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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03456349
Recruitment Status : Completed
First Posted : March 7, 2018
Last Update Posted : July 20, 2018
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Heptares Therapeutics Limited

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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: HTL0018318 Drug: Placebo Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 10, 2017
Actual Primary Completion Date : July 16, 2018
Actual Study Completion Date : July 16, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Low dose
HTL0018318
 Drug: HTL0018318
HTL0018318
Experimental: Medium dose
HTL0018318
 Drug: HTL0018318
HTL0018318
Experimental: High dose
HTL0018318
 Drug: HTL0018318
HTL0018318
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Treatment emergent adverse events (TEAEs), Safety and Tolerability [ Time Frame: Baseline to Day 28 ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456349


Locations
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Czechia
Syneos
Prague, Czechia
Poland
Syneos
Warsaw, Poland
Slovakia
Syneos
Bratislava, Slovakia
Spain
Syneos
Barcelona, Spain
Sponsors and Collaborators
Heptares Therapeutics Limited
Allergan
More Information
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Responsible Party: Heptares Therapeutics Limited
ClinicalTrials.gov Identifier: NCT03456349    
Other Study ID Numbers: HTL0018318-202
2017-000649-34 ( EudraCT Number )
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heptares Therapeutics Limited:
Alzheimer's disease
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders