What side effects are associated with this type of intervention?

Common treatments for dementia, such as donepezil and memantine, have known side effects. Donepezil can cause gastrointestinal issues, insomnia, muscle cramps, and fatigue. Memantine may lead to dizziness, headache, confusion, and constipation. Aducanumab, another treatment, has been associated with amyloid-related imaging abnormalities (ARIA), headache, falls, diarrhea, and confusion. These side effects highlight the importance of monitoring and managing adverse reactions in dementia treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for dementia, primarily focusing on Alzheimer's disease. These include cholinesterase inhibitors like donepezil, rivastigmine, and galantamine, which work by increasing levels of acetylcholine in the brain, and memantine, an NMDA receptor antagonist that regulates glutamate activity. Recently, aducanumab, an anti-amyloid monoclonal antibody, received FDA approval for Alzheimer's, targeting amyloid plaques in the brain. While neflamapimod, a p38 MAP kinase inhibitor, is still under investigation, it represents a novel approach aimed at reversing synaptic dysfunction and slowing disease progression, distinct from the mechanisms of currently approved treatments.

What other types of research exist?

Promising novel alternatives to Neflamapimod for dementia treatment in 2024 include: 1) SM07883, a potent, selective oral DYRK1A inhibitor, which has shown potential in reducing tau pathology and neuroinflammation in Alzheimer's disease models. 2) Brain-penetrant microtubule-stabilizing compounds, which are being explored for their therapeutic effects in tauopathies. These alternatives target different aspects of dementia pathology and have shown encouraging results in preclinical and early clinical studies.

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Kinase Inhibitor

Neflamapimod for Lewy Body Dementia

Verified Trial

Phase 2

Recruiting

Research Sponsored by EIP Pharma Inc

Eligibility Criteria Checklist

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

Must have

Normal or corrected eyesight and auditory abilities, sufficient to perform all aspects of the cognitive and functional assessments

Be older than 18 years old

Must not have

Diagnosis of any other ongoing central nervous system (CNS) condition other than DLB, including, but not limited to, post-stroke dementia, vascular dementia, Alzheimer's disease (AD), or Parkinson's disease (PD)

Poorly controlled clinically significant medical illness, such as hypertension (blood pressure >180 mmHg systolic or 100 mmHg diastolic); myocardial infarction within 6 months; uncompensated congestive heart failure or other significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would interfere with assessment of drug safety

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Summary

This trial is testing neflamapimod, a drug that may help improve thinking and memory skills. It targets people with Dementia with Lewy Bodies (DLB), who often struggle with these issues. The drug works by reducing inflammation in the brain.

Who is the study for?

This trial is for individuals aged ≥55 with Dementia with Lewy Bodies (DLB), who have received a positive DaTscan™ or have REM sleep behavioral disorder, and are on stable cholinesterase inhibitor therapy. They must be vaccinated against COVID-19, not suffer from other CNS conditions like Alzheimer's or Parkinson's, and should not have major psychiatric disorders or recent drug abuse history.

What is being tested?

The study tests if Neflamapimod can improve cognitive functions such as verbal learning, memory, and attention in DLB patients compared to a placebo. Participants will initially receive either the drug or placebo for 16 weeks; afterwards, all participants may receive Neflamapimod for an additional 32 weeks.

What are the potential side effects?

While specific side effects of Neflamapimod aren't listed here, common side effects in dementia trials include gastrointestinal issues (nausea, diarrhea), headaches, dizziness, and potential allergic reactions. The severity varies among individuals.

Eligibility Criteria

Inclusion Criteria

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

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My vision and hearing are good enough for tests.

Exclusion Criteria

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

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I do not have any ongoing brain conditions other than DLB.

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I do not have any severe health issues that could affect the safety assessment of the drug.

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I am a man and will not or cannot follow the study's birth control rules.

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I weigh less than 60kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 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

Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in neflamapimod-treated subjects compared to placebo recipients.

Secondary study objectives

Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-GCIC) score at Week 16 in neflamapimod-treated subjects compared to placebo recipients.

Change in Timed Up and Go Test (TUG) in neflamapimod-treated subjects compared to placebo recipients.

Change in the composite score of the Neuropsychological Test Battery (NTB), including tests of attention, executive function, and visual learning in neflamapimod-treated subjects compared to placebo recipients.

Other study objectives

Exploratory outcome - 12-item Neuropsychiatric Inventory (NPI-12)

Exploratory outcome - Dementia Cognitive Fluctuations Scale (DCFS)

Exploratory outcome - EEG

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: NeflamapimodActive Control1 Intervention

Neflamapimod will be administered with food for 16 weeks in subjects with DLB. Subjects will receive 3 capsules per day (TID) with food (i.e., with the morning, mid-day and evening meals).

Group II: PlaceboPlacebo Group1 Intervention

Placebo will be administered with food for 16 weeks in subjects with DLB. Subjects will receive 3 capsules per day (TID) with food (i.e., with the morning, mid-day and evening meals).

0 / 5Eligibility 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 dementia include cholinesterase inhibitors (e.g., donepezil, rivastigmine) which work by increasing levels of acetylcholine in the brain, and NMDA receptor antagonists (e.g., memantine) which regulate glutamate activity to prevent excitotoxicity. Neflamapimod, a p38 MAP kinase inhibitor, targets inflammation and neuronal signaling pathways, potentially reducing neurodegeneration. These mechanisms are crucial as they aim to slow cognitive decline, manage symptoms, and improve quality of life for dementia patients by addressing different pathological aspects of the disease.

The Efficacy and Safety of Alzheimer's Disease Therapies: An Updated Umbrella Review.Pathological mechanisms and therapeutic strategies for Alzheimer's disease.Recent advances in the management of neuropsychiatric symptoms in dementia.