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

• Status: Withdrawn
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heptares Therapeutics Limited
• Collaborator: Sosei

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.