Neflamapimod for Lewy Body Dementia

Recruiting at 46 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: EIP Pharma Inc

Prior Safety Data

Trial Summary

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.

Research Team

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.

Treatment Details

Interventions

• Neflamapimod (Kinase Inhibitor)

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+

Peter Benton

Worldwide Clinical Trials

Chief Executive Officer since 2024

MBA in Finance and Strategy from The Wharton School, University of Pennsylvania; Bachelor's degree in Mechanical Engineering from Northeastern University

Dr. Michael F. Murphy

Worldwide Clinical Trials

Chief Medical Officer since 1997

MD and PhD in Pharmacology with training at Tulane University, Stanford University, and Mt. Sinai School of Medicine

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School

CervoMed, Inc

Collaborator

Trials

2

Recruited

180+