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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
HTL0018318
Placebo
Sponsored by
Heptares Therapeutics Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Syneos
  • Syneos
  • Syneos
  • Syneos

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Low dose

Medium dose

High dose

Placebo

Arm Description

HTL0018318

HTL0018318

HTL0018318

Placebo

Outcomes

Primary Outcome Measures

Treatment emergent adverse events (TEAEs), Safety and Tolerability

Secondary Outcome Measures

Full Information

First Posted
February 22, 2018
Last Updated
July 19, 2018
Sponsor
Heptares Therapeutics Limited
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT03456349
Brief Title
Multi-centre Study of HTL0018318 in Patients as an add-on to Standard-of-care
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 10, 2017 (Actual)
Primary Completion Date
July 16, 2018 (Actual)
Study Completion Date
July 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heptares Therapeutics Limited
Collaborators
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose
Arm Type
Experimental
Arm Description
HTL0018318
Arm Title
Medium dose
Arm Type
Experimental
Arm Description
HTL0018318
Arm Title
High dose
Arm Type
Experimental
Arm Description
HTL0018318
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
HTL0018318
Intervention Description
HTL0018318
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Treatment emergent adverse events (TEAEs), Safety and Tolerability
Time Frame
Baseline to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Syneos
City
Prague
Country
Czechia
Facility Name
Syneos
City
Warsaw
Country
Poland
Facility Name
Syneos
City
Bratislava
Country
Slovakia
Facility Name
Syneos
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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