What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease, particularly those targeting amyloid plaques like ABBV-916, often have side effects such as amyloid-related imaging abnormalities (ARIA), which can include brain swelling and microhemorrhages. Other side effects may include headache, falls, diarrhea, confusion, and hypersensitivity reactions like angioedema and urticaria. Cholinesterase inhibitors, another class of drugs used in Alzheimer's treatment, can cause nausea, vomiting, and worsened tremors. Memantine, used for moderate to severe Alzheimer's, may lead to dizziness, headache, confusion, and constipation.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease, primarily focusing on symptom management and slowing disease progression. Notably, aducanumab (Aduhelm) was approved for its ability to reduce amyloid plaques in the brain, similar to the investigational drug ABBV-916. Other treatments include cholinesterase inhibitors like donepezil (Aricept) and NMDA receptor antagonists like memantine (Namenda), which help manage cognitive symptoms but do not target amyloid plaques directly.

What other types of research exist?

Promising novel alternatives to ABBV-916 for treating Alzheimer's Disease in 2024 include: 1) Lecanemab, an anti-amyloid beta protofibril antibody that has shown promise in reducing amyloid plaques and slowing cognitive decline. 2) Donanemab, an antibody targeting a modified form of amyloid-beta, which has demonstrated potential in clearing amyloid plaques and improving clinical outcomes. 3) Aducanumab, an anti-amyloid beta monoclonal antibody, which has been approved by the FDA and is being further studied for its long-term efficacy and safety. 4) ALZ-801, an oral agent that inhibits amyloid formation and is being evaluated for its effects on cognitive function and amyloid levels. These alternatives are in various stages of clinical development and may offer new hope for AD patients.

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ABBV-916 for Early Alzheimer's Disease

Verified Trial

Phase 2

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Stage 3 or Stage 4 Alzheimer's disease (AD) based on the 2018 National Institute on Aging (NIA)-Alzheimer's Association (AA) Research Framework Criteria

Mini-Mental State Examination (MMSE) score of 20 to 28, inclusive, at Screening

Timeline

Screening 3 days

Treatment Varies

Follow Up up to approximately 160 weeks

Summary

This trial is testing a new drug called ABBV-916 to see if it can help people aged 50-90 who are in the early stages of Alzheimer's disease. Participants will receive the drug regularly over several months. The study aims to find out if the drug is safe and effective by monitoring changes in symptoms and side effects.

Who is the study for?

This trial is for adults aged 50-90 with early Alzheimer's Disease, who score between 20 to 28 on the MMSE and have amyloid pathology confirmed by PET scans or blood tests. They must be at Stage 3 or Stage 4 of AD as per NIA-AA criteria and have a study partner available for at least 10 hours weekly. Excluded are those with significant brain MRI findings, more than three microhemorrhages, any macrohemorrhages, severe white matter disease, or on anticoagulant therapy.

What is being tested?

The safety and effectiveness of ABBV-916 in treating early Alzheimer's are being tested against a placebo. Participants will receive IV doses every four weeks for six months followed by an extension period where all get ABBV-916. The first part is double-blind; neither doctors nor participants know who gets what until later stages.

What are the potential side effects?

Potential side effects may include reactions to IV treatment, changes in brain function due to medication interactions with amyloid plaques, and general adverse events typically monitored through medical assessments including MRIs and blood tests.

Eligibility Criteria

Inclusion Criteria

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

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My condition is diagnosed as Stage 3 or 4 Alzheimer's disease.

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Your Mini-Mental State Examination (MMSE) score at screening must be between 20 and 28.

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Your blood test shows a high chance of having abnormal protein levels related to Alzheimer's disease, unless you have had a brain scan showing the same thing in the past.

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Your brain scan shows signs of amyloid buildup.

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I have someone who can be with me for at least 10 hours a week.

Timeline

Screening ~ 3 days1 visit

Treatment ~ Varies

Follow Up ~ up to approximately 160 weeks

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~up to approximately 160 weeks

This trial's timeline: 3 days for screening, Varies for treatment, and up to approximately 160 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants Experiencing Adverse Events (AEs)

Stage A: Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-916

Stage A: Area Under the Concentration-Time Curve (AUC) of ABBV-916

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Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Stage B: ABBV-916 Dose BExperimental Treatment1 Intervention

Participants will receive ABBV-916 Dose B for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.

Group II: Stage B: ABBV-916 Dose AExperimental Treatment1 Intervention

Participants will receive ABBV-916 Dose A for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.

Group III: Stage A: ABBV-916Experimental Treatment1 Intervention

Participants will receive ABBV-916 for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.

Group IV: Stage A: Placebo for ABBV-916Placebo Group1 Intervention

Participants will receive Placebo for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.

Group V: Stage B: Placebo for ABBV-916Placebo Group1 Intervention

Participants will receive Placebo for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.

0 / 6Eligibility 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 plaques and neurotransmitter systems. ABBV-916, an investigational drug, aims to clear amyloid plaques from the brain, which are believed to contribute to the neurodegenerative process in AD. Other treatments, such as cholinesterase inhibitors (e.g., donepezil, rivastigmine) and NMDA receptor antagonists (e.g., memantine), work by enhancing neurotransmitter function to improve cognitive symptoms. These mechanisms are crucial as they address the underlying pathology and symptomatic relief, potentially slowing disease progression and improving quality of life for AD patients.