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 · NOT_YET_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 · NOT_YET_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 · NOT_YET_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 · NOT_YET_RECRUITING
• Juntendo Tokyo Koto Geriatric Medical Center, Kōtoku, Japan · NOT_YET_RECRUITING
• Katayama Medical Clinic, Kurashiki, Japan · RECRUITING
• Nagoya Ekisaikai Hospital, Nagoya, Japan · NOT_YET_RECRUITING
• Nagoya University Hospital, Nagoya, Japan · NOT_YET_RECRUITING
• National Center for Geriatrics and Gerontology, Ōbu, Japan · NOT_YET_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 · NOT_YET_RECRUITING
• Memory Clinic Toride, Toride, Japan · NOT_YET_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