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

NCT07589595
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
350
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Start date
2026-05-20
clinicaltrials.gov
Number of sites
72
clinicaltrials.gov

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.
clinicaltrials.gov
Short title
A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
clinicaltrials.gov
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
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2028-08-01
clinicaltrials.gov
First posted
2026-05-15
clinicaltrials.gov
Registry last updated
2026-08-25
clinicaltrials.gov
Primary completion date
2028-08-01
clinicaltrials.gov
Start date
2026-05-20
clinicaltrials.gov

Participants
350
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
350
clinicaltrials.gov
Protocol amendments
0
clinicaltrials.gov
Number of sites
72
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07589595
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07589595
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB)

    Timeframe: Baseline through Week 52

  1. Change from Baseline for Integrated Alzheimer's Disease Rating Scale (iADRS)

    Timeframe: Baseline through Week 52

  2. Change from Baseline for Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13 items (ADAS-Cog13)

    Timeframe: Baseline through Week 52

  3. Change from Baseline for Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living Inventory (ADCS-iADL)

    Timeframe: Baseline through Week 52

  4. Time to Clinical Progression of Dementia as Measured by Clinical Dementia Rating - Global Score (CDR-GS)

    Timeframe: Baseline through Week 52

  5. Change from Baseline in Brain Amyloid Plaque Levels

    Timeframe: Baseline through Week 52

  6. Trough Concentration at Steady State

    Timeframe: Baseline through Week 52

  7. Maximum Concentration at Steady State

    Timeframe: Baseline through Week 52

  8. Antidrug Antibodies (ADA) Against Donanemab

    Timeframe: Baseline through Week 52

  9. Frequency of Neutralizing Antibodies to Donanemab Treatment-Emergent ADA-Positive Participants

    Timeframe: Baseline through Week 52

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
55 Years
Maximum age
85 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • TrialSphere CorpChandler, United StatesRecruiting
  • HonorHealth Research InstituteScottsdale, United StatesNot yet recruiting
  • Profound Research LLCCarlsbad, United StatesRecruiting
  • Irvine Clinical ResearchIrvine, United StatesRecruiting
  • UCSD - Altman Clinical and Translational Research Institute (ACTRI)La Jolla, United StatesNot yet recruiting
  • Stanford Neuroscience Health CenterPalo Alto, United StatesNot yet recruiting
  • CenExel Rocky Mountain Clinical ResearchEnglewood, United StatesNot yet recruiting
  • Ki Health Partners, LLc, dba New England Institute for Clinical ResearchStamford, United StatesNot yet recruiting
  • JEM Research InstituteAtlantis, United StatesRecruiting
  • VIN - AventuraAventura, United StatesRecruiting
  • Brain Matters ResearchDelray Beach, United StatesRecruiting
  • Neuropsychiatric Research Center of Southwest FloridaFort Myers, United StatesRecruiting
  • Norman Fixel Institute for Neurological Diseases (FIND)Gainesville, United StatesNot yet recruiting
  • Mayo Clinic in FloridaJacksonville, United StatesNot yet recruiting
  • K2 Medical Research ORLANDOMaitland, United StatesRecruiting
  • BRP-Kendal LakesMiami, United StatesRecruiting
  • Renstar Medical ResearchOcala, United StatesRecruiting
  • Charter Research - OrlandoOrlando, United StatesRecruiting
  • Axiom Brain Health LLCTampa, United StatesRecruiting
  • Palm Beach NeurologyWest Palm Beach, United StatesRecruiting
  • Conquest ResearchWinter Park, United StatesRecruiting
  • Indiana University Health Neuroscience CenterIndianapolis, United StatesRecruiting
  • The University of Kansas - Clinical Research CenterFairway, United StatesNot yet recruiting
  • Massachusetts General Hospital - CharlestownCharlestown, United StatesNot yet recruiting
  • K2 Medical Research - FoxboroughFoxborough, United StatesRecruiting

And 47 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • I5T-MC-AACV
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (4)

Targets (1)