Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders
Conditions
Keywords
Alzheimer's, Dementia, Cognitive Impairment, Amyloid Plaque
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.
Interventions
DRUGDonanemab
Administered IV
DRUGPlacebo
Administered IV
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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 | — |
Countries
Argentina, Australia, China, Poland, South Korea, Spain, Taiwan, United Kingdom
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed