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

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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Recruitment Status : Withdrawn (Pending investigation of an unexpected animal toxicology finding.)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

Tracking Information
First Submitted Date  ICMJE June 25, 2018
First Posted Date  ICMJE July 19, 2018
Last Update Posted Date October 1, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2018)
  • Incidence and severity of treatment related adverse events [ Time Frame: Baseline to 12 weeks ]
    Comparison of HTL0018318 treatment with placebo
  • Change in systolic, diastolic blood pressure and heart rate [ Time Frame: Baseline to 12 weeks ]
    Comparison of HTL0018318 treatment with placebo
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2018)
  • Change from baseline in measures of cognitive impairment [ Time Frame: Baseline to 12 weeks ]
    Comparison of HTL0018318 treatment with placebo
  • Change from baseline in measures of psychosis (i.e. hallucinations and delusions) [ Time Frame: Baseline to 12 weeks ]
    Comparison of HTL0018318 treatment with placebo
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Placebo controlled
Masking: Double (Participant, Investigator)
Masking Description:
Double blind
Primary Purpose: Treatment
Condition  ICMJE Dementia With Lewy Bodies
Intervention  ICMJE
  • Drug: HTL0018318
    Oral capsule
  • Drug: Placebo
    Oral capsule
Study Arms  ICMJE
  • Experimental: HTL0018318 high dose
    oral capsule, once daily
    Intervention: Drug: HTL0018318
  • Experimental: HTL0018318 mid dose
    oral capsule, once daily
    Intervention: Drug: HTL0018318
  • Experimental: HTL0018318 low dose
    oral capsule, once daily
    Intervention: Drug: HTL0018318
  • Placebo Comparator: Placebo
    oral capsule, once daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 30, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2018)
172
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03592862
Other Study ID Numbers  ICMJE HTL0018318-203
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Heptares Therapeutics Limited
Study Sponsor  ICMJE Heptares Therapeutics Limited
Collaborators  ICMJE Sosei
Investigators  ICMJE
Study Chair: Tim Tasker, MBBS Heptares Therapeutics Ltd.
PRS Account Heptares Therapeutics Limited
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP