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

Investigating the Effects of an Investigational Medication on Early Cognitive Decline in Individuals with Dementia with Lewy Bodies

Primary Investigator
J

Jared Brosch, MD

Primary Investigator

Enrolling By Invitation
55 years - 85 years
All
Phase 2
350 participants needed
1 Location

Brief description of study

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential participants will be recruited by researchers and contacted directly by e-mail, mail, phone, appointment or via clinician referral.

Detailed description of study

8Brief Summary: This study will assess whether treatment with donanemab slows the progression of cognitive and functional decline, as measured by change from baseline through Week 52 on Clinical Dementia Rating - Sum of Boxes, in participants who have mild cognitive impairment, at least 1 core feature of DLB, and biomarkers of alpha-synuclein and amyloid co-pathology. The safety of donanemab treatment and other secondary outcomes also will be assessed.

The total study duration for an individual participant is up to about 79 weeks:
● Prescreening and Screening period - no more than about 19 weeks in total
● Double-Blind Treatment period - about 52 weeks, and
● Follow-up period - about 8 weeks.

During the treatment period, visits occur at about 4-week intervals.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cognitive Dysfunction, Early Cognitive Decline, Lewy Body Disease, Synucleinopathies, Amyloid
  • Age: 55 years - 85 years
  • Gender: All

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.

This study investigates the effects of an investigational medication on individuals experiencing early cognitive decline. Cognitive decline refers to difficulties in thinking, learning, remembering, paying attention, and making decisions. Functional decline refers to challenges in performing daily activities. Participants in this study have been experiencing a gradual decline in these areas for at least six months and show clinical features of dementia with Lewy bodies.

Participants will undergo various procedures to assess their cognitive and functional abilities. These procedures include cognitive assessments and tests to measure changes in brain activity. Participants will also provide samples for analysis to check for specific proteins in the brain related to amyloid and alpha-synuclein pathology.

  • Who can participate: Participants must be adults who have experienced cognitive decline for at least 6 months and have a score of 20 or higher on the Montreal Cognitive Assessment. They should meet specific criteria for brain pathology and have a reliable study partner.
  • Study details: Participants will engage in assessments to measure cognitive and functional changes. They may receive a placebo, an inactive substance that looks like the investigational medicine but does not contain any medicine, for comparison. Participants will also undergo tests and provide samples for analysis to monitor changes.
  • Study timelines: The study will last one and a half years.
Updated on 15 Sep 2026. Study ID: 31147
Please visit our main page to search for other studies you may be interested in. If you need help finding a study or have any questions, please contact us at inhealth@iu.edu

Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only