2017), but the subject has historical polysomnography (PSG)-verified REM sleep behavioral disorder (RBD), including a positive DaTscan™ and a CDR Global Score of 0.5 or 1.0. If the DaTscan is negative, Subjects aged ≥55 years with probable Dementia with Lewy Bodies DLB by consensus criteria (McKeith et al, 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