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

Primary Purpose

Dementia With Lewy Bodies

Status
Withdrawn
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
HTL0018318
Placebo
Sponsored by
Heptares Therapeutics Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia With Lewy Bodies

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nishitaga Hospital
  • Kagawa Prefectural Central Hospital
  • Kurumi Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

HTL0018318 high dose

HTL0018318 mid dose

HTL0018318 low dose

Placebo

Arm Description

oral capsule, once daily

oral capsule, once daily

oral capsule, once daily

oral capsule, once daily

Outcomes

Primary Outcome Measures

Incidence and severity of treatment related adverse events
Comparison of HTL0018318 treatment with placebo
Change in systolic, diastolic blood pressure and heart rate
Comparison of HTL0018318 treatment with placebo

Secondary Outcome Measures

Change from baseline in measures of cognitive impairment
Comparison of HTL0018318 treatment with placebo
Change from baseline in measures of psychosis (i.e. hallucinations and delusions)
Comparison of HTL0018318 treatment with placebo

Full Information

First Posted
June 25, 2018
Last Updated
September 30, 2019
Sponsor
Heptares Therapeutics Limited
Collaborators
Sosei
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1. Study Identification

Unique Protocol Identification Number
NCT03592862
Brief Title
A Study to Assess Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Pending investigation of an unexpected animal toxicology finding.
Study Start Date
July 2019 (Anticipated)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heptares Therapeutics Limited
Collaborators
Sosei

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia With Lewy Bodies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Placebo controlled
Masking
ParticipantInvestigator
Masking Description
Double blind
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HTL0018318 high dose
Arm Type
Experimental
Arm Description
oral capsule, once daily
Arm Title
HTL0018318 mid dose
Arm Type
Experimental
Arm Description
oral capsule, once daily
Arm Title
HTL0018318 low dose
Arm Type
Experimental
Arm Description
oral capsule, once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
oral capsule, once daily
Intervention Type
Drug
Intervention Name(s)
HTL0018318
Intervention Description
Oral capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral capsule
Primary Outcome Measure Information:
Title
Incidence and severity of treatment related adverse events
Description
Comparison of HTL0018318 treatment with placebo
Time Frame
Baseline to 12 weeks
Title
Change in systolic, diastolic blood pressure and heart rate
Description
Comparison of HTL0018318 treatment with placebo
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in measures of cognitive impairment
Description
Comparison of HTL0018318 treatment with placebo
Time Frame
Baseline to 12 weeks
Title
Change from baseline in measures of psychosis (i.e. hallucinations and delusions)
Description
Comparison of HTL0018318 treatment with placebo
Time Frame
Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Tasker, MBBS
Organizational Affiliation
Heptares Therapeutics Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Nishitaga Hospital
City
Sendai
Country
Japan
Facility Name
Kagawa Prefectural Central Hospital
City
Takamatsu
Country
Japan
Facility Name
Kurumi Clinic
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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