- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03592862
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Withdrawn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
-
-
-
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
|
Oral capsule
|
EXPERIMENTAL: HTL0018318 mid dose
oral capsule, once daily
|
Oral capsule
|
EXPERIMENTAL: HTL0018318 low dose
oral capsule, once daily
|
Oral capsule
|
PLACEBO_COMPARATOR: Placebo
oral capsule, once daily
|
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
Collaborators
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.
Clinical Trials on Dementia With Lewy Bodies
-
EIP Pharma IncWorldwide Clinical TrialsCompletedDementia With Lewy Bodies (DLB)United States, Netherlands
-
Osaka UniversityCompletedDementia With Lewy Bodies (DLB)Japan
-
Eisai Inc.CompletedDementias With Lewy BodiesUnited States
-
University Hospital, Strasbourg, FranceRecruitingDementia With Lewy Bodies Diagnosis | Significant Cognitive Fluctuations in DLBFrance
-
Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)Japan
-
Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)
-
Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)Japan
-
Eisai Co., Ltd.Completed
-
CND Life SciencesNational Institute on Aging (NIA)RecruitingMCI-AD, Early Stage Alzheimer's Disease | MCI-DLB, Early Stage Dementia With Lewy BodiesUnited States
-
Cognition TherapeuticsNational Institute on Aging (NIA)RecruitingDementia With Lewy BodiesUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States