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Monoclonal Antibodies

Donanemab for Early Alzheimer's Disease

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
Must not have
Current treatment with immunoglobulin G (IgG) therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16 to week 20
Awards & highlights
Pivotal Trial

Summary

This trial is testing donanemab, a drug for early Alzheimer's disease. It targets people with early symptoms and specific brain changes. The drug helps remove harmful proteins from the brain, potentially slowing down or improving symptoms.

Who is the study for?
This trial is for people with early Alzheimer's who've had memory changes for at least 6 months, scoring 20-28 on the MMSE (a cognitive test). They must meet specific criteria on PET scans and have a partner to consent to participate. Those who can't undergo MRI or PET scans or are currently on IgG therapy cannot join.
What is being tested?
The study is testing the safety and effectiveness of Donanemab in treating early Alzheimer's disease. Participants will either receive Donanemab or a placebo. An additional group will be openly given Donanemab to assess its safety further.
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions related to immune system activation, as it is common with monoclonal antibodies like Donanemab.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently receiving IgG therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16 to week 20
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 to week 20 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population)
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population)
Secondary study objectives
Change From Baseline in Brain Amyloid Plaque Deposition as Measured by Amyloid Positron Emission Tomography (PET) Scan
Change From Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan
Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)
+10 more

Side effects data

From 2023 Phase 3 trial • 148 Patients • NCT05108922
21%
Amyloid related imaging abnormality-oedema/effusion
14%
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
14%
Covid-19
8%
Headache
7%
Infusion related reaction
4%
Arthralgia
4%
Dizziness
3%
Pneumonia
3%
Constipation
3%
Vertigo
3%
Upper respiratory tract infection
3%
Anxiety
3%
Nasopharyngitis
3%
Dyspnoea
1%
Basal cell carcinoma
1%
Gastritis
1%
Tooth abscess
1%
Chest pain
1%
Fall
1%
Oedema peripheral
1%
Tooth infection
1%
Gastrooesophageal reflux disease
1%
Hypertriglyceridaemia
1%
Dry skin
1%
Ingrowing nail
1%
Deep vein thrombosis
1%
Hypersensitivity
1%
Campylobacter infection
1%
Sinusitis
1%
Syncope
1%
Mental status changes
1%
Hypertonic bladder
1%
Diverticulitis
1%
Pneumomediastinum
1%
Skin laceration
1%
Rib fracture
1%
Diarrhoea
1%
Infusion site reaction
1%
Knee arthroplasty
1%
Meniere's disease
1%
Macular hole
1%
Alanine aminotransferase increased
1%
Aspartate aminotransferase increased
1%
Gout
1%
Pruritus
1%
Pain in extremity
1%
Abdominal discomfort
1%
Ear infection
1%
Urinary tract infection
1%
Pneumothorax
1%
Hypotension
1%
Pulmonary embolism
1%
Palpitations
1%
Onychomycosis
1%
Back pain
1%
Sepsis
1%
Tachycardia
1%
Disturbance in attention
1%
Affective disorder
1%
Food poisoning
1%
Feeling abnormal
1%
Cough
1%
Insomnia
1%
Nephrolithiasis
1%
Pericardial effusion
1%
Nausea
1%
Large intestinal polypectomy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donanemab
Aducanumab

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DonanemabExperimental Treatment1 Intervention
Participants received 700 milligram (mg) Donanemab every 4 weeks (Q4W) x 3 doses, then 1400 mg Q4W given intravenously (IV) for up to 72 weeks
Group II: PlaceboPlacebo Group1 Intervention
Participants received placebo given IV.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Donanemab
2017
Completed Phase 3
~500

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Alzheimer's Disease include cholinesterase inhibitors (such as donepezil, rivastigmine, and galantamine), NMDA receptor antagonists (like memantine), and monoclonal antibodies targeting amyloid-beta plaques (such as donanemab). Cholinesterase inhibitors work by increasing levels of acetylcholine, a neurotransmitter important for memory and learning, thereby providing modest symptomatic relief. NMDA receptor antagonists help regulate glutamate activity to prevent excitotoxicity, which can damage neurons. Monoclonal antibodies like donanemab target and help clear amyloid-beta plaques, which are believed to play a key role in the pathogenesis of Alzheimer's. These treatments are crucial as they aim to alleviate symptoms and potentially modify disease progression, improving the quality of life for patients.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,651 Previous Clinical Trials
3,222,731 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,369 Previous Clinical Trials
419,658 Total Patients Enrolled

Media Library

Donanemab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04437511 — Phase 3
Alzheimer's Disease Research Study Groups: Donanemab, Placebo
Alzheimer's Disease Clinical Trial 2023: Donanemab Highlights & Side Effects. Trial Name: NCT04437511 — Phase 3
Donanemab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04437511 — Phase 3
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT04437511 — Phase 3
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