Trials / Withdrawn
WithdrawnNCT03592862
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
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Nxera Pharma UK Limited · Industry
- Sex
- All
- Age
- 50 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HTL0018318 | Oral capsule |
| DRUG | Placebo | Oral capsule |
Timeline
- Start date
- 2019-07-01
- Primary completion
- 2020-07-01
- Completion
- 2021-01-01
- First posted
- 2018-07-19
- Last updated
- 2019-10-01
Locations
3 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03592862. Inclusion in this directory is not an endorsement.