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

Dementia With Lewy Bodies Clinical Trial

— DLB  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03592862
• Other study ID #: HTL0018318-203
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 2019
• Est. completion date: January 2021

Study information

• Verified date: September 2019
• Source: Heptares Therapeutics Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2021
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Dementia With Lewy Bodies
• Lewy Body Disease

Intervention

Drug:
• HTL0018318
Oral capsule
• Placebo
Oral capsule

Locations

Country	Name	City	State
Japan	Nishitaga Hospital	Sendai
Japan	Kagawa Prefectural Central Hospital	Takamatsu
Japan	Kurumi Clinic	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Heptares Therapeutics Limited	Sosei

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of treatment related adverse events	Comparison of HTL0018318 treatment with placebo	Baseline to 12 weeks
Primary	Change in systolic, diastolic blood pressure and heart rate	Comparison of HTL0018318 treatment with placebo	Baseline to 12 weeks
Secondary	Change from baseline in measures of cognitive impairment	Comparison of HTL0018318 treatment with placebo	Baseline to 12 weeks
Secondary	Change from baseline in measures of psychosis (i.e. hallucinations and delusions)	Comparison of HTL0018318 treatment with placebo	Baseline to 12 weeks