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

• ClinicalTrials.gov Identifier: NCT03592862
• Recruitment Status: Withdrawn
• First Posted: July 19, 2018
• Last Update Posted: October 1, 2019
• Sponsor: Heptares Therapeutics Limited
• Collaborator: Sosei
• Information provided by (Responsible Party): Heptares Therapeutics Limited

Tracking Information

• First Submitted Date: June 25, 2018
• First Posted Date: July 19, 2018
• Last Update Posted Date: October 1, 2019
• Estimated Study Start Date: July 2019
• Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Assess Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies
• 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
• 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: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Placebo controlled

Masking: Double (Participant, Investigator)
Masking Description:

Double blind

Primary Purpose: Treatment

• Condition: Dementia With Lewy Bodies

Intervention

• Drug: HTL0018318
  Oral capsule
• Drug: Placebo
  Oral capsule

Study Arms

• 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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: September 30, 2019): 0
• Original Estimated Enrollment (submitted: July 18, 2018): 172
• Estimated Study Completion Date: January 2021
• Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT03592862
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Heptares Therapeutics Limited
• Study Sponsor: Heptares Therapeutics Limited
• Collaborators: Sosei

Investigators

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

• PRS Account: Heptares Therapeutics Limited
• Verification Date: September 2019