A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)
PHASE3ACTIVE_NOT_RECRUITING
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT05508789
Intervention or treatment
DRUG: Donanemab
DRUG: Placebo
Conditions
- Alzheimer Disease
- Dementia
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Tauopathies
- Neurodegenerative Diseases
- Neurocognitive Disorders
- Mental Disorders
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Emeritus Research
Select from list below to view details:
Emeritus Research
Botany, Australia
Box Hill Hospital
Box Hill, Australia
The Prince Charles Hospital
Brisbane, Australia
NeuroCentrix
Carlton, Australia
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Who is running the clinical trial?
ELaC
Eli Lilly and Company
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Donanemab
| Drug: Donanemab |
PLACEBO_COMPARATOR: Placebo
| Drug: Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) | 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. | Baseline, Week 76 |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline on the iADRS | Change from baseline on the iADRS in the overall population. | Baseline, Week 76 |
| Change from Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) | 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. | Baseline, Week 76 |
| Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score | 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. | Baseline, Week 76 |
| Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL) Score | 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. | Baseline, Week 76 |
| Change from Baseline on the Mini Mental State Examination (MMSE) Score | 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. | Baseline, Week 76 |
| Change from Baseline in Amyloid Plaque Deposition as by Amyloid Positron Emission Tomography (PET) Scan | Change in brain amyloid plaque deposition in the overall population. | Baseline, Week 76 |
| Pharmacokinetics (PK): Trough Serum Concentration of Donanemab | Not Specified | Baseline to Week 76 |
| Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs) | Not Specified | Week 76 |
Are you running this trial?If you're a clinic or sponsor, you can claim this study.
References
Clinical Trials Gov: A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)Other trials to consider
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