What side effects are associated with this type of intervention?

The most common treatments for Alzheimer's Disease include cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and memantine. Cholinesterase inhibitors can cause side effects such as nausea, vomiting, diarrhea, muscle cramps, and loss of appetite. Memantine, which is often used in moderate to severe cases, may cause dizziness, headache, confusion, and constipation. While specific side effects for Sigma-1 Receptor Agonists like ANAVEX2-73 are not detailed, it is important to monitor for similar adverse effects and discuss them with a healthcare provider.

What prior FDA approvals exist?

FDA-approved treatments for Alzheimer's Disease primarily include cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and the NMDA receptor antagonist memantine. These drugs aim to improve cognitive function and slow disease progression. While ANAVEX2-73, a Sigma-1 Receptor Agonist, is still under investigation, it represents a novel approach compared to the existing treatments that focus on cholinergic and glutamatergic systems.

What other types of research exist?

Promising novel alternatives to ANAVEX2-73 for Alzheimer's Disease patients in 2024 include: 1) Lecanemab, an anti-amyloid beta monoclonal antibody, which has shown efficacy in reducing amyloid plaques and slowing cognitive decline. 2) Donanemab, another anti-amyloid beta antibody, targeting a different epitope of amyloid plaques. 3) Tau-targeting therapies like semorinemab, which aim to reduce tau pathology. 4) Alpha7 nicotinic acetylcholine receptor agonists such as SEN12333, which have shown procognitive and neuroprotective properties. 5) Anti-inflammatory agents targeting neuroinflammation, such as ALZT-OP1. These alternatives represent diverse mechanisms of action and are in various stages of clinical development.

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ANAVEX2-73 for Alzheimer's Disease (ATTENTION-AD Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by Anavex Life Sciences Corp.

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 96 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called ANAVEX2-73 to see if it is safe and effective. It targets patients who may need new or better treatment options. The study aims to find out if taking this medication regularly can help improve their condition.

Who is the study for?

This trial is for those who completed the ANAVEX2-73-AD-004 study, can be outpatients or in assisted living, and have a partner to help with assessments. They must not have severe suicidal thoughts or behaviors recently and women of childbearing age must not be pregnant.

What is being tested?

The trial tests the long-term safety and effectiveness of ANAVEX2-73 when taken daily by people with Alzheimer's Disease who participated in a prior related study.

What are the potential side effects?

Specific side effects are not listed here, but participants from the previous study cannot join if they had moderate to severe adverse events possibly related to ANAVEX2-73 that haven't resolved.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 96 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~96 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 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 with treatment-related adverse events as assessed by CTCAE v4.03

Secondary study objectives

ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition)

ADCS-ADL (Activities of Daily Living)

Awards & Highlights

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: ActiveExperimental Treatment1 Intervention

ANAVEX2-73

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ANAVEX2-73

2019

Completed Phase 3

~520

Do I qualify?Apply below to find out

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) include cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and memantine. Cholinesterase inhibitors work by inhibiting the enzyme cholinesterase, which breaks down acetylcholine, thereby increasing the levels of acetylcholine in the brain. This is important because acetylcholine is a neurotransmitter associated with memory and learning, and its levels are typically reduced in AD patients. Memantine, on the other hand, is an NMDA receptor antagonist that helps regulate glutamate activity, preventing excitotoxicity that can lead to neuronal damage. ANAVEX2-73, a Sigma-1 receptor agonist, is being studied for its potential neuroprotective effects, which may help in modulating cellular stress and improving cognitive function. These treatments are crucial as they aim to alleviate symptoms and potentially slow the progression of AD, thereby improving the quality of life for patients.