Your session is about to expire
← Back to Search
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 belowSelect...
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:Select...
I do not have any ongoing brain conditions other than DLB.
Select...
I do not have any severe health issues that could affect the safety assessment of the drug.
Select...
I am a man and will not or cannot follow the study's birth control rules.
Select...
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
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 moreTrial 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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can continue in the study for an extra 8 months after the first 16 weeks.Your liver enzymes (AST or ALT) are more than double the normal level, your bilirubin level is higher than 1.5 times the normal level, and/or your blood clotting time is prolonged.You have HIV, hepatitis B, or active hepatitis C infection.Your CDR Global Score is 0.5 or 1.0 during the screening.You have been diagnosed with alcohol or drug abuse in the past 2 years.I do not have any severe health issues that could affect the safety assessment of the drug.I do not have any ongoing brain conditions other than DLB.Your blood test shows ptau181 level higher than 2.4 pg/mL, which is linked to Alzheimer's disease.I have had brain surgery in the last 5 years.You have had thoughts of harming yourself in the past 6 months, attempted suicide in the past 2 years, or are considered to be at risk of harming yourself by the doctor.I weigh less than 60kg.My vision and hearing are good enough for tests.I am a man and will not or cannot follow the study's birth control rules.I am a woman who can still have children and agree to follow the study's birth control rules.I am 55 years old or older.I have been diagnosed with DLB and am on cholinesterase inhibitors, or I have RBD confirmed by a sleep study.I have been on a stable dose of cholinesterase inhibitor for over 6 weeks, or I stopped it more than 3 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: Neflamapimod
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger