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Completed

NCT Number: NCT03456349

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

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

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Syneos, Prague, Czechia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

HTL0018318

Drug

HTL0018318

Placebo

Drug

Placebo

Primary outcomes

  1. Treatment emergent adverse events (TEAEs), Safety and Tolerability

    Time frame: Baseline to Day 28

Sponsors and collaborators

Lead sponsor

Nxera Pharma UK Limited

Industry

Collaborators

  • Allergan

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2018
Registry last updated
Jul 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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