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

July 19, 2018 updated by: Heptares Therapeutics Limited

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: Low dose
HTL0018318
Drug: HTL0018318
HTL0018318
Experimental: Medium dose
HTL0018318
Drug: HTL0018318
HTL0018318
Experimental: High dose
HTL0018318
Drug: HTL0018318
HTL0018318

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heptares Therapeutics Limited

Collaborators

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2017

Primary Completion (Actual)

July 16, 2018

Study Completion (Actual)

July 16, 2018

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

March 5, 2018

First Posted (Actual)

March 7, 2018

Study Record Updates

Last Update Posted (Actual)

July 20, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTL0018318-202
  • 2017-000649-34 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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