Rewin-DLB
Research type
Research Study
Full title
A Phase 2b Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients with Dementia with Lewy Bodies (DLB)
IRAS ID
1007697
Contact name
Jennifer Conway
Contact email
Sponsor organisation
EIP Pharma, Inc.
Eudract number
2023-504373-20
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to determine whether the study drug (neflamapimod) can improve learning skills, problem solving skills, and motor function in people diagnosed with Dementia with Lewy Bodies (DLB). This research study will compare function and attention in patients with DLB after taking neflamapimod or placebo to see whether the study drug leads to any improvement. The study will take place at both NHS and non-NHS sites.
This is a double-blind (neither the patient, the caregiver, the study doctor, or study staff will know which treatment is received). To try to make sure the study groups are equally split, each patient is put into a group by chance (randomly). The results are compared to see if one treatment is better than the other.
Participants will receive the study drug (neflamapimod or placebo) in the form of a capsule and will take them by mouth with food, three times a day. The treatment duration is 16 weeks (about 4 months). The patient should take the study treatment with breakfast, lunch, dinner, or a snack. The drug must be taken around the same times each day and at least 3 hours apart. 160 subjects aged ≥ 55 years are planned to be enrolled, for a total of up to 23 weeks of study participation (21 days of screening window, 16 weeks of treatment, a 2-week follow-up visit).
After completion of 16 weeks of treatment, participants will be offered an opportunity to take part in an extension of the study, receiving the study drug for an additional 32 weeks (about 8 months).REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
23/EM/0176
Date of REC Opinion
21 Sep 2023
REC opinion
Further Information Favourable Opinion