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

Lilly

Status and phase: Not yet enrolling; Phase 2

Conditions: Synucleinopathies; Amyloid; Cognitive Dysfunction; Lewy Body Disease

Treatments: Drug: Donanemab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07589595

27790

I5T-MC-AACV (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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350 participants in 2 patient groups, including a placebo group

Donanemab (LY3002813)

Experimental group

Description:

Donanemab (LY3002813) administered as an intravenous (IV) infusion

Treatment:

Drug: Donanemab

Placebo

Placebo Comparator group

Description:

Placebo administered IV

Treatment:

Drug: Placebo