What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease, such as cholinesterase inhibitors (donepezil, rivastigmine) and memantine, have known side effects. Cholinesterase inhibitors can cause gastrointestinal issues (nausea, vomiting, diarrhea), muscle cramps, fatigue, and insomnia. Memantine may lead to dizziness, headache, confusion, and constipation. Investigational drugs like ABBV-552, while still under study, may have side effects similar to those observed in clinical trials for other Alzheimer's treatments, including headache, falls, diarrhea, and confusion. It's important to monitor for these side effects and discuss them with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Alzheimer's Disease, primarily focusing on symptom management and slowing disease progression. Cholinesterase inhibitors like donepezil and galantamine are commonly used to improve cognitive function by increasing acetylcholine levels in the brain. Memantine, an NMDA receptor antagonist, is another approved drug that helps manage symptoms by regulating glutamate activity. These treatments share a common goal with ABBV-552, which is also aimed at alleviating cognitive symptoms in Alzheimer's patients. While ABBV-552 is still investigational, it represents a continued effort to find effective therapies for this debilitating condition.

What other types of research exist?

Promising novel alternatives to ABBV-552 for Alzheimer's Disease patients include: 1) Lecanemab, an anti-amyloid beta protofibril antibody that has shown positive results in reducing cognitive decline. 2) Donanemab, another anti-amyloid antibody targeting a modified form of beta-amyloid. 3) Aducanumab, an anti-amyloid beta monoclonal antibody approved by the FDA, though its use is still under scrutiny. 4) ALZ-801, an oral agent targeting amyloid beta oligomers. These alternatives are in various stages of clinical trials and have shown potential in modifying disease progression.

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Oral ABBV-552 for Alzheimer's Disease (Abroad Trial)

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 probable Alzheimer's disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) (2011) criteria.

* Mini-Mental State Examination (MMSE) score of 20 to 26, a Clinical Dementia Rating (CDR) global score of 0.5 or 1.0, with a CDR memory score of 0.5 or higher, and at least 1 CDR functional domain (community affairs, home and hobbies, or personal care) score of 0.5 or higher at Screening Visit 1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (week 0) through week 12

Summary

This trial tests a new drug called ABBV-552 to see if it can help people aged 50-90 with early Alzheimer's disease. Participants will take the drug daily for a few months, and researchers will check its effects on memory and other symptoms.

Who is the study for?

This trial is for people aged 50 to 90 with mild Alzheimer's Disease, as defined by specific criteria including certain scores on memory and cognitive tests. Those with significant unstable medical conditions or factors that may affect study participation are excluded.

What is being tested?

The trial is testing ABBV-552, a new drug for early Alzheimer's symptoms. Participants will be randomly assigned to one of four groups, three receiving different doses of the drug and one receiving a placebo, over a period of 12 weeks.

What are the potential side effects?

Potential side effects include reactions related to the nervous system changes due to Alzheimer’s treatment but specifics aren't provided. Regular check-ups will monitor any adverse events from taking ABBV-552.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week 0) through week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (week 0) through week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) through week 12 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 in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) score

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: ABBV-552 Dose CExperimental Treatment1 Intervention

Participants will receive ABBV-552 Dose C QD for 12 weeks.

Group II: ABBV-552 Dose BExperimental Treatment1 Intervention

Participants will receive ABBV-552 Dose B QD for 12 weeks.

Group III: ABBV-552 Dose AExperimental Treatment1 Intervention

Participants will receive ABBV-552 Dose A once daily (QD) for 12 weeks.

Group IV: Placebo for ABBV-552Placebo Group1 Intervention

Participants will receive placebo for ABBV-552 QD for 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ABBV-552

2023

Completed Phase 2

~290

0 / 2Eligibility 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

Common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors and NMDA receptor antagonists. Cholinesterase inhibitors, such as donepezil, enhance cholinergic function by preventing the breakdown of acetylcholine, a neurotransmitter essential for memory and learning. NMDA receptor antagonists, like memantine, regulate glutamate activity to prevent neuronal damage from excitotoxicity. Investigational drugs like ABBV-552 may target similar or novel pathways to improve cognitive function. These mechanisms are vital for AD patients as they help manage symptoms, slow disease progression, and enhance quality of life.