A Study to Assess Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies

Phase 2

Withdrawn

• Conditions: Dementia With Lewy Bodies
• Interventions: Drug: HTL0018318; Drug: Placebo

• Registration Number: NCT03592862
• Lead Sponsor: Heptares Therapeutics Limited

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.

Study Timeline

• Study First Submitted: 2018-06-25
• Study First Submitted QC: 2018-07-18
• Study First Posted: 2018-07-19
• Study Start: 2019-07
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-01
• Primary Completion: 2020-07
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HTL0018318 mid dose	HTL0018318	oral capsule, once daily
Placebo	Placebo	oral capsule, once daily
HTL0018318 high dose	HTL0018318	oral capsule, once daily
HTL0018318 low dose	HTL0018318	oral capsule, once daily

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change from baseline in measures of psychosis (i.e. hallucinations and delusions)	Baseline to 12 weeks	Comparison of HTL0018318 treatment with placebo
Change from baseline in measures of cognitive impairment	Baseline to 12 weeks	Comparison of HTL0018318 treatment with placebo

Trial Locations

Locations (3)

Kagawa Prefectural Central Hospital; 🇯🇵 Takamatsu, Japan

Nishitaga Hospital; 🇯🇵 Sendai, Japan

Kurumi Clinic; 🇯🇵 Tokyo, Japan