What side effects are associated with this type of intervention?

Common treatments for Neurocognitive Disorder, particularly anti-amyloid plaque therapies like Donanemab, often include side effects such as Amyloid-Related Imaging Abnormalities (ARIA), which can manifest as ARIA-E (edema) or ARIA-H (hemorrhage). These side effects can vary in severity, with some patients experiencing headaches, confusion, dizziness, nausea, and in severe cases, seizures. Other treatments, such as cholinesterase inhibitors (e.g., donepezil, rivastigmine, galantamine), may cause gastrointestinal issues like nausea, vomiting, and diarrhea, as well as muscle cramps, fatigue, and insomnia. Memantine, another common treatment, can lead to dizziness, headache, confusion, and constipation.

What prior FDA approvals exist?

The FDA has approved several treatments for neurocognitive disorders, particularly Alzheimer's disease, that target amyloid plaques. Notable among these is Aducanumab (Aduhelm), an anti-amyloid monoclonal antibody that reduces amyloid-beta plaques in the brain. Another similar treatment is Lecanemab, which also targets amyloid-beta to slow disease progression. These drugs are part of a broader category of anti-amyloid therapies aimed at modifying the underlying pathology of Alzheimer's disease, similar to the investigational drug Donanemab.

What other types of research exist?

Promising alternatives to Donanemab for treating neurocognitive disorders include: 1) Aducanumab, which targets Aβ oligomers and plaques, 2) Solanezumab, which targets Aβ monomers, 3) Crenezumab, which targets Aβ oligomers, and 4) Gantenerumab, which targets Aβ fibrils. These therapies are in various stages of clinical trials and have shown potential in targeting amyloid plaques in Alzheimer's disease.

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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing different doses of donanemab, a drug aimed at helping people with early Alzheimer's disease. Donanemab has shown rapid reduction of brain amyloid in early Alzheimer's disease. The study will look at how often and how severely participants experience a side effect involving brain swelling. Researchers also want to find out which patient characteristics might predict this side effect.

Who is the study for?

This trial is for adults with early symptomatic Alzheimer's who have had memory issues for over 6 months, confirmed amyloid pathology in the brain, and a certain score on a mental state exam. People with serious illnesses, cancer within the last 5 years, life expectancy under 2 years, or significant neurological diseases other than Alzheimer's can't join.

What is being tested?

The study tests different doses of Donanemab to see how they affect brain swelling (ARIA-E) in people with early Alzheimer's. It also looks at whether certain characteristics predict ARIA risk. Participants will either receive Donanemab or a placebo.

What are the potential side effects?

Donanemab may cause side effects like brain swelling (ARIA-E), which includes symptoms such as headaches, confusion, dizziness, vision changes, and nausea. The severity of these side effects varies among individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Donanemab Dose Level 4Experimental Treatment2 Interventions

Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind.

Group II: Donanemab Dose Level 3Experimental Treatment2 Interventions

Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind.

Group III: Donanemab Dose Level 2Experimental Treatment2 Interventions

Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind.

Group IV: Donanemab Dose Level 1Experimental Treatment2 Interventions

Participants will receive donanemab by intravenously (IV) infusion. Participants will receive placebo at certain intervals to preserve the blind.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Donanemab

2017

Completed Phase 3

~500

Placebo

1995

Completed Phase 3

~2670

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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 Neurocognitive Disorder include cholinesterase inhibitors, NMDA receptor antagonists, and anti-amyloid plaque therapies. Cholinesterase inhibitors, such as donepezil, work by preventing the breakdown of acetylcholine, a neurotransmitter important for memory and learning, thereby improving cognitive function. NMDA receptor antagonists, like memantine, regulate glutamate activity to prevent excitotoxicity, which can damage neurons. Anti-amyloid plaque therapies, such as Donanemab, target and remove amyloid-beta plaques in the brain, which are believed to contribute to the progression of Alzheimer's disease. These treatments are crucial as they address different pathological aspects of Neurocognitive Disorder, potentially slowing disease progression and improving quality of life for patients.

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