Summary

Eligibility
for people ages 55-85 (full criteria)
Location
at UCSD
Dates
study started
study ends around
Principal Investigator
by Stephanie Lessig (ucsd)

Description

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.

Official Title

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

Keywords

Cognitive Dysfunction, Lewy Body Disease, Synucleinopathies, Amyloid, Mild Cognitive Impairment, Mild Dementia, Brain Diseases, Nervous System Diseases, Neurodegenerative Diseases, Neurocognitive Disorders, Cognition Disorders, Alzheimer Disease, donanemab, Donanemab (LY3002813)

Eligibility

You can join if…

Open to people ages 55-85

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCSD - Altman Clinical and Translational Research Institute (ACTRI)
    La Jolla California 92037 United States
  • Irvine Clinical Research
    Irvine California 92614 United States
  • Profound Research LLC
    Carlsbad California 92011 United States
  • Stanford Neuroscience Health Center
    Palo Alto California 94304 United States

Lead Scientist at University of California Health

  • Stephanie Lessig (ucsd)
    Clinical Professor, Neurosciences, Vc-health Sciences-schools. Authored (or co-authored) 31 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT07589595
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 350 study participants
Last Updated