A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)
- Conditions
- Alzheimer DiseaseDementiaNeurocognitive DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesMental DisordersNeurodegenerative Diseases
- Interventions
- Drug: Placebo
- Registration Number
- NCT05508789
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
TRAILBLAZER-ALZ 5 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) and the presence of AD pathology.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
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Gradual and progressive change in memory function reported by the participant or informant for ≥6 months.
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A MMSE score of 20 to 28 (inclusive) at screening visit.
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Meet amyloid scan (central read) criteria.
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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.
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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.
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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.
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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
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Donanemab Donanemab Participants will receive donanemab intravenously (IV) Placebo Placebo Participants will receive placebo IV
- Primary Outcome Measures
Name Time Method Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) 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.
- Secondary Outcome Measures
Name Time Method Change from Baseline on the Mini Mental State Examination (MMSE) Score 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.
Change from Baseline on the iADRS Baseline, Week 76 Change from baseline on the iADRS in the overall population.
Change from Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) 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.
Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score 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.
Change from Baseline in Amyloid Plaque Deposition as by Amyloid Positron Emission Tomography (PET) Scan Baseline, Week 76 Change in brain amyloid plaque deposition in the overall population.
Pharmacokinetics (PK): Trough Serum Concentration of Donanemab Baseline to Week 76 Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs) Week 76 Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL) Score 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.
Trial Locations
- Locations (140)
Clinica Privada Banfield
🇦🇷Banfield, Buenos Aires, Argentina
IDIM - Instituto de Investigaciones Metabólicas
🇦🇷Ciudad de Buenos Aires, Buenos Aires, Argentina
INSA Instituto de Neurociencia San Agustin
🇦🇷La Plata, Buenos Aires, Argentina
Instituto De Investigaciones Clinicas Quilmes
🇦🇷Quilmes, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
🇦🇷ABB, Ciudad Autónoma De Buenos Aires, Argentina
Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Stat Research S.A.
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
CIPREC
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Mautalen Salud e Investigación
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Scroll for more (130 remaining)Clinica Privada Banfield🇦🇷Banfield, Buenos Aires, Argentina