To establish the safety and efficacy of HTL0018318 compared with placebo when administered once daily for 12 weeks to patients with dementia with Lewy bodies.
To assess the safety, tolerability and efficacy of HTL0018318 at 3 dose levels (once daily) compared with placebo over a 12-week treatment period in patients with dementia with Lewy bodies (DLB). Approximately 140 DLB patients who have not received donepezil (Aricept®) and/or other acetyl cholinesterase inhibitors (AchEi) and approximately 32 DLB patients who have had prior treatment experience with donepezil but have stopped usage will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Oral capsule
Oral capsule
Nishitaga Hospital
Sendai, Japan
Kagawa Prefectural Central Hospital
Takamatsu, Japan
Kurumi Clinic
Tokyo, Japan
Incidence and severity of treatment related adverse events
Comparison of HTL0018318 treatment with placebo
Time frame: Baseline to 12 weeks
Change in systolic, diastolic blood pressure and heart rate
Comparison of HTL0018318 treatment with placebo
Time frame: Baseline to 12 weeks
Change from baseline in measures of cognitive impairment
Comparison of HTL0018318 treatment with placebo
Time frame: Baseline to 12 weeks
Change from baseline in measures of psychosis (i.e. hallucinations and delusions)
Comparison of HTL0018318 treatment with placebo
Time frame: Baseline to 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.