What side effects are associated with this type of intervention?

The most common treatments for Alzheimer's Disease, particularly monoclonal antibodies like Aducanumab that target amyloid beta plaques, are associated with several side effects. These include amyloid-related imaging abnormalities (ARIA), which can manifest as brain swelling (edema) or small brain bleeds (microhemorrhages). Other potential side effects include headache, dizziness, and infusion-related reactions such as nausea and hypersensitivity. Regular brain MRI scans are often required to monitor for these side effects. Additionally, general treatments for Alzheimer's may cause gastrointestinal issues, cardiovascular events, and neuropsychiatric symptoms.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease, with a focus on monoclonal antibodies targeting amyloid beta plaques. Aducanumab, approved in June 2021, is a notable example, designed to reduce amyloid beta plaques in the brain. Another similar treatment is Lecanemab, which also targets amyloid beta and was granted accelerated approval in January 2023. These treatments aim to slow the progression of Alzheimer's by addressing one of its core pathological features.

What other types of research exist?

Promising novel alternatives to Aducanumab for Alzheimer's Disease patients in 2024 include Lecanemab and Donanemab, both of which are monoclonal antibodies targeting amyloid beta plaques. Additionally, therapies targeting tau protein, such as anti-tau antibodies, and BACE inhibitors, which reduce amyloid beta production, are also being explored as potential treatments.

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Monoclonal Antibodies

Aducanumab for Alzheimer's Disease

Phase 3

Waitlist Available

Research Sponsored by Biogen

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

History of or known seropositivity for HIV.

A seizure event that occurred after the last visit of the feeder study and before Screening for this study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 100

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing the safety of aducanumab, a drug that may help clear harmful proteins from the brain, in people who have already taken it. Aducanumab aims to reduce the accumulation of these proteins and slow cognitive impairment in Alzheimer's disease.

Who is the study for?

This trial is for individuals with Alzheimer's who were part of previous aducanumab studies. They must have finished the initial study period, tolerated a specific dose well, and have a care partner to report on their cognitive abilities. People with recent serious health issues or certain medical conditions are excluded.

What is being tested?

The trial tests the safety and tolerability of aducanumab in people with Alzheimer's over 100 weeks after they've had a break from earlier related trials. It includes those who previously received aducanumab as well as those who initially got a placebo.

What are the potential side effects?

While not explicitly listed here, common side effects of aducanumab may include reactions at the injection site, headaches, falls, diarrhea or other digestive issues, and potential changes in mental status.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have tested positive for HIV.

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I had a seizure between my last doctor's visit and now.

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My liver isn't working properly, as shown by recent tests.

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I have not had a serious illness or infection in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 100

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 100

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 100 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Core Treatment Period: Number of Participants With Antidrug Antibodies (ADAs) in Serum

Core Treatment Period: Number of Participants with AEs Leading to Treatment Discontinuation or Study Withdrawal

Core Treatment Period: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

+2 more

Side effects data

From 2023 Phase 3 trial • 148 Patients • NCT05108922

23%

Amyloid related imaging abnormality-oedema/effusion

14%

Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits

12%

Headache

Superficial siderosis of central nervous system

Covid-19

Fall

Benign prostatic hyperplasia

Nausea

Fatigue

Infusion related reaction

Gastroenteritis

Nasopharyngitis

Sinusitis

Back pain

Cataract

Chest pain

Dizziness

Oedema peripheral

Hypertensive urgency

Sars-cov-2 test positive

Hyponatraemia

Lacunar infarction

Diarrhoea

Urinary tract infection

Toothache

Osteoarthritis

Lymphocytosis

Hyperlipidaemia

Neck pain

Muscle discomfort

Asthenia

Thrombocytopenia

Hyperbilirubinaemia

Influenza

Ageusia

Cough

Spinal compression fracture

Infusion site reaction

Pain

Non-cardiac chest pain

Hyperglycaemia

Rash erythematous

Rotator cuff syndrome

Epiretinal membrane peel

Ejection fraction decreased

Hepatic enzyme abnormal

Syncope

Cholecystitis

Gastrooesophageal reflux disease

Peripheral artery aneurysm

Transient ischaemic attack

Rash

Vomiting

Bronchitis

Cerebral microhaemorrhage

Nerve compression

Anxiety

Depressed mood

Pain in extremity

Benign tumour excision

Atrioventricular block second degree

Anaemia

Haemarthrosis

Infusion site extravasation

Fibromyalgia

Muscular weakness

Bradycardia

Dysphagia

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Aducanumab

Donanemab

Awards & Highlights

Pivotal Trial

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AducanumabExperimental Treatment1 Intervention

Participants will be administered aducanumab 10 milligrams per kilogram (mg/kg) by intravenous (IV) infusions every four weeks (Q4W) for a duration of 100 weeks during the Core Treatment Period. Eligible participants will continue to receive aducanumab 10 mg/kg IV infusion, Q4W, for 52 weeks during the Long-Term Extension (LTE) Treatment Period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aducanumab

2022

Completed Phase 3

~330

0 / 4Eligibility criteria met

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 monoclonal antibodies like Aducanumab, which target amyloid-beta plaques in the brain. These plaques are believed to contribute to the neurodegenerative process in Alzheimer's by disrupting cell function and triggering inflammation. By binding to and promoting the clearance of these plaques, monoclonal antibodies aim to slow disease progression and improve cognitive function. This mechanism is crucial for Alzheimer's patients as it directly addresses one of the core pathological features of the disease. Other treatments, such as cholinesterase inhibitors and NMDA receptor antagonists, work by enhancing neurotransmitter function to temporarily alleviate symptoms but do not modify the underlying disease process.

Impact of Anti-amyloid-β Monoclonal Antibodies on the Pathology and Clinical Profile of Alzheimer's Disease: A Focus on Aducanumab and Lecanemab.Lessons Learnt from the Second Generation of Anti-Amyloid Monoclonal Antibodies Clinical Trials.