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

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: HTL0018318; Drug: Placebo

• Registration Number: NCT03456349
• Lead Sponsor: Heptares Therapeutics Limited

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

Study Timeline

• Study Start: 2017-11-10
• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-03-05
• Study First Posted: 2018-03-07
• Status Verified: 2018-07
• Primary Completion: 2018-07-16
• Study Completion: 2018-07-16
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose	HTL0018318	HTL0018318
Placebo	Placebo	Placebo
Low dose	HTL0018318	HTL0018318
Medium dose	HTL0018318	HTL0018318

Primary Outcome Measures

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

Trial Locations

Locations (1)

Syneos; 🇪🇸 Barcelona, Spain