States
  • Vertex Clinical ResearchClermont, United States
  • Neuropsychiatric Research Center of Southwest FloridaFort Myers, United States
  • Clinical Neuroscience Solutions, Inc.Jacksonville, United States
  • Merritt Island Medical Research, LLC dba Flourish ResearchMerritt Island, United States
  • Visionary Investigators NetworkMiami, United States
  • Suncoast Clinical Research - New Port RicheyNew Port Richey, United States
  • Renstar Medical ResearchOcala, United States
  • Charter Research, LLCOrlando, United States
  • Progressive Medical ResearchPort Orange, United States
  • Intercoastal Medical GroupSarasota, United States
  • Brain Matters ResearchStuart, United States
  • Charter Research - The VillagesThe Villages, United States
  • Premiere Research Institute at Palm Beach NeurologyWest Palm Beach, United States
  • Conquest ResearchWinter Park, United States
  • Accel Research Sites - NeuroStudies CRUDecatur, United States
  • CenExel iResearch AtlantaDecatur, United States

And 39 more, listed on the interactive page.

Sources for sites

Other registry identifiers

  • I7S-MC-HBEO
Sources for references

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)