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The trial is taking place at:
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Irvine Clinical Research | Irvine, CA

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A Donanemab (LY3002813) Prevention Study in Participants With Alzheimer's Disease (TRAILBLAZER-ALZ 3)

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Lilly

Status and phase

Enrolling
Phase 3

Conditions

Alzheimer Disease

Treatments

Drug: Donanemab
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05026866
18284
I5T-MC-AACM (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer's Disease (AD).

Enrollment

2,600 estimated patients

Sex

All

Ages

65 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • A Telephone Interview for Cognitive Status - modified (TICS-M) score reflective of intact cognitive functioning.
  • Has a phosphorylated tau (P-tau) result consistent with the presence of amyloid and early-tau pathology.
  • Has a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
  • Have adequate literacy, vision, and hearing for neuropsychological testing at screening.
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
  • Female participants include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis; or post menopausal (women 55 or older not on hormone therapy and had at least 12 months of spontaneous amenorrhea; or with a diagnosis of menopause prior to starting hormone replacement therapy.

Exclusion criteria

  • Mild cognitive impairment or dementia, or significant other neurodegenerative disease that can affect cognition.
  • Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease that could interfere with the analysis of the study or a life expectancy of approximately ≤5 years.
  • History of cancer with high risk of recurrence and preventing completion of the trial.
  • History of clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and/or exfoliative dermatitis).
  • Have any clinically important abnormality at screening on magnetic resonance imaging (MRI) or clinical laboratory test results that could be detrimental to the participant or study integrity.
  • Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
  • Have a centrally read MRI demonstrating presence of amyloid-related imaging abnormalities (ARIA-E), >4 cerebral microhemorrhages, more than 1 area of superficial siderosis, any macrohemorrhage or severe white matter disease at screening.
  • Have had prior treatment with a passive anti-amyloid immunotherapy <5 half-lives prior to randomization.
  • Have received active immunization against amyloid beta (Aβ) in any other study.
  • Have received active immunization against Aβ in any other study.
  • Current or previous use of prescription medications used as treatment for mild cognitive impairment (MCI) or AD.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

2,600 participants in 2 patient groups, including a placebo group

Donanemab
Experimental group
Description:
Donanemab administered intravenously (IV)
Treatment:
Drug: Donanemab
Placebo
Placebo Comparator group
Description:
Placebo is administered intravenously
Treatment:
Drug: Placebo

Trial contacts and locations

232

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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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