A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)

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.

Interventions

• Donanemab · DRUG

  Donanemab administered IV

• Placebo · DRUG

  Placebo administered IV

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Have a disease or condition that could interfere with this study or is a current serious or unstable illness.
* Have, or is suspected to have, a significant neurological disease (other than the studied condition) that affects the central nervous system and may affect the individual's cognition or ability to complete the study.
* Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence and preventing the completion of the study.
* Have clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions.
* Have previously received amyloid-targeting therapy.
* Active immunization against amyloid-beta.
* Have a centrally read MRI that does not meet study entry criteria.
* Have contraindication to MRI or PET scans.
* Have any contraindication to lumbar puncture.

Sites (72)

• TrialSphere Corp, Chandler, Arizona · Recruiting
• HonorHealth Research Institute, Scottsdale, Arizona · Not yet recruiting
• Profound Research LLC, Carlsbad, California · Recruiting
• Irvine Clinical Research, Irvine, California · Recruiting
• UCSD - Altman Clinical and Translational Research Institute (ACTRI), La Jolla, California · Not yet recruiting
• Stanford Neuroscience Health Center, Palo Alto, California · Not yet recruiting
• CenExel Rocky Mountain Clinical Research, Englewood, Colorado · Not yet recruiting
• Ki Health Partners, LLc, dba New England Institute for Clinical Research, Stamford, Connecticut · Recruiting
• JEM Research Institute, Atlantis, Florida · Recruiting
• VIN - Aventura, Aventura, Florida · Recruiting
• Brain Matters Research, Delray Beach, Florida · Recruiting
• Neuropsychiatric Research Center of Southwest Florida, Fort Myers, Florida · Recruiting
• Norman Fixel Institute for Neurological Diseases (FIND), Gainesville, Florida · Not yet recruiting
• Mayo Clinic in Florida, Jacksonville, Florida · Not yet recruiting
• K2 Medical Research ORLANDO, Maitland, Florida · Recruiting
• BRP-Kendal Lakes, Miami, Florida · Recruiting
• Renstar Medical Research, Ocala, Florida · Recruiting
• Charter Research - Orlando, Orlando, Florida · Recruiting
• Axiom Brain Health LLC, Tampa, Florida · Recruiting
• Palm Beach Neurology, West Palm Beach, Florida · Recruiting
• Conquest Research, Winter Park, Florida · Recruiting
• Indiana University Health Neuroscience Center, Indianapolis, Indiana · Recruiting
• The University of Kansas - Clinical Research Center, Fairway, Kansas · Not yet recruiting
• Massachusetts General Hospital - Charlestown, Charlestown, Massachusetts · Not yet recruiting
• K2 Medical Research - Foxborough, Foxborough, Massachusetts · Recruiting
• Neurology Center of New England, Foxborough, Massachusetts · Recruiting
• Headlands Eastern MA LLC, Plymouth, Massachusetts · Recruiting
• QUEST Research Institute, Farmington Hills, Michigan · Recruiting
• Struthers Parkinson's Center, Golden Valley, Minnesota · Not yet recruiting
• Mayo Clinic in Rochester, Minnesota, Rochester, Minnesota · Not yet recruiting
• Citizens Memorial Hospital District, Bolivar, Missouri · Recruiting
• Summit Headlands, Portland, Oregon · Recruiting
• Oregon Health and Science University, Portland, Oregon · Not yet recruiting
• Pennsylvania Hospital, Philadelphia, Pennsylvania · Not yet recruiting
• Gadolin Research, Beaumont, Texas · Recruiting
• Kerwin Medical Center, Dallas, Texas · Recruiting
• Houston Methodist Hospital, Houston, Texas · Not yet recruiting
• The University of Texas Health Science Center at Houston, Houston, Texas · Recruiting
• Central Texas Neurology Consultants, Round Rock, Texas · Recruiting
• The University of Texas Health Science Center, San Antonio, Texas · Recruiting
• Re:Cognition Health, Fairfax, Virginia · Recruiting
• EvergreenHealth, Kirkland, Washington · Not yet recruiting
• Memory Clinic Ochanomizu, Bunkyō City, Japan · Recruiting
• Shonan Keiiku Hospital, Fujisawa, Japan · Not yet recruiting
• Hyogo Prefectural Harima-Himeji General Medical Center, Himeji, Japan · Recruiting
• Inage Neurology and Memory Clinic, Inage, Japan · Recruiting
• Nippon Medical School Musashi Kosugi Hospital, Kawasaki, Japan · Not yet recruiting
• St. Marianna University Hospital, Kawasaki, Japan · Not yet recruiting
• Kobe University Hospital, Kobe, Japan · Recruiting
• Juntendo Tokyo Koto Geriatric Medical Center, Kōtoku, Japan · Not yet recruiting
• Katayama Medical Clinic, Kurashiki, Japan · Recruiting
• Nagoya Ekisaikai Hospital, Nagoya, Japan · Recruiting
• Nagoya University Hospital, Nagoya, Japan · Not yet recruiting
• National Center for Geriatrics and Gerontology, Ōbu, Japan · Recruiting
• The University of Osaka Hospital, Suita, Japan · Not yet recruiting
• Tokyo Metropolitan Institute for Geriatrics and Gerontology, tabashi City, Japan · Not yet recruiting
• Tachikawa Hospital, Tachikawa, Japan · Recruiting
• Memory Clinic Toride, Toride, Japan · Recruiting
• Yokohama Minami Kyosai Hospital, Yokohama, Japan · Not yet recruiting
• Oita University Hospital, Yufu, Japan · Not yet recruiting
• Gangnam Severance Hospital, Yonsei University Health System, Gangnam-gu, South Korea · Not yet recruiting
• Inha University Hospital, Incheon, South Korea · Not yet recruiting
• Gachon University Gil Medical Center, Namdong-gu, South Korea · Not yet recruiting
• Hanyang University Seoul Hospital, Seoul, South Korea · Not yet recruiting
• Konkuk University Medical Center, Seoul, South Korea · Not yet recruiting
• Ewha Womans University Mokdong Hospital, Seoul, South Korea · Not yet recruiting
• Taipei Medical University Shuang Ho Hospital, New Taipei City, Taiwan · Not yet recruiting
• New Taipei Municipal TuCheng Hospital, New Taipei City, Taiwan · Not yet recruiting
• National Cheng Kung University Hospital, Tainan, Taiwan · Not yet recruiting
• National Taiwan University Hospital, Taipei, Taiwan · Not yet recruiting
• Taipei Veterans General Hospital, Taipei, Taiwan · Not yet recruiting
• Chang Gung Medical Foundation-Linkou Branch, Taoyuan, Taiwan · Not yet recruiting