Clinical trial NCT03592862: A Study to Assess Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies
Official title: A Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Assess the Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Dementia With Lewy Bodies
Lead sponsor: Nxera Pharma UK Limited
Sponsor class: INDUSTRY
Collaborators: name: Sosei
First posted: 2018-07-19
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo controlled
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and severity of treatment related adverse events
timeFrame: Baseline to 12 weeks
measure: Change in systolic, diastolic blood pressure and heart rate
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change from baseline in measures of cognitive impairment
timeFrame: Baseline to 12 weeks
measure: Change from baseline in measures of psychosis (i.e. hallucinations and delusions)
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Sendai
country: Japan
facility: Nishitaga Hospital
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital
city: Tokyo
country: Japan
facility: Kurumi Clinic
Study officials:
affiliation: Heptares Therapeutics Ltd.
name: Tim Tasker, MBBS
role: STUDY_CHAIR
References: