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.

Sosei Co. Ltd. (Global sponsor: Heptares Therapeutics Limited)0 个研究点目标入组 172 人开始时间: 2018年6月6日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

Sosei Co. Ltd. (Global sponsor: Heptares Therapeutics Limited)