A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease
- Registration Number
- NCT05063539
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this study is to assess the safety, tolerability and effect of study drug LY3372689 in participants with early symptomatic Alzheimer's Disease
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 330
- Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months
- MMSE score of 22 to 30 (inclusive) at baseline
- CDR global score of 0.5 to 1.0 (inclusive), with a memory box score ≥0.5.
- Meet 18F flortaucipir positron emission tomography (PET) scan (central analysis) criteria
- Have a study partner who will provide written informed consent to participate
- Contraindication to MRI or PET scans
- Have known allergies to LY3372689, related compounds, or any components of the formulations
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo given orally LY3372689 Low Dose LY3372689 LY3372689 given orally LY3372689 High Dose LY3372689 LY3372689 given orally
- Primary Outcome Measures
Name Time Method Change from Baseline to End Time Point in Integrated Alzheimer's Disease Rating Scale (iADRS) Baseline, 76 to 124 Weeks Change from Baseline to End Time Point in iADRS will be measured in participants with early symptomatic Alzheimer's Disease (AD) with demonstrated presence of moderate levels of tau pathology
- Secondary Outcome Measures
Name Time Method Change From Baseline to End Time Point in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Baseline, 76 to 124 Weeks Change From Baseline to End Time Point in CDR-SB
Change from Baseline to End Time Point in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Baseline, 76 to 124 Weeks Change from Baseline to End Time Point in ADAS-Cog13
Change from Baseline to End Time Point in Alzheimer's Disease Cooperative Study Instrumental Activities of Daily Living Inventory (ADCS-iADL) Baseline, 76 to 124 Weeks Change from Baseline to End Time Point in ADCS-iADL
Pharmacokinetics (PK) Plasma Concentration of LY3372689 Up to 124 Weeks PK Plasma Concentration of LY3372689
Change from Baseline to End Time Point in iADRS Baseline, 76 to 124 Weeks Change from baseline to end point time in iADRS will be measured in the full study population (moderate + high levels of tau pathology) with early symptomatic AD
Change from Baseline to End Time Point in Brain Tau Deposition as Measured by Flortaucipir F18 PET scan Baseline, 76 to 124 Weeks Change from Baseline to End Time Point in Brain Tau Deposition as Measured by Flortaucipir F18 PET scan
Change from Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures Baseline, 76 to 124 Weeks Change from Baseline to End Time Point in Volumetric MRI Measures
Change from Baseline to End Time Point in Mini Mental State Examination (MMSE) Baseline, 76 to 124 Weeks Change from Baseline to End Time Point in MMSE
Trial Locations
- Locations (68)
Memory Clinic Toride
🇯🇵Toride, Ibaraki, Japan
St Vincent's Hospital
🇦🇺Sydney, New South Wales, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Hope Clinical Research, Inc.
🇺🇸Canoga Park, California, United States
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
Irvine Clinical Research
🇺🇸Irvine, California, United States
Sharp Mesa Vista Hospital
🇺🇸San Diego, California, United States
Institute for Neurodegenerative Disorders
🇺🇸New Haven, Connecticut, United States
JEM Research Institute
🇺🇸Atlantis, Florida, United States
VIN-Julie Schwartzbard
🇺🇸Aventura, Florida, United States
Neurology Offices of South Florida
🇺🇸Boca Raton, Florida, United States
Brain Matters Research
🇺🇸Stuart, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
🇺🇸Fort Myers, Florida, United States
K2 Medical Research
🇺🇸Maitland, Florida, United States
ClinCloud - Viera
🇺🇸Melbourne, Florida, United States
Merritt Island Medical Research, LLC
🇺🇸Merritt Island, Florida, United States
VIN-Andrew Lerman
🇺🇸Miami, Florida, United States
IMIC, Inc.
🇺🇸Miami, Florida, United States
VIN-Victor Faradji
🇺🇸Miami, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
VIN- Margarita Almeida El-Ramey
🇺🇸Pembroke Pines, Florida, United States
Charter Research - Lady Lake
🇺🇸The Villages, Florida, United States
Josephson Wallack Munshower Neurology, PC
🇺🇸Indianapolis, Indiana, United States
Boston Center for Memory
🇺🇸Newton, Massachusetts, United States
Donald S. Marks M.D., P.C.
🇺🇸Plymouth, Massachusetts, United States
MedVadis Research Corporation
🇺🇸Waltham, Massachusetts, United States
The Cognitive and Research Center of New Jersey
🇺🇸Springfield, New Jersey, United States
Adams Clinical
🇺🇸Watertown, Massachusetts, United States
Advanced Memory Research Institute of New Jersey
🇺🇸Toms River, New Jersey, United States
University at Buffalo - UBMD Neurology
🇺🇸Buffalo, New York, United States
Abington Neurological Associates, Ltd.
🇺🇸Abington, Pennsylvania, United States
Keystone Clinical Studies
🇺🇸Plymouth Meeting, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
Kerwin Medical Center
🇺🇸Dallas, Texas, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
The Memory Clinic
🇺🇸Bennington, Vermont, United States
Central Coast Neurosciences Research (Tumbi Umbi)
🇦🇺Central Coast, New South Wales, Australia
HammondCare Greenwich Hospital
🇦🇺Sydney, New South Wales, Australia
Hornsby Ku-Ring-Gai Hospital
🇦🇺Sydney, New South Wales, Australia
KARA Institute for Neurological Diseases
🇦🇺Sydney, New South Wales, Australia
Private Practice - Dr PL Morris
🇦🇺Southport, Queensland, Australia
The Queen Elizabeth Hospital
🇦🇺Woodville, South Australia, Australia
NeuroCentrix
🇦🇺Carlton, Victoria, Australia
Delmont Private Hospital
🇦🇺Glen Iris, Victoria, Australia
HammondCare
🇦🇺Malvern, Victoria, Australia
Bruyère Research Institute
🇨🇦Ottawa, Ontario, Canada
Clinique de la Mémoire de l'Outaouais
🇨🇦Ottawa, Ontario, Canada
Ottawa Memory Clinic
🇨🇦Ottawa, Ontario, Canada
Toronto Memory Program
🇨🇦Toronto, Ontario, Canada
Diex Recherche Sherbrooke Inc.
🇨🇦Sherbrooke, Quebec, Canada
National Center for Geriatrics and Gerontology
🇯🇵Obu City, Aichi, Japan
Himeji Central Hospital Affiliated Clinic
🇯🇵Himeji, Hyogo, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe, Hyogo, Japan
Oita University Hospital
🇯🇵Yufu, Oita, Japan
Katayama Medical Clinic
🇯🇵Kurashiki, Okayama, Japan
Nozomi Memory Clinic
🇯🇵Mitaka-shi, Tokyo, Japan
Kikukawa Clinic
🇯🇵Nerima, Tokyo, Japan
Memory Clinic Ochanomizu
🇯🇵Tokyo, Japan
Wroclawskie Centrum Alzheimerowskie
🇵🇱Wroclaw, Dolnośląskie, Poland
Centrum Medyczne NEUROMED
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Centrum Medyczne NeuroProtect
🇵🇱Warszawa, Mazowieckie, Poland
Diamond Clinic
🇵🇱Krakow, Małopolskie, Poland
Podlaskie Centrum Psychogeriatrii
🇵🇱Białystok, Podlaskie, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
🇵🇱Gdansk, Pomorskie, Poland
Centrum Medyczne SENIOR
🇵🇱Sopot, Pomorskie, Poland
Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
🇵🇱Poznan, Wielkopolskie, Poland
Centrum Medyczne Euromedis
🇵🇱Szczecin, Zachodniopomorskie, Poland