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Monoclonal Antibodies
A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)
Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months and 18 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is comparing two medications, donanemab and aducanumab, to see which is better at removing harmful protein clumps from the brains of people with early Alzheimer's disease. These protein clumps, called amyloid plaques, are thought to contribute to the symptoms of Alzheimer's. The goal is to find out if one medication is more effective than the other in helping patients. Aducanumab is the first FDA-approved drug that targets amyloid plaques in Alzheimer's disease, while donanemab is an antibody targeting a modified form of amyloid-β.
Eligible Conditions
- Alzheimer's Disease
- Mild Cognitive Impairment
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months and 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months and 18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Low/Medium (Intermediate) Tau Subpopulation (Superiority) on Donanemab Versus Aducanumab
Mean Absolute Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Non-inferiority) on Donanemab 6 Months Versus Aducanumab 12 Months
Mean Absolute Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Non-inferiority) on Donanemab 6 Months Versus Aducanumab 18 Months
+7 moreSide effects data
From 2023 Phase 3 trial • 148 Patients • NCT0510892233%
Amyloid related imaging abnormality-oedema/effusion
25%
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
19%
Covid-19
14%
Headache
10%
Superficial siderosis of central nervous system
7%
Fall
6%
Nausea
4%
Fatigue
4%
Benign prostatic hyperplasia
4%
Diarrhoea
4%
Back pain
4%
Cataract
4%
Dizziness
4%
Infusion site extravasation
4%
Upper respiratory tract infection
4%
Tooth infection
4%
Nasopharyngitis
3%
Hypertensive urgency
3%
Infusion related reaction
3%
Gastroenteritis
3%
Rotator cuff syndrome
3%
Coronary artery disease
3%
Muscle spasms
3%
Sinusitis
3%
Arthralgia
3%
Chest pain
3%
Rash
3%
Oedema peripheral
3%
Muscular weakness
3%
Hypertension
3%
Urinary tract infection
1%
Sars-cov-2 test positive
1%
Bronchitis
1%
Ageusia
1%
Lacunar infarction
1%
Osteoarthritis
1%
Hyperlipidaemia
1%
Lymphocytosis
1%
Toothache
1%
Non-cardiac chest pain
1%
Neck pain
1%
Gastritis
1%
Ocular procedural complication
1%
Muscle discomfort
1%
Asthenia
1%
Thrombocytopenia
1%
Hyperbilirubinaemia
1%
Cough
1%
Spinal compression fracture
1%
Infusion site reaction
1%
Pain
1%
Hyperglycaemia
1%
Gait disturbance
1%
Hypervolaemia
1%
Transient ischaemic attack
1%
Epiretinal membrane peel
1%
Iron deficiency anaemia
1%
Leukocytosis
1%
Lymphopenia
1%
Atrial fibrillation
1%
Cardiomegaly
1%
Tinnitus
1%
Visual field defect
1%
Eructation
1%
Gastric polyps
1%
Gingival swelling
1%
Inguinal hernia
1%
Conjunctivitis
1%
Gastroenteritis viral
1%
Influenza
1%
Lower respiratory tract infection
1%
Viral infection
1%
Arthropod bite
1%
Facial bones fracture
1%
Pelvic fracture
1%
Shoulder fracture
1%
Skin abrasion
1%
Blood cholesterol increased
1%
Hepatic enzyme increased
1%
Weight decreased
1%
Hypomagnesaemia
1%
Ejection fraction decreased
1%
Hepatic enzyme abnormal
1%
Hyponatraemia
1%
Groin pain
1%
Intervertebral disc protrusion
1%
Joint swelling
1%
Myalgia
1%
Scoliosis
1%
Basal cell carcinoma
1%
Osteoma
1%
Cerebral haemorrhage
1%
Migraine
1%
Neuropathy peripheral
1%
Paraesthesia
1%
Somnolence
1%
Agitation
1%
Confusional state
1%
Depression
1%
Initial insomnia
1%
Mood altered
1%
Nocturia
1%
Pollakiuria
1%
Urinary retention
1%
Pulmonary mass
1%
Dermatitis
1%
Hyperkeratosis
1%
Aortic aneurysm
1%
Peripheral arterial occlusive disease
1%
Parotid duct obstruction
1%
Rash erythematous
1%
Syncope
1%
Cholecystitis
1%
Gastrooesophageal reflux disease
1%
Peripheral artery aneurysm
1%
Vomiting
1%
Cerebral microhaemorrhage
1%
Nerve compression
1%
Anxiety
1%
Depressed mood
1%
Pain in extremity
1%
Benign tumour excision
1%
Atrioventricular block second degree
1%
Anaemia
1%
Haemarthrosis
1%
Fibromyalgia
1%
Bradycardia
1%
Dysphagia
1%
Obstructive sleep apnoea syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aducanumab
Donanemab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DonanemabExperimental Treatment1 Intervention
Donanemab is administered intravenously (IV) every 4 weeks (Q4W).
Group II: AducanumabActive Control1 Intervention
Aducanumab administered IV per US label.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Donanemab
2017
Completed Phase 3
~500
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,679 Previous Clinical Trials
3,465,605 Total Patients Enrolled
Study DirectorEli Lilly and Company
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The investigator believes that the participant has adequate literacy, vision, and hearing to complete neuropsychological testing.You or someone close to you has noticed a decline in your memory over a period of at least 6 months.You have mild to moderate dementia, as determined by a clinical assessment called the Clinical Dementia Rating (CDR) scale.You have a serious neurological condition that affects your brain, such as dementia, Parkinson's disease, or a history of stroke or seizures.You have previously participated in a study focused on treating Amyloid beta with immunotherapy, or you are currently participating in such a study.You have been treated with donanemab or aducanumab in the past or are currently receiving treatment with them.You are allergic to donanemab or aducanumab, or any of the ingredients in the medication.You have a history of bleeding disorder or take medications that prevent blood from clotting, except for low-dose aspirin.You or someone who knows you well has noticed a consistent decline in your memory over the past 6 months or longer.You have had serious allergic reactions to multiple medications in the past, or severe skin reactions after taking medication.You have a mild cognitive impairment or early-stage dementia, as determined by a specific assessment called the Clinical Dementia Rating (CDR).
Research Study Groups:
This trial has the following groups:- Group 1: Donanemab
- Group 2: Aducanumab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05108922 — Phase 3