RightFit
RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether donanemab slows the loss of thinking skills and the ability to do daily tasks. It is for people with early thinking and memory decline who meet certain symptom and test requirements. Each person will be in the study for one and a half years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have thinking or memory problems that have slowly gotten worse for at least 6 months.
  • Have at least 1 main symptom of dementia with Lewy bodies, a disease that affects the brain.
  • Score at least 20 on the Montreal Cognitive Assessment (MoCA), a test of thinking and memory.
  • Meet the study's requirements for a blood test called P-tau217.
  • Have a spinal fluid test showing signs of abnormal amyloid protein in the brain.
  • Have a spinal fluid test showing signs of abnormal alpha-synuclein protein.
  • Have at least 1 reliable study partner who has frequent contact with you and knows your daily skills and behavior. This person must agree in writing to take part.

Who can't join

  • Have an illness that could interfere with the study, or a current serious illness or one that is not stable.
  • Have, or may have, another major brain or nervous system disease that could affect thinking or your ability to finish the study.
  • Have had cancer that the study doctor thinks has a high risk of coming back and keeping you from finishing the study.
  • Have multiple or severe drug allergies, a major tendency toward allergic conditions, or severe allergic reactions after treatment.
  • Have received treatment that targets amyloid, or active immunization against amyloid-beta, such as a vaccine.
  • Have an MRI scan that does not meet the study's entry rules.
  • Have a condition that makes MRI or PET scans unsafe or unsuitable.
  • Have a condition that makes a lumbar puncture, a procedure to collect spinal fluid, unsafe or unsuitable.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (42)

AZ

CA

CO

  • CenExel Rocky Mountain Clinical Research · Englewood, CO 80113Meagen Salinas · Principal investigatorMore trials in Englewood

CT

  • Ki Health Partners, LLc, dba New England Institute for Clinical Research · Stamford, CT 06905 · Study contact · 203-914-1903Peter McAllister · Principal investigatorMore trials in Stamford

FL

IN

KS

MA

MI

MN

MO

OR

PA

TX

VA

WA