Multi-centre Study of HTL0018318 in Patients as an add-on to Standard-of-care

A Phase 1b Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study to Determine the Safety and Tolerability of HTL0018318 in Subjects With Alzheimer's Disease Receiving Standard-of-care

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03456349

Enrollment

Registered

2018-03-07

Start date

2017-11-10

Completion date

2018-07-16

Last updated

2018-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease

Brief summary

Multi-centre study of HTL0018318 in patients with Alzheimer's disease as an add-on to standard-of-care

Detailed description

This is a multi-centre study conducted in four countries. A total of 60 subjects with Alzheimer's disease who are on standard-of-care will be enrolled to receive one of 3 active HTL0018318 or placebo for a period of four weeks

Interventions

DRUGHTL0018318

HTL0018318

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

55 Years to 85 Years

Healthy volunteers

Inclusion criteria

1. Diagnostic evidence of Alzheimer's disease according to the 2011 National Institutes of Aging-Alzheimer's Association (NIA-AA) criteria 2. Participants with Alzheimer's disease on stable standard of care

Exclusion criteria

1. Presence of illness apart from Alzheimer's disease that could contribute to cognitive dysfunction 2. A current or history of clinically significant suicidal ideation within the past 6 months 3. Subjects who have been on anti-cholinergic and/or anti muscarinic treatment

Design outcomes

Primary

Measure	Time frame
Treatment emergent adverse events (TEAEs), Safety and Tolerability	Baseline to Day 28

Countries

Czechia, Poland, Slovakia, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026