Table 1. Current status of clinical development of brexpiprazole and pimavanserin for the treatment of agitation and psychosis in Alzheimer’s disease.
| Drug | Indication/Field | Phase of
study of action |
Duration | Sample
size |
Dosing | Main result or status or both |
|---|---|---|---|---|---|---|
| Brexpiprazole | Agitation | III
Clinical trial: NCT01862640 |
12 weeks | 433
AD subjects |
2mg/day
Fixed dose |
Brexpiprazole demonstrated
superior efficacy versus placebo as assessed by CMAI. Safe and well-tolerated |
| Brexpiprazole | Agitation | III
Clinical trial: NCT01922258 |
12 weeks | 270
AD subjects |
Flexible dose
in the range of 0.5–2 mg/day |
Patients who were titrated to
brexpiprazole 2 mg/day at week 4 demonstrated superiority versus matched placebo as assessed by CMAI. |
| Brexpiprazole | Agitation | III
Clinical trials: NCT03724942, NCT03594123, NCT03620981 |
14 weeks 12 weeks 10 weeks |
157 AD 250 AD 407 AD |
1–2 mg 2–3 mg 1–2 mg |
Ongoing
To evaluate the long-term safety and clinical efficacy of brexpiprazole |
| Pimavanserin | Psychosis | II | 12 weeks | 181 AD | 34 mg once daily | Large treatment effects in
AD patients with more severe psychosis at baseline (NPI-NH- PS ≥12) |
| Pimavanserin | Psychosis | III
Clinical trial: NCT03325556 |
38 weeks
12 weeks Open- label + 26 weeks Double- blind period |
360
patients with DRP |
20 mg or 34 mg
once daily based on their open- label phase |
Ongoing
A long-term relapse prevention study of pimavanserin for the treatment of hallucinations and delusions associated with DRP |
AD, Alzheimer’s disease; CMAI, Cohen-Mansfield Agitation Inventory; DRP, dementia-related psychosis; NPI-NH-PS, Neuropsychiatric Inventory-Nursing Home Version psychosis score