Neflamapimod for Lewy Body Dementia

Recruiting at 46 trial locations

Overseen By Aaron Ritter, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: EIP Pharma Inc

Must be taking: Cholinesterase inhibitors

Disqualifiers: Alzheimer's, Parkinson's, Suicidality, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

160 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Neflamapimod for Lewy Body Dementia?

Research suggests that Neflamapimod, which targets a specific brain process involved in dementia, may be effective for patients with Lewy Body Dementia who also show signs of Alzheimer's disease-related changes, as indicated by a specific blood marker. ^{1 2 3 4 5}

Is Neflamapimod safe for humans?

Phase II trial results for Neflamapimod show promising results, indicating it may be safe for use in humans, but more research is needed to confirm its safety. ^{2 3 5 6 7}

What makes the drug Neflamapimod unique for treating Lewy Body Dementia?

Neflamapimod is unique because it is being investigated as a potential disease-modifying treatment for Lewy Body Dementia, unlike current options that mainly focus on symptom relief. This drug is in phase II trials and shows promising results, which is significant given the lack of FDA-approved treatments specifically for this condition. ^{2 3 4 5 6}

What is the purpose of this trial?

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.

Eligibility Criteria

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

No history of learning difficulties that may interfere with their ability to complete the cognitive tests

Your CDR Global Score is 0.5 or 1.0 during the screening.

Must have reliable informant or caregiver

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neflamapimod or placebo for 16 weeks to assess improvements in cognitive and motor functions

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Neflamapimod

Trial Overview 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.

Participant Groups

Group I: Neflamapimod Active Control 1 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: Placebo Placebo Group 1 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).

Who Is Running the Clinical Trial?

EIP Pharma Inc

Lead Sponsor

Trials

7

Recruited

480+

Founded

Not available

Headquarters

Boston, USA

Known For

CNS Therapeutics

Top Products

Neflamapimod

Worldwide Clinical Trials

Collaborator

Trials

70

Recruited

15,800+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

CervoMed, Inc

Collaborator

Trials

2

Recruited

180+

Findings from Research

Currently, there are no FDA-approved drugs specifically for treating dementia with Lewy bodies (DLB), and only a few options for Parkinson's disease dementia (PDD), with cholinesterase inhibitors like rivastigmine showing benefits for cognitive symptoms.

Ongoing clinical trials, primarily in phase I and II, are exploring new treatments aimed at modifying the disease rather than just alleviating symptoms, with early results for neflamapimod appearing promising.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Therapies and Drug Development Pipeline in Lewy Body Dementia: An Update. MacDonald, S., Shah, AS., Tousi, B.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Association of Plasma Phosphorylated Tau With the Response to Neflamapimod Treatment in Patients With Dementia With Lewy Bodies. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Using Clinical Scales and Digital Measures to Explore Falls in Patients with Lewy Body Dementia. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Memantine for patients with Parkinson's disease dementia or dementia with Lewy bodies: a randomised, double-blind, placebo-controlled trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

RENEWAL: REpurposing study to find NEW compounds with Activity for Lewy body dementia-an international Delphi consensus. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Memantine in patients with Parkinson's disease dementia or dementia with Lewy bodies: a double-blind, placebo-controlled, multicentre trial. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Current Therapies and Drug Development Pipeline in Lewy Body Dementia: An Update. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Emerging drugs for dementia with Lewy Bodies: a review of Phase II & III trials. [2023]