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The trial is taking place at:
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Adams Clinical | Watertown, MA

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A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

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Lilly

Status and phase

Enrolling
Phase 3

Conditions

Alzheimer's Disease
Mental Disorders
Neurodegenerative Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Dementia
Brain Diseases

Treatments

Drug: Placebo
Drug: Donanemab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05738486
U1111-1285-9438 (Other Identifier)
2022-502268-18-00 (Other Identifier)
I5T-MC-AACQ (Other Identifier)
18648

Details and patient eligibility

About

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA.

Enrollment

800 estimated patients

Sex

All

Ages

60 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Gradual and progressive change in memory function reported by the participant or informant for ≥6 months.
  • A mini mental state examination (MMSE) score of 20 to 28 (inclusive) at screening.
  • Have an amyloid PET scan result from central read, consistent with the presence of amyloid pathology.

Exclusion criteria

  • Have significant neurological disease affecting the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures, except febrile childhood seizures.
  • Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study.
  • A life expectancy of <24 months
  • Have a presence or history of malignant neoplasms within the past 5 years prior to Visit 1.

Exceptions:

  • non-metastatic basal- or squamous-cell skin cancer

  • Stage 0 non-invasive carcinoma of the cervix

  • Stage 0 non-invasive prostate cancer, or

  • other cancers with low risk of recurrence or spread

    • Contraindication to MRI or PET scans
    • Have had prior treatment with a passive anti-amyloid immunotherapy.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

800 participants in 4 patient groups

Donanemab Dose Level 1
Experimental group
Description:
Participants will receive donanemab by intravenously (IV) infusion. Participants will receive placebo at certain intervals to preserve the blind.
Treatment:
Drug: Donanemab
Drug: Placebo
Donanemab Dose Level 2
Experimental group
Description:
Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind.
Treatment:
Drug: Donanemab
Drug: Placebo
Donanemab Dose Level 3
Experimental group
Description:
Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind.
Treatment:
Drug: Donanemab
Drug: Placebo
Donanemab Dose Level 4
Experimental group
Description:
Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind.
Treatment:
Drug: Donanemab
Drug: Placebo

Trial contacts and locations

49

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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