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

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

Sponsors

Lead sponsor: Heptares Therapeutics Limited

Collaborator: Sosei

Source 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.

Overall Status Withdrawn
Start Date July 2019
Completion Date January 2021
Primary Completion Date July 2020
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence and severity of treatment related adverse events Baseline to 12 weeks
Change in systolic, diastolic blood pressure and heart rate Baseline to 12 weeks
Secondary Outcome
Measure Time Frame
Change from baseline in measures of cognitive impairment Baseline to 12 weeks
Change from baseline in measures of psychosis (i.e. hallucinations and delusions) Baseline to 12 weeks
Condition
Intervention

Intervention type: Drug

Intervention name: HTL0018318

Description: Oral capsule

Intervention type: Drug

Intervention name: Placebo

Description: Oral capsule

Arm group label: Placebo

Eligibility

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.

Gender: All

Minimum age: 50 Years

Maximum age: 85 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Tim Tasker, MBBS Study Chair Heptares Therapeutics Ltd.
Location
facility
Nishitaga Hospital | Sendai, Japan
Kagawa Prefectural Central Hospital | Takamatsu, Japan
Kurumi Clinic | Tokyo, Japan
Location Countries

Japan

Verification Date

September 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Arm group label: HTL0018318 high dose

Arm group type: Experimental

Description: oral capsule, once daily

Arm group label: HTL0018318 mid dose

Arm group type: Experimental

Description: oral capsule, once daily

Arm group label: HTL0018318 low dose

Arm group type: Experimental

Description: oral capsule, once daily

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: oral capsule, once daily

Acronym DLB
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Placebo controlled

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Masking description: Double blind

Source: ClinicalTrials.gov