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

PHASE3RECRUITING

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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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) with the presence of brain tau pathology.

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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 Day 601 or 1.

Meet flortaucipir F18 scan (central read) criteria

Meet florbetapir F18 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 affect 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

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Eligibility

Age eligible for study : 60 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-10-10

Primary completion: 2027-04-16

Study completion finish: 2027-04-30

Study type

TREATMENT

Phase

PHASE3

Trial 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

Condition: Alzheimer Disease, Dementia and more
DRUG: Donanemab and other drugs
Sydney, New South Wales, Australia and more
Sponsor: Eli Lilly and Company

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

St Vincent's Hospital

Research sites nearby

Select from list below to view details:

St Vincent's Hospital
Sydney, New South Wales, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia

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 Participants will receive donanemab intravenously (IV)	DRUG: Donanemab Administered IV
PLACEBO_COMPARATOR: Placebo Participants will receive placebo IV	DRUG: Placebo Administered IV

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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 the overall population'.	Baseline, Week 76

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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 or 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 at least one of 'the low-medium tau pathology population or 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 at least one of 'the low-medium tau pathology population or 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 at least one of 'the low-medium tau pathology population or the overall population'.	Baseline, Week 76
Change from Baseline in Amyloid Plaque Deposition as by Florbetapir F18 Positron Emission Tomography (PET) Scan	Not Specified	Baseline, Week 76
Pharmacokinetics (PK): Average Serum Concentration of Donanemab	Not Specified	Baseline to Week 76
Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs)	Not Specified	Week 76
Change from Baseline in Quality of Life in Alzheimer's Disease (QOL-AD)	Change from baseline in the QoL-AD in at least one of 'the low-medium tau pathology population or the overall population'.	Baseline, Week 76
Change from Baseline in Resource Utilization in Dementia - Lite Version (RUD-Lite)	Change from baseline in the RUD-Lite in at least one of 'the low-medium tau pathology population or the overall population'.	Baseline, Week 76
Change from Baseline in Neuropsychiatric Inventory (NPI)	Change from baseline in the NPI in at least one of 'the low-medium tau pathology population or the overall population'.	Baseline, Week 76

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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