Dementia With Lewy Bodies
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGHTL0018318
Oral capsule
DRUGPlacebo
Oral capsule
Sponsors
Sosei
Nxera Pharma UK Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blind
Intervention model description
Placebo controlled
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with probable DLB according to the fourth revision of consensus diagnostic criteria for DLB. * Clinical imaging evidence from either SPECT or MIBG cardiac scintigraphy that is consistent with a clinical diagnosis of DLB. * Partner or caregiver able to support the patient for the duration of the clinical trial.
Exclusion criteria
* Patients with a diagnosis of Parkinson disease at least 1 year prior to onset of dementia. * Patients with the presence of severe extrapyramidal symptoms * Patients with the presence of an illness/condition apart from DLB that could contribute to cognitive dysfunction * Patients with poorly controlled hypertension despite lifestyle modifications and/or pharmacotherapy, who are currently on more than 2 different antihypertensive treatments * Patients with prominent, recurrent episodes of syncope are related to orthostatic hypotension * Patients with pulmonary disease or evidence of clinically significant moderate or severe pulmonary symptoms * Patients who are taking a range of prohibited and restricted medication * Patients who have been prescribed individualised cognitive rehabilitation, stimulation or training that was performed under medical supervision in the 6 months prior to the screening visit * Patients who have any known condition(s) that may be contraindicated or interfere with the completion of the nuclear imaging scans.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of treatment related adverse events | Baseline to 12 weeks | Comparison of HTL0018318 treatment with placebo |
| Change in systolic, diastolic blood pressure and heart rate | Baseline to 12 weeks | Comparison of HTL0018318 treatment with placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in measures of cognitive impairment | Baseline to 12 weeks | Comparison of HTL0018318 treatment with placebo |
| Change from baseline in measures of psychosis (i.e. hallucinations and delusions) | Baseline to 12 weeks | Comparison of HTL0018318 treatment with placebo |
Countries
Japan
Outcome results
None listed