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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03592862
Recruitment Status : Withdrawn (Pending investigation of an unexpected animal toxicology finding.)
First Posted : July 19, 2018
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Sosei
Information provided by (Responsible Party):
Heptares Therapeutics Limited

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dementia With Lewy Bodies Drug: HTL0018318 Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Placebo controlled
Masking: Double (Participant, Investigator)
Masking Description: Double blind
Primary Purpose: Treatment
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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and severity of treatment related adverse events [ Time Frame: Baseline to 12 weeks ]
    Comparison of HTL0018318 treatment with placebo

  2. Change in systolic, diastolic blood pressure and heart rate [ Time Frame: Baseline to 12 weeks ]
    Comparison of HTL0018318 treatment with placebo


Secondary Outcome Measures :
  1. Change from baseline in measures of cognitive impairment [ Time Frame: Baseline to 12 weeks ]
    Comparison of HTL0018318 treatment with placebo

  2. Change from baseline in measures of psychosis (i.e. hallucinations and delusions) [ Time Frame: Baseline to 12 weeks ]
    Comparison of HTL0018318 treatment with placebo


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592862


Locations
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Japan
Nishitaga Hospital
Sendai, Japan
Kagawa Prefectural Central Hospital
Takamatsu, Japan
Kurumi Clinic
Tokyo, Japan
Sponsors and Collaborators
Heptares Therapeutics Limited
Sosei
Investigators
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Study Chair: Tim Tasker, MBBS Heptares Therapeutics Ltd.
More Information
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Responsible Party: Heptares Therapeutics Limited
ClinicalTrials.gov Identifier: NCT03592862    
Other Study ID Numbers: HTL0018318-203
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
 Mental Disorders
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Synucleinopathies