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CompletedNCT03456349Updated Jul 20, 2018

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

A Phase 1 interventional study of HTL0018318 and Placebo in Alzheimer's Disease, sponsored by Nxera Pharma UK Limited. Completed at 4 sites in 4 countries. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-07-20.

Sponsored by Nxera Pharma UK Limited · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
55 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Alzheimer's Disease

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Keywords

  • Alzheimer's disease
03

Who can participate

Ages eligible
55 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Low dose

    HTL0018318

    Drug: HTL0018318

  • Experimental
    Medium dose

    HTL0018318

    Drug: HTL0018318

  • Experimental
    High dose

    HTL0018318

    Drug: HTL0018318

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

Interventions

  • DrugHTL0018318

    HTL0018318

  • DrugPlacebo

    Placebo

05

What researchers measure

Primary outcomes

  1. Treatment emergent adverse events (TEAEs), Safety and Tolerability

    Time frame: Baseline to Day 28

06

Study locations

4 sites
  • Syneos
    Prague, Czechia
  • Syneos
    Warsaw, Poland
  • Syneos
    Bratislava, Slovakia
  • Syneos
    Barcelona, Spain
07

Registry details

Key details

Study ID
NCT03456349
Lead sponsor
Nxera Pharma UK Limited
Collaborators
Allergan
Responsible party
Sponsor
First posted
Mar 7, 2018
Start date
Nov 10, 2017
Primary completion
Jul 16, 2018
Completion
Jul 16, 2018
Last update
Jul 20, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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