A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants With Early Cognitive Decline, at Least One Core Clinical Feature of Dementia With Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-pathology
Status: Recruiting
Location: See all (72) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 85
Healthy Volunteers: f
View:
• Have gradual and progressive cognitive decline for greater than or equal to ( ≥) 6 months.
• Have least 1 core clinical feature of dementia with Lewy bodies (DLB).
• Have a score ≥20 on Montreal Cognitive Assessment (MoCA).
• Meet plasma P-tau217 criteria.
• Have a cerebrospinal fluid (CSF) result consistent with the presence of brain amyloid pathology.
• Have a CSF result consistent with the presence of alpha-synuclein pathology.
• Have at least 1 reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant, and is familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
Locations
United States
Arizona
TrialSphere Corp
RECRUITING
Chandler
HonorHealth Research Institute
NOT_YET_RECRUITING
Scottsdale
California
Profound Research LLC
NOT_YET_RECRUITING
Carlsbad
Irvine Clinical Research
NOT_YET_RECRUITING
Irvine
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
NOT_YET_RECRUITING
La Jolla
Stanford Neuroscience Health Center
NOT_YET_RECRUITING
Palo Alto
Colorado
CenExel Rocky Mountain Clinical Research
NOT_YET_RECRUITING
Englewood
Connecticut
Ki Health Partners, LLc, dba New England Institute for Clinical Research
NOT_YET_RECRUITING
Stamford
Florida
JEM Research Institute
RECRUITING
Atlantis
VIN - Aventura
NOT_YET_RECRUITING
Aventura
Brain Matters Research
RECRUITING
Delray Beach
Neuropsychiatric Research Center of Southwest Florida
NOT_YET_RECRUITING
Fort Myers
Norman Fixel Institute for Neurological Diseases (FIND)
NOT_YET_RECRUITING
Gainesville
Mayo Clinic in Florida
NOT_YET_RECRUITING
Jacksonville
K2 Medical Research ORLANDO
RECRUITING
Maitland
BRP-Kendal Lakes
NOT_YET_RECRUITING
Miami
Renstar Medical Research
RECRUITING
Ocala
Charter Research - Orlando
RECRUITING
Orlando
Axiom Brain Health LLC
NOT_YET_RECRUITING
Tampa
Palm Beach Neurology
RECRUITING
West Palm Beach
Conquest Research
RECRUITING
Winter Park
Indiana
Indiana University Health Neuroscience Center
NOT_YET_RECRUITING
Indianapolis
Kansas
The University of Kansas - Clinical Research Center
NOT_YET_RECRUITING
Fairway
Massachusetts
Massachusetts General Hospital - Charlestown
NOT_YET_RECRUITING
Charlestown
K2 Medical Research - Foxborough
NOT_YET_RECRUITING
Foxborough
Neurology Center of New England
NOT_YET_RECRUITING
Foxborough
Headlands Eastern MA LLC
NOT_YET_RECRUITING
Plymouth
Michigan
QUEST Research Institute
NOT_YET_RECRUITING
Farmington Hills
Minnesota
Struthers Parkinson's Center
NOT_YET_RECRUITING
Golden Valley
Mayo Clinic in Rochester, Minnesota
NOT_YET_RECRUITING
Rochester
Missouri
Citizens Memorial Hospital District
RECRUITING
Bolivar
Oregon
Oregon Health and Science University
NOT_YET_RECRUITING
Portland
Summit Headlands
NOT_YET_RECRUITING
Portland
Pennsylvania
Pennsylvania Hospital
NOT_YET_RECRUITING
Philadelphia
Texas
Gadolin Research
NOT_YET_RECRUITING
Beaumont
Kerwin Medical Center
NOT_YET_RECRUITING
Dallas
Houston Methodist Hospital
NOT_YET_RECRUITING
Houston
The University of Texas Health Science Center at Houston
NOT_YET_RECRUITING
Houston
Central Texas Neurology Consultants
NOT_YET_RECRUITING
Round Rock
The University of Texas Health Science Center
NOT_YET_RECRUITING
San Antonio
Virginia
Re:Cognition Health
NOT_YET_RECRUITING
Fairfax
Washington
EvergreenHealth
NOT_YET_RECRUITING
Kirkland
Other Locations
Japan
Memory Clinic Ochanomizu
NOT_YET_RECRUITING
Bunkyō City
Shonan Keiiku Hospital
NOT_YET_RECRUITING
Fujisawa
Hyogo Prefectural Harima-Himeji General Medical Center
NOT_YET_RECRUITING
Himeji
Inage Neurology and Memory Clinic
NOT_YET_RECRUITING
Inage
Nippon Medical School Musashi Kosugi Hospital
NOT_YET_RECRUITING
Kawasaki
St. Marianna University Hospital
NOT_YET_RECRUITING
Kawasaki
Kobe University Hospital
NOT_YET_RECRUITING
Kobe
Juntendo Tokyo Koto Geriatric Medical Center
NOT_YET_RECRUITING
Kōtoku
Katayama Medical Clinic
NOT_YET_RECRUITING
Kurashiki
Nagoya Ekisaikai Hospital
NOT_YET_RECRUITING
Nagoya
Nagoya University Hospital
NOT_YET_RECRUITING
Nagoya
National Center for Geriatrics and Gerontology
NOT_YET_RECRUITING
Ōbu
The University of Osaka Hospital
NOT_YET_RECRUITING
Suita
Tokyo Metropolitan Institute for Geriatrics and Gerontology
NOT_YET_RECRUITING
Tabashi City
Tachikawa Hospital
NOT_YET_RECRUITING
Tachikawa
Memory Clinic Toride
NOT_YET_RECRUITING
Toride
Yokohama Minami Kyosai Hospital
NOT_YET_RECRUITING
Yokohama
Oita University Hospital
NOT_YET_RECRUITING
Yufu
Republic of Korea
Gangnam Severance Hospital, Yonsei University Health System
NOT_YET_RECRUITING
Gangnam-gu
Inha University Hospital
NOT_YET_RECRUITING
Incheon
Ewha Womans University Mokdong Hospital
NOT_YET_RECRUITING
Seoul
Hanyang University Seoul Hospital
NOT_YET_RECRUITING
Seoul
Konkuk University Medical Center
NOT_YET_RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
NOT_YET_RECRUITING
Seoul
Taiwan
New Taipei Municipal TuCheng Hospital
NOT_YET_RECRUITING
New Taipei City
Taipei Medical University Shuang Ho Hospital
NOT_YET_RECRUITING
New Taipei City
National Cheng Kung University Hospital
NOT_YET_RECRUITING
Tainan
National Taiwan University Hospital
NOT_YET_RECRUITING
Taipei
Taipei Veterans General Hospital
NOT_YET_RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
NOT_YET_RECRUITING
Taoyuan
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2026-05-20
Estimated Completion Date: 2028-08
Participants
Target number of participants: 350
Treatments
Experimental: Donanemab (LY3002813)
Donanemab (LY3002813) administered as an intravenous (IV) infusion
Placebo_comparator: Placebo
Placebo administered IV
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company