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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03456349 |
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Date of registration:
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22/02/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Multi-centre Study of HTL0018318 in Patients as an add-on to Standard-of-care
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Scientific title:
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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 |
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Date of first enrolment:
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November 10, 2017 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03456349 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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Czechia
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Poland
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Slovakia
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Spain
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Key inclusion & exclusion criteria
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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
Age minimum:
55 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Alzheimer's Disease
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Intervention(s)
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Drug: Placebo
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Drug: HTL0018318
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Primary Outcome(s)
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Treatment emergent adverse events (TEAEs), Safety and Tolerability
[Time Frame: Baseline to Day 28]
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Secondary ID(s)
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2017-000649-34
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HTL0018318-202
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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