What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease that target amyloid-beta plaques, such as Donanemab, include antibody-based therapies like solanezumab and aducanumab. These treatments have been associated with side effects such as infusion-related reactions, amyloid-related imaging abnormalities (ARIA), which can include brain swelling and microhemorrhages, and general symptoms like headache, dizziness, and nausea. Other common Alzheimer's treatments, such as cholinesterase inhibitors (e.g., donepezil) and memantine, can cause gastrointestinal issues, dizziness, and confusion.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease that target amyloid-beta plaques, similar to Donanemab. One notable example is Aducanumab, a monoclonal antibody that reduces amyloid-beta plaques in the brain. Aducanumab was approved based on its ability to decrease amyloid plaques, which are believed to contribute to the progression of Alzheimer's Disease. Other treatments include supportive medications like cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and NMDA receptor antagonists (memantine), which help manage symptoms but do not target amyloid plaques directly.

What other types of research exist?

Promising novel alternatives to Donanemab for Alzheimer's Disease patients in 2024 include: 1) Lecanemab and Aducanumab, which are other antibodies targeting amyloid-beta plaques. 2) Tau protein targeting therapies such as anti-tau antibodies. 3) Anti-inflammatory agents like ALZT-OP1. 4) Neuroprotective strategies including BACE inhibitors and gamma-secretase modulators. These alternatives offer different mechanisms of action and are in various stages of clinical development.

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Monoclonal Antibodies

Donanemab for Alzheimer's Disease

Verified Trial

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

You do *not* have Alzheimer's or dementia

Answer yes if you are *not* currently enrolled in another clinical trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, up to week 182

Awards & highlights

Pivotal Trial

Summary

This trial is testing donanemab, a medication aimed at helping people with Alzheimer's Disease by removing harmful protein clumps from their brains. Donanemab has shown promise in reducing these harmful proteins in Alzheimer's disease.

Who is the study for?

This trial is for people aged 65-80 who are at risk of Alzheimer's but don't yet have it. Participants must be able to get an MRI and do cognitive tests, not be in another study, and have a family history of Alzheimer's or early signs of amyloid and tau pathology.

What is being tested?

The trial is testing Donanemab against a placebo to see if it can prevent the onset of Alzheimer's Disease in individuals who show early signs but do not yet have symptoms. The safety and effectiveness will be evaluated.

What are the potential side effects?

While specific side effects for Donanemab aren't listed here, similar drugs may cause reactions at the injection site, flu-like symptoms, headache, dizziness, nausea or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I do not have Alzheimer's or dementia.

Select...

You can only participate in this study if you are not already taking part in another research study.

Select...

I am between 65 and 80 years old.

Select...

I am willing and able to have an MRI scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, up to week 182

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, up to week 182

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to week 182 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Nootropic Agents

Secondary study objectives

Change from Baseline in Behavioral Pattern Separation-Object test (BPS-O)

Change from Baseline in CDR-Sum of Boxes (CDR-SB)

Change from Baseline in Category Fluency

+9 more

Side effects data

From 2023 Phase 3 trial • 148 Patients • NCT05108922

33%

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

Fall

Nausea

Fatigue

Diarrhoea

Benign prostatic hyperplasia

Back pain

Cataract

Dizziness

Infusion site extravasation

Upper respiratory tract infection

Tooth infection

Nasopharyngitis

Hypertensive urgency

Infusion related reaction

Gastroenteritis

Rotator cuff syndrome

Coronary artery disease

Muscle spasms

Sinusitis

Arthralgia

Chest pain

Rash

Oedema peripheral

Muscular weakness

Hypertension

Urinary tract infection

Sars-cov-2 test positive

Bronchitis

Ageusia

Lacunar infarction

Osteoarthritis

Hyperlipidaemia

Lymphocytosis

Toothache

Non-cardiac chest pain

Neck pain

Gastritis

Ocular procedural complication

Muscle discomfort

Asthenia

Thrombocytopenia

Hyperbilirubinaemia

Cough

Spinal compression fracture

Infusion site reaction

Pain

Hyperglycaemia

Rash erythematous

Gait disturbance

Hypervolaemia

Transient ischaemic attack

Epiretinal membrane peel

Iron deficiency anaemia

Leukocytosis

Lymphopenia

Atrial fibrillation

Cardiomegaly

Tinnitus

Visual field defect

Eructation

Gastric polyps

Gingival swelling

Inguinal hernia

Parotid duct obstruction

Conjunctivitis

Gastroenteritis viral

Influenza

Lower respiratory tract infection

Viral infection

Arthropod bite

Facial bones fracture

Pelvic fracture

Shoulder fracture

Skin abrasion

Blood cholesterol increased

Hepatic enzyme increased

Weight decreased

Hypomagnesaemia

Ejection fraction decreased

Hepatic enzyme abnormal

Hyponatraemia

Groin pain

Intervertebral disc protrusion

Joint swelling

Myalgia

Scoliosis

Basal cell carcinoma

Osteoma

Cerebral haemorrhage

Migraine

Neuropathy peripheral

Paraesthesia

Somnolence

Agitation

Confusional state

Depression

Initial insomnia

Mood altered

Nocturia

Pollakiuria

Urinary retention

Pulmonary mass

Dermatitis

Hyperkeratosis

Aortic aneurysm

Peripheral arterial occlusive disease

Syncope

Cholecystitis

Gastrooesophageal reflux disease

Peripheral artery aneurysm

Vomiting

Cerebral microhaemorrhage

Nerve compression

Anxiety

Depressed mood

Pain in extremity

Benign tumour excision

Atrioventricular block second degree

Anaemia

Haemarthrosis

Fibromyalgia

Bradycardia

Dysphagia

Obstructive sleep apnoea syndrome

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.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DonanemabExperimental Treatment1 Intervention

Donanemab administered intravenously (IV)

Group II: PlaceboPlacebo Group1 Intervention

Placebo is administered intravenously

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Donanemab

2017

Completed Phase 3

~500

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 (AD) often target amyloid-beta (Aβ) plaques, which are believed to play a critical role in the disease's progression. Donanemab, for example, is an antibody that specifically targets and helps clear Aβ plaques from the brain. This mechanism is crucial because the accumulation of these plaques is associated with neuronal damage and cognitive decline in AD patients. By reducing plaque buildup, treatments like Donanemab aim to slow disease progression and preserve cognitive function. Other treatments may focus on neurotransmitter regulation, such as cholinesterase inhibitors, which increase acetylcholine levels to improve communication between nerve cells. Understanding these mechanisms helps in developing targeted therapies that can more effectively manage or potentially alter the course of Alzheimer's Disease.

Lessons Learnt from the Second Generation of Anti-Amyloid Monoclonal Antibodies Clinical Trials.