Clinical trial NCT06538116: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Alzheimer Disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-08-05
Enrollment: 300
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS)
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13)
timeFrame: Baseline, Week 24
measure: Change from Baseline in Verbal Fluency Test
timeFrame: Baseline, Week 24
measure: Change from Baseline in Category Fluency Test
timeFrame: Baseline, Week 24
measure: Change from Baseline in Digit Symbol Coding Test( Wechsler Adult Intelligence Scale-IV)(WAIS-IV)
timeFrame: Baseline, Week 24
measure: Change from Baseline in Mini Mental State Examination (MMSE)
timeFrame: Baseline, Week 24
measure: Change from Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
timeFrame: Baseline, Week 24
measure: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change score (ADCS-CGIC)
timeFrame: Week 24
measure: Change from Baseline on Neuropsychiatric Inventory (NPI-12)
timeFrame: Baseline, Week 24
measure: Change from Baseline on Epworth Sleepiness Scale (ESS)
timeFrame: Baseline, Week 24
measure: Change from Baseline on Quick Dementia Rating Scale (QDRS)
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Carlsbad
country: United States
facility: Profound Research, LLC
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, Inc.
state: California
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Aventura
country: United States
facility: Visionary Investigators Network
state: Florida
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials
state: Florida
city: Clermont
country: United States
facility: Vertex Clinical Research
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of Southwest Florida
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Merritt Island
country: United States
facility: Merritt Island Medical Research, LLC
state: Florida
city: Miami
country: United States
facility: Visionary Investigators Network
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Charter Research
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Sarasota
country: United States
facility: Intercoastal Medical Group - Hyde Park
state: Florida
city: Stuart
country: United States
facility: Brain Matters Research
state: Florida
city: The Villages
country: United States
facility: Charter Research, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute at Palm Beach Neurology
state: Florida
city: Winter Park
country: United States
facility: Conquest Clinical Research, LLC
state: Florida
city: Decatur
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Decatur
country: United States
facility: NeuroStudies
state: Georgia
city: Savannah
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience
state: Hawaii
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology, PC
state: Indiana
city: Methuen
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Farmington Hills
country: United States
facility: QUEST Research Institute
state: Michigan
city: Lincoln
country: United States
facility: Be Well Clinical Studies
state: Nebraska
city: Toms River
country: United States
facility: CenExel Advanced Memory Research Institute of NJ
state: New Jersey
city: Matthews
country: United States
facility: AMC Research
state: North Carolina
city: Raleigh
country: United States
facility: Eximia Research-NC, LLC
state: North Carolina
city: Plymouth Meeting
country: United States
facility: Keystone Clinical Studies
state: Pennsylvania
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions Inc
state: Tennessee
city: Arlington
country: United States
facility: Cedar Health Research LLC
state: Texas
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: Dallas
country: United States
facility: Kerwin Medical Center
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Rio Grande City
country: United States
facility: El Faro Health and Therapeutics
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Seattle
country: United States
facility: University of Washington - Harborview Medical Center
state: Washington
city: Obu
country: Japan
facility: National Center for Geriatrics and Gerontology
state: Aichi
city: Matsudo-shi
country: Japan
facility: Mabashi Clinic
state: Chiba-Ken
city: Inage
country: Japan
facility: Inage Neurology and Memory Clinic
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Mental Clinic Sakurazaka
state: Fukuoka-Ken
city: Fukuoka-shi
country: Japan
facility: Kuramitsu Hospital
state: Fukuoka-ken
city: Koriyama-shi
country: Japan
facility: Southern TOHOKU Medical Clinic
state: Fukushima-Ken
city: Fujioka-shi
country: Japan
facility: Ikuseikai Shinozuka Hospital
state: Gunma-Ken
city: Kiryu-shi
country: Japan
facility: Medical Corporation Kishikai Kishi Hospital
state: Gunma-Ken
city: Hiroshima-shi
country: Japan
facility: Cocoro Hospital Kusatsu
state: Hiroshima-Ken
city: Himeji
country: Japan
facility: Himeji Central Hospital Affiliated Clinic
state: Hyogo
city: Toride
country: Japan
facility: Memory Clinic Toride
state: Ibaraki
city: Yufu
country: Japan
facility: Oita University Hospital
state: Oita
city: Kurashiki
country: Japan
facility: Katayama Medical Clinic
state: Okayama
city: Kanzaki-gun
country: Japan
facility: NHO Hizen Psychiatric Center
state: Saga-Ken
city: Karatsu-shi
country: Japan
facility: Rainbow & Sea Hospital
state: Saga-Ken
city: Bunkyo-ku
country: Japan
facility: Memory Clinic Ochanomizu
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Akita
country: Japan
facility: Akita City Hospital
city: Sumida-ku
country: Japan
facility: Tokyo Metro Bokutoh Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: