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

September 30, 2019 updated by: Heptares Therapeutics Limited

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Sendai, Japan
        • Nishitaga Hospital
      • Takamatsu, Japan
        • Kagawa Prefectural Central Hospital
      • Tokyo, Japan
        • Kurumi CLINIC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HTL0018318 high dose
oral capsule, once daily
Drug: HTL0018318
Oral capsule
EXPERIMENTAL: HTL0018318 mid dose
oral capsule, once daily
Drug: HTL0018318
Oral capsule
EXPERIMENTAL: HTL0018318 low dose
oral capsule, once daily
Drug: HTL0018318
Oral capsule
PLACEBO_COMPARATOR: Placebo
oral capsule, once daily
Drug: Placebo
Oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of treatment related adverse events
Time Frame: Baseline to 12 weeks
Comparison of HTL0018318 treatment with placebo
Baseline to 12 weeks
Change in systolic, diastolic blood pressure and heart rate
Time Frame: Baseline to 12 weeks
Comparison of HTL0018318 treatment with placebo
Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in measures of cognitive impairment
Time Frame: Baseline to 12 weeks
Comparison of HTL0018318 treatment with placebo
Baseline to 12 weeks
Change from baseline in measures of psychosis (i.e. hallucinations and delusions)
Time Frame: Baseline to 12 weeks
Comparison of HTL0018318 treatment with placebo
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heptares Therapeutics Limited

Collaborators

Sosei

Investigators

  • Study Chair: Tim Tasker, MBBS, Heptares Therapeutics Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2019

Primary Completion (ANTICIPATED)

July 1, 2020

Study Completion (ANTICIPATED)

January 1, 2021

Study Registration Dates

First Submitted

June 25, 2018

First Submitted That Met QC Criteria

July 18, 2018

First Posted (ACTUAL)

July 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTL0018318-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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