DLB

WithdrawnPhase 2

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

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

Lead sponsor

Nxera Pharma UK Limited

Asset

HTL0018318

Listed sites

Recruiting sites

Enrollment

actual

Study population

Lewy body dementia

Key I/E criterion

•Dementia with Lewy bodies

Primary endpoints

•Incidence and severity of treatment related adverse events•Systolic, diastolic blood pressure and heart rate

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDHTL0018318-203

NCT IDNCT03592862

Timeline

Milestones

Study first posted2018-07-19actual

Study start2019-07estimated (month precision)

Last update posted2019-10-01actual

Primary completion2020-07estimated (month precision)

Study completion2021-01estimated (month precision)

Assets

Drug assets

HTL0018318

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Safety / tolerability / PK

Other clinical outcomes

Other (unclassified)

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

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

Time frame:Baseline to 12 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Incidence and severity of treatment related adverse events

Time frame:Baseline to 12 weeks

event count, event

Other clinical outcomes

1 endpoint

Primary/protocol endpoint

Change in systolic, diastolic blood pressure and heart rate

Time frame:Baseline to 12 weeks

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change from baseline in measures of cognitive impairment

Time frame:Baseline to 12 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.