Subjects aged ≥55 years with probable Dementia with Lewy Bodies DLB by consensus criteria (McKeith et al, 2017), including a positive DaTscan™ and a CDR Global Score of 0.5 or 1.0. If the DaTscan is negative, but the subject has historical polysomnography (PSG)-verified REM sleep behavioral disorder (RBD), this will also qualify as probable DLB.
Conditions
Brief summary
Change (from Baseline to Week 16) in CDR-SB in neflamapimod treated-subjects compared to the placebo-treated subjects.
Detailed description
Change (from Baseline to Week 16) in TUG in neflamapimod-treated subjects compared to placebo-recipients., Change (from Baseline to Week 16) in the composite score of the NTB, including tests of attention, executive function, and visual learning in neflamapimod-treated subjects compared to placebo-recipients., ADCS-CGIC score at Week 16 in neflamapimod-treated subjects compared to placebo-recipients.
Interventions
DRUGOpaque
DRUGUnmarked
DRUGNeflamapimod
DRUGcapsules are reddish-orange opaque hard gelatin capsules with no markings containing a yellow powder.
The complete statement of components and composition of Placebo Capsules to match the 40 mg active capsules is:
- Lactose Monohydrate
- Croscarmellose Sodium
- Povidone K30 USP Binder
- Magnesium Stearate
DRUGNon-Bovine (Hyqual)
- Capsules
DRUGEmpty
DRUGHard Gelatin Size 0
DRUGSwedish Orange
Sponsors
Eip Pharma Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change (from Baseline to Week 16) in CDR-SB in neflamapimod treated-subjects compared to the placebo-treated subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change (from Baseline to Week 16) in TUG in neflamapimod-treated subjects compared to placebo-recipients., Change (from Baseline to Week 16) in the composite score of the NTB, including tests of attention, executive function, and visual learning in neflamapimod-treated subjects compared to placebo-recipients., ADCS-CGIC score at Week 16 in neflamapimod-treated subjects compared to placebo-recipients. | — |
Countries
Netherlands
Outcome results
None listed