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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 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).

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.

Find a Location

Who is running the clinical trial?

EIP Pharma IncLead Sponsor
5 Previous Clinical Trials
299 Total Patients Enrolled
1 Trials studying Dementia
91 Patients Enrolled for Dementia
Worldwide Clinical TrialsOTHER
63 Previous Clinical Trials
14,605 Total Patients Enrolled
2 Trials studying Dementia
190 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,761 Previous Clinical Trials
28,183,793 Total Patients Enrolled
286 Trials studying Dementia
23,632,863 Patients Enrolled for Dementia

Media Library

Neflamapimod (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05869669 — Phase 2
Dementia Research Study Groups: Neflamapimod, Placebo
Dementia Clinical Trial 2023: Neflamapimod Highlights & Side Effects. Trial Name: NCT05869669 — Phase 2
Neflamapimod (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05869669 — Phase 2
~66 spots leftby Oct 2025