Neflamapimod for Lewy Body Dementia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether neflamapimod can improve learning, problem-solving, and memory in individuals with Lewy Body Dementia (DLB), a condition affecting thinking and movement. Participants will receive either neflamapimod or a placebo (a harmless, inactive substance) for 16 weeks to assess improvements in memory and attention. Suitable candidates for this trial have DLB, experience symptoms like visual hallucinations or sleep disturbances, and are not currently on certain dementia medications. After the initial 16 weeks, all participants can continue taking neflamapimod for an additional 8 months. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important advancements in DLB treatment.
Will I have to stop taking my current medications?
The trial requires that you are not currently taking cholinesterase inhibitors unless you have been on a stable dose for at least 6 weeks. If you previously took cholinesterase inhibitors, you must have stopped at least 3 months before joining. Memantine is allowed if started at least 3 months prior and you are also on cholinesterase inhibitors, or as monotherapy if you have never taken cholinesterase inhibitors.
Is there any evidence suggesting that neflamapimod is likely to be safe for humans?
Research shows that neflamapimod, the treatment under study, is generally well-tolerated by patients. In a previous study with individuals who have dementia with Lewy bodies (DLB), neflamapimod improved thinking abilities, and no major safety issues emerged. The study examined patient reactions to the drug over several weeks, and results suggested it was safe to use.
Neflamapimod has also advanced in clinical research, indicating it has passed earlier safety tests. Like any medication, minor side effects may occur, but no serious problems have been reported in the research so far.
Overall, current evidence supports that neflamapimod is safe for people, especially since earlier studies have carefully tested it.12345Why do researchers think this study treatment might be promising for Lewy Body Dementia?
Most treatments for Lewy Body Dementia focus on managing symptoms using drugs like cholinesterase inhibitors or antipsychotics. But Neflamapimod works differently, targeting the underlying disease mechanisms by inhibiting an enzyme called p38 MAP kinase. This enzyme is associated with inflammation and nerve cell dysfunction, which are key factors in Lewy Body Dementia. Researchers are excited because this approach could potentially slow down disease progression, offering more than just symptom relief.
What evidence suggests that neflamapimod might be an effective treatment for Lewy Body Dementia?
Research has shown that neflamapimod, which participants in this trial may receive, may help slow memory and thinking problems in people with Lewy Body Dementia (DLB). In some studies, patients taking neflamapimod performed better on memory and thinking tests compared to those who took a placebo, a pill with no active medicine. Specifically, improvements appeared in tests measuring dementia severity. Neflamapimod also improved patients' movement, potentially making daily activities easier. Early results from other research suggest it could positively affect brain health markers. Overall, these findings offer hope that neflamapimod could effectively treat DLB.12346
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive neflamapimod or placebo for 16 weeks to assess improvements in cognitive and motor functions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Neflamapimod
Find a Clinic Near You
Who Is Running the Clinical Trial?
EIP Pharma Inc
Lead Sponsor
Worldwide Clinical Trials
Collaborator
National Institute on Aging (NIA)
Collaborator
CervoMed, Inc
Collaborator