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

NCT03592862 | Withdrawn Phase 2 DMC

• 1 other identifier: HTL0018318-203
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Dementia With Lewy Bodies

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of treatment related adverse events

  Comparison of HTL0018318 treatment with placebo

  Baseline to 12 weeks

• Change in systolic, diastolic blood pressure and heart rate

  Comparison of HTL0018318 treatment with placebo

  Baseline to 12 weeks

Secondary Outcomes (2)

• Change from baseline in measures of cognitive impairment

  Baseline to 12 weeks

• Change from baseline in measures of psychosis (i.e. hallucinations and delusions)

  Baseline to 12 weeks

Study Arms (4)

HTL0018318 high dose

EXPERIMENTAL

oral capsule, once daily

Drug: HTL0018318

HTL0018318 mid dose

EXPERIMENTAL

oral capsule, once daily

Drug: HTL0018318

HTL0018318 low dose

EXPERIMENTAL

oral capsule, once daily

Drug: HTL0018318

Placebo

PLACEBO COMPARATOR

oral capsule, once daily

Drug: Placebo

Interventions

HTL0018318 DRUG

Oral capsule

HTL0018318 high dose; HTL0018318 low dose; HTL0018318 mid dose

Placebo DRUG

Oral capsule

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nxera Pharma UK Limited: lead
• Sosei: collaborator

Study Sites (3)

Nishitaga Hospital

Sendai, Japan

Location

Kagawa Prefectural Central Hospital

Takamatsu, Japan

Location

Kurumi Clinic

Tokyo, Japan

Location

MeSH Terms

Conditions

Lewy Body Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Tim Tasker, MBBS

  Heptares Therapeutics Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo controlled

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 19, 2018
• Study Start: July 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: January 1, 2021
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3)