What is the mechanism of action of this treatment?

Common treatments for Alzheimer's Disease (AD) primarily include cholinesterase inhibitors (donepezil, rivastigmine, galantamine), which work by increasing cholinergic transmission to provide modest symptomatic relief in cognition and global functioning. Aducanumab, a monoclonal antibody, targets amyloid-beta plaques to potentially slow disease progression, though its clinical benefits are still under scrutiny. Vitamin E, an antioxidant, may offer modest benefits in delaying functional decline. These treatments are crucial as they aim to manage symptoms and potentially alter disease progression. Similar to these treatments, Senicapoc is being studied for its ability to reduce neuroinflammation by inhibiting KCa3.1 potassium channels, which could offer a novel approach to modifying disease mechanisms in AD.

What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease (AD) that target neuroinflammation, such as anti-inflammatory drugs, have been investigated but often come with significant side effects. For example, aducanumab, an amyloid-targeting antibody, has been associated with amyloid-related imaging abnormalities (ARIA), including brain swelling and microhemorrhages, as well as headaches, falls, diarrhea, and confusion. Antioxidants like vitamin E are generally well-tolerated but offer only modest benefits. Hormone replacement therapy (HRT) with estrogen has been linked to an increased risk of dementia and other adverse effects. Overall, while these treatments aim to modify disease progression, their side effects and efficacy vary, necessitating careful consideration and monitoring.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease, primarily focusing on symptom management rather than disease modification. Notable drugs include cholinesterase inhibitors like donepezil, rivastigmine, and galantamine, which help increase levels of acetylcholine in the brain, and memantine, an NMDA receptor antagonist that regulates glutamate activity. Recently, aducanumab, a monoclonal antibody targeting amyloid-beta plaques, was approved, marking a shift towards disease-modifying therapies. While specific treatments targeting neuroinflammation through KCa3.1 potassium channel inhibition like Senicapoc are not yet approved, the focus on reducing neuroinflammation is a promising area of ongoing research.

What other types of research exist?

Promising novel alternatives to Senicapoc for Alzheimer's Disease treatment in 2024 include: 1) Anti-amyloid antibodies such as aducanumab and lecanemab, which target amyloid-beta plaques. 2) Tau aggregation inhibitors like semorinemab, which aim to prevent tau protein tangles. 3) Anti-inflammatory agents such as ALZT-OP1, which target neuroinflammation. 4) Gene therapy approaches like CRISPR-Cas9 targeting amyloid precursor protein (APP) mutations. These therapies are in various stages of clinical trials and show potential in addressing different aspects of AD pathology.

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Ion Channel Blocker

Senicapoc for Alzheimer's Disease (Senicapoc Trial)

Phase 2

Recruiting

Led By John Olichney, MD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

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

Must have

Age 55-85

Consensus clinical diagnosis of either amnestic Mild Cognitive Impairment (MCI) or mild AD dementia

Must not have

Requires daily antiplatelet therapy

On anticoagulant therapy (within 14 days of lumbar puncture (LP))

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 26, week 52

Summary

This trial tests Senicapoc, a drug that may reduce brain inflammation, in patients with early-stage Alzheimer's disease. The goal is to see if it can slow down memory loss and other symptoms by protecting brain cells.

Who is the study for?

This trial is for people aged 55-85 with early Alzheimer's or mild cognitive impairment, fluent in English/Spanish, and have a study partner. Women must use contraception if of childbearing potential. Exclusions include pregnancy, difficulty swallowing pills, recent high radiation exposure, inability to undergo MRI scans, unstable medical conditions like severe heart failure or renal insufficiency, psychiatric illness history including major depression within the last two years.

What is being tested?

The trial tests Senicapoc against a placebo in patients with mild Alzheimer's over one year. It aims to see if Senicapoc can improve cognition and reduce neuroinflammation by measuring changes in ADAS-Cog scores and inflammatory markers in blood/CSF.

What are the potential side effects?

While specific side effects are not listed here for Senicapoc as it is under investigation, common drug-related side effects could include gastrointestinal issues (nausea/vomiting), headaches, dizziness or allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am between 55 and 85 years old.

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I have been diagnosed with early memory loss or mild Alzheimer's disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I take daily medication to prevent blood clots.

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I have been on blood thinner medication within 2 weeks of a spinal tap.

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I regularly use medications for my brain or mood.

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I have had a serious brain infection or head injury that affects my thinking.

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I do not have severe heart issues, breathing problems, unstable blood conditions, or a life expectancy under 3 years.

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I do not have unstable liver, kidney issues, or severely reduced kidney function.

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I have a history of bleeding disorders.

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I am not using any experimental Alzheimer's treatments.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the trial.

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I cannot swallow pills.

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I have been exposed to more than 2 rem of radiation in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 26, week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 26, week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 26, week 52 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Alzheimer's Disease

Cerebrospinal fluid shunts procedure

Change from Baseline to Week 52 in levels of serum biomarkers: IL-6, TNF-α, MCP-1, and IL-10 and high sensitivity C-Reactive protein

Secondary study objectives

Change from Baseline in Bushcke Cued Selective Reminding Task (CSRT) score

Change from Baseline in Cognitive Event Related Potential (ERP) measures of P600 word repetition.

Change from Baseline in Cognitive Event Related Potential (ERP) measures of alpha suppression effect.

+13 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 10 mg daily SenicapocExperimental Treatment1 Intervention

10 mg daily Senicapoc for 52 weeks

Group II: Placebo GroupPlacebo Group1 Intervention

Placebo daily for 52 weeks

0 / 13Eligibility 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) primarily include cholinesterase inhibitors (donepezil, rivastigmine, galantamine), which work by increasing cholinergic transmission to provide modest symptomatic relief in cognition and global functioning. Aducanumab, a monoclonal antibody, targets amyloid-beta plaques to potentially slow disease progression, though its clinical benefits are still under scrutiny. Vitamin E, an antioxidant, may offer modest benefits in delaying functional decline. These treatments are crucial as they aim to manage symptoms and potentially alter disease progression. Similar to these treatments, Senicapoc is being studied for its ability to reduce neuroinflammation by inhibiting KCa3.1 potassium channels, which could offer a novel approach to modifying disease mechanisms in AD.