A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

NCT05508789
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
1,500
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Lead sponsor
Eli Lilly and Company
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Start date
2022-10-10
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Number of sites
141
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Summary
The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.
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Short title
A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)
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Official title
Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-07-01
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First posted
2022-08-19
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Registry last updated
2026-07-16
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Primary completion date
2028-05-01
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Start date
2022-10-10
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Participants
1,500
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Participant count basis
Estimated
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Planned participants
1,500
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Protocol amendments
2
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Number of sites
141
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05508789
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ClinicalTrials.gov ID
NCT05508789
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

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

    Timeframe: Baseline, Week 76

    Change from Baseline on the iADRS in at least one of the low-medium tau pathology population or no-very low and low-medium tau pathology population.

  1. Change from Baseline on the iADRS

    Timeframe: Baseline, Week 76

    Change from baseline on the iADRS in the overall population.

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

    Timeframe: Baseline, Week 76

    Change from Baseline CDR-SB in at least one of the low-medium tau pathology population, no-very low and low-medium tau pathology populations, and the overall population.

  3. Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score

    Timeframe: Baseline, Week 76

    Change from Baseline on the ADAS-Cog13 Score in the low-medium tau pathology population, no-very low and low-medium tau pathology populations, and the overall population.

  4. Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL) Score

    Timeframe: Baseline, Week 76

    Change from Baseline ADCS-iADL Score in the low-medium tau pathology population, no-very low and low-medium tau pathology populations, and the overall population.

  5. Change from Baseline on the Mini Mental State Examination (MMSE) Score

    Timeframe: Baseline, Week 76

    Change from Baseline on the MMSE Score in the low-medium tau pathology population, no-very low and low-medium tau pathology populations, and the overall population.

  6. Change from Baseline in Amyloid Plaque Deposition as by Amyloid Positron Emission Tomography (PET) Scan

    Timeframe: Baseline, Week 76

    Change in brain amyloid plaque deposition in the overall population.

  7. Pharmacokinetics (PK): Trough Serum Concentration of Donanemab

    Timeframe: Baseline to Week 76

  8. Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs)

    Timeframe: Week 76

Sources for outcomes
clinicaltrials.gov

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

  • Gradual and progressive change in memory function reported by the participant or informant for ≥6 months.

  • A MMSE score of 20 to 28 (inclusive) at screening visit.

  • Meet amyloid scan (central read) criteria.

  • Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to the study or be available by telephone at designated times.

  • A second study partner may serve as backup. The study partner(s) is/are required to accompany the participant for signing consent. The study partner must be present on all days the cognitive and functional scales are administered.

  • If a participant has a second study partner, it is preferred that 1 study partner be primarily responsible for the CDR and the ADCS-ADL assessments.

  • Days requiring the following assessments and scales must have a study partner available by telephone if not accompanying participant for the following assessments

    • AEs and concomitant medications
    • CDR, and
    • ADCS-ADL

  • Stable concomitant symptomatic AD medications and other medications that may impact cognition for at least approximately 30 days prior to randomization.

  • Has 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; or has a life expectancy of <24 months.
  • History of cancer within the last 5 years, except of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, or other cancers with low risk of recurrence or spread.
  • Contraindication to MRI or PET scans.
Sources for eligibility
clinicaltrials.gov

  • Hospital Italiano de Buenos AiresABB, Argentina
  • Clinica Privada BanfieldBanfield, Argentina
  • Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)Buenos Aires, Argentina
  • Stat Research S.A.Buenos Aires, Argentina
  • Centro de Investigaciones Metabólicas (CINME)Buenos Aires, Argentina
  • CIPRECBuenos Aires, Argentina
  • Mautalen Salud e InvestigaciónBuenos Aires, Argentina
  • Centro Medico Dra. Laura Maffei- Investigacion Clinica AplicadaBuenos Aires, Argentina
  • Centro Médico ArsemaBuenos Aires, Argentina
  • Instituto Geriatrico Nuestra Señora de Las NievesBuenos Aires, Argentina
  • Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • IDIM - Instituto de Investigaciones MetabólicasCiudad de Buenos Aires, Argentina
  • INSA Instituto de Neurociencia San AgustinLa Plata, Argentina
  • Instituto De Investigaciones Clinicas QuilmesQuilmes, Argentina
  • INECO Neurociencias OroñoRosario, Argentina
  • Emeritus ResearchBotany, Australia
  • Box Hill HospitalBox Hill, Australia
  • The Prince Charles HospitalBrisbane, Australia
  • NeuroCentrixCarlton, Australia
  • Central Coast Neurosciences ResearchErina, Australia
  • Austin HealthIvanhoe, Australia
  • Southern NeurologyKogarah, Australia
  • HammondCareMalvern, Australia
  • The Alfred HospitalMelbourne, Australia

And 116 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-522340-40-00
  • I5T-MC-AACO
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (6)

Targets (1)