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.

Phase 2

Terminated

• Conditions: Dementia with Lewy bodies (DLB)

• Registration Number: JPRN-jRCT2080223932
• Lead Sponsor: Sosei Co. Ltd. (Global sponsor: Heptares Therapeutics Limited)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: terminated
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

1. Diagnosed with probable DLB according to the fourth revision of consensus diagnostic criteria for DLB.
2. Clinical imaging evidence from either SPECT or MIBG cardiac scintigraphy that is consistent with a clinical diagnosis of DLB.
3. Partner or caregiver able to support the patient for the duration of the clinical trial.

Exclusion Criteria

1. Patients with a diagnosis of Parkinson disease at least 1 year prior to onset of dementia.
2. Patients with the presence of severe extrapyramidal symptoms
3. Patients with the presence of an illness/condition apart from DLB that could contribute to cognitive dysfunction.
4. Patients with poorly controlled hypertension despite lifestyle modifications and/or pharmacotherapy, who are currently on more than 2 different antihypertensive treatments.
5. Patients with prominent, recurrent episodes of syncope are related to orthostatic hypotension.
6. Patients with pulmonary disease or evidence of clinically significant moderate or severe pulmonary symptoms.
7. Patients who are taking a range of prohibited and restricted medications.
8. 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.
9. 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: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>The primary endpoint of this study is as follows:<br>* Safety and tolerability of HTL0018318 compared with placebo as assessed by: <br> - Incidence and severity of adverse events.<br> - Clinically significant changes in physical and neurological examinations, vital signs (e.g. body temperature, heart rate, systolic and diastolic blood pressure), clinical laboratory values, 12-lead electrocardiograms (ECGs), Unified Parkinson's Disease Rating Scale part III (UPDRS-III), and Columbia-Suicide Severity Rating Scale (C-SSRS).

Secondary Outcome Measures

Name	Time	Method
efficacy<br>The secondary efficacy endpoints of this study are: <br>* As a measure of cognitive impairment, change from baseline in HTL0018318 compared with placebo at treatment Week 12 in MMSE score. <br>* As a measure of psychosis, change from baseline in HTL0018318 compared with placebo at treatment Week 12 in the scores of the Delusions (Part A) and Hallucinations (Part B) items from the Neuropsychiatric Inventory-Clinician scale.