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

Alzheimer's Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03456349
• Other study ID #: HTL0018318-202
• Secondary ID: 2017-000649-34
• Status: Completed
• Phase: Phase 1
• Start date: November 10, 2017
• Est. completion date: July 16, 2018

Study information

• Verified date: July 2018
• Source: Heptares Therapeutics Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 16, 2018
• Est. primary completion date: July 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• HTL0018318
HTL0018318
• Placebo
Placebo

Locations

Country	Name	City	State
Czechia	Syneos	Prague
Poland	Syneos	Warsaw
Slovakia	Syneos	Bratislava
Spain	Syneos	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Heptares Therapeutics Limited	Allergan

Countries where clinical trial is conducted

Czechia,  Poland,  Slovakia,  Spain, 

Outcome

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