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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Study Summary
This trial is testing if a drug can improve learning, problem solving, and memory in people with dementia with Lewy Bodies.
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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in neflamapimod-treated subjects compared to placebo recipients.
Secondary outcome measures
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 outcome measures
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).
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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
61 Previous Clinical Trials
14,227 Total Patients Enrolled
2 Trials studying Dementia
190 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,903 Total Patients Enrolled
266 Trials studying Dementia
23,625,200 Patients Enrolled for Dementia
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible to enroll in this scientific investigation at present?
"That is correct. According to clinicaltrials.gov, this medical trial was originally posted on May 1st 2023 and remains open for recruitment as of the 17th of May in the same year. Presently, 160 patients need to be recruited from only a single site."
Answered by AI
How many individuals are currently enrolled in the trial?
"Affirmative. Clinicaltrials.gov affirms that this clinical trial is still seeking participants; the study was first posted on May 1st 2023 and subsequently edited on the 17th of the same month. The goal is to recruit 160 individuals from a single medical site."
Answered by AI
Has Neflamapimod been sanctioned for medical use by the FDA?
"Our team has given Neflamapimod a score of 2 as the Phase 2 trial provides some proof that it is safe but does not provide any evidence that it is efficacious."
Answered by AI
Who else is applying?
What site did they apply to?
University of North Carolina - Dept of Neurology
Mass General Hospital/Harvard Medical School - Dept of Neurology
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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