Multi-centre Study of HTL0018318 in Patients as an add-on... | NCT03456349

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

NCT03456349

Sponsor

Nxera Pharma UK Limited

Status

Completed

Last Update Posted

Jul 20, 2018Actual

Enrollment

60Actual

Phase

Phase 1

Conditions

Alzheimer's Disease

Interventions

HTL0018318
Placebo

Countries

Czechia
Poland
Slovakia
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2017-000649-34	EudraCT Number

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2017Actual

Primary Completion Date

Jul 16, 2018Actual

Completion Date

Jul 16, 2018Actual

First Submitted Date

Feb 22, 2018

First Submission Date that Met QC Criteria

Mar 5, 2018

First Posted Date

Mar 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2018

Last Update Posted Date

Jul 20, 2018Actual

Name	Class
Allergan	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low dose	Experimental	HTL0018318	Drug: HTL0018318
Medium dose	Experimental	HTL0018318	Drug: HTL0018318
High dose	Experimental	HTL0018318	Drug: HTL0018318
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HTL0018318	Drug	HTL0018318	High dose Low dose Medium dose

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Syneos		Prague			Czechia
Syneos