Dementia With Lewy BodiesPhase 2DLBNCT03592862
A Study to Assess Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies
A Phase 2 study testing HTL0018318 in people with Dementia With Lewy Bodies, run by Nxera Pharma UK Limited at 3 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Dementia With Lewy Bodies
- What is being tested?
- HTL0018318
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesJapan
- Study dates
- Jul 2019to Jan 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Nishitaga Hospital
Sendai
Kagawa Prefectural Central Hospital
Takamatsu
Kurumi Clinic
Tokyo
About this study
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
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.
Read the 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.
- Conditions
- Dementia With Lewy Bodies
- Being tested
- HTL0018318, Placebo
- Medical subject headings
- Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTL0018318Drug
Oral capsule
PlaceboDrug
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| HTL0018318 high dose | Experimental | oral capsule, once daily Receives: Drug: HTL0018318 |
| HTL0018318 mid dose | Experimental | oral capsule, once daily Receives: Drug: HTL0018318 |
| HTL0018318 low dose | Experimental | oral capsule, once daily Receives: Drug: HTL0018318 |
| Placebo | Placebo comparator | oral capsule, once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment related adverse events
Comparison of HTL0018318 treatment with placebo
Measured: Baseline to 12 weeks
Change in systolic, diastolic blood pressure and heart rate
Comparison of HTL0018318 treatment with placebo
Measured: Baseline to 12 weeks
Secondary outcomes (2)
Change from baseline in measures of cognitive impairment
Comparison of HTL0018318 treatment with placebo
Measured: Baseline to 12 weeks
Change from baseline in measures of psychosis (i.e. hallucinations and delusions)
Comparison of HTL0018318 treatment with placebo
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study startJul 2019 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionJan 2021 (estimated)
Why it stopped: Pending investigation of an unexpected animal toxicology finding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia With Lewy BodiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nxera Pharma UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sosei
- Responsible party
- Sponsor
- Investigators
- Tim Tasker, MBBS, Study chair, Heptares Therapeutics Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592862
- Sponsor's protocol ID
- HTL0018318-203
- Acronym
- DLB
- Status last verified
- Sep 2019
- First submitted
- 25 Jun 2018
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03592862
- Acronym / sponsor ID
- DLB / HTL0018318-203
- Conditions
- Dementia With Lewy Bodies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Pending investigation of an unexpected animal toxicology finding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nxera Pharma UK LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Sosei
- Study start
- Jul 2019 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Placebo controlled
| Arm | Type | Receives |
|---|---|---|
| HTL0018318 high dose | Experimental | Drug: HTL0018318oral capsule, once daily |
| HTL0018318 mid dose | Experimental | Drug: HTL0018318oral capsule, once daily |
| HTL0018318 low dose | Experimental | Drug: HTL0018318oral capsule, once daily |
| Placebo | Placebo comparator | Drug: Placebooral capsule, once daily |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HTL0018318Oral capsule | Drug | HTL0018318 high dose, HTL0018318 low dose, HTL0018318 mid dose |
| PlaceboOral capsule | Drug | Placebo |
Primary outcome
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
2 secondary outcomes
Change from baseline in measures of cognitive impairment
Time frame: Baseline to 12 weeks
Change from baseline in measures of psychosis (i.e. hallucinations and delusions)
Time frame: Baseline to 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Tasker, MBBS study chair
Heptares Therapeutics Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HTL0018318 in people with Dementia With Lewy Bodies, run by Nxera Pharma UK Limited at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment related adverse events (time frame: Baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.