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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-10

Study Completion Date

2018-07-16

Brief Summary

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

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Detailed Description

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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

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Low dose

HTL0018318

Group Type EXPERIMENTAL

HTL0018318

Intervention Type DRUG

HTL0018318

Medium dose

HTL0018318

Group Type EXPERIMENTAL

HTL0018318

Intervention Type DRUG

HTL0018318

High dose

HTL0018318

Group Type EXPERIMENTAL

HTL0018318

Intervention Type DRUG

HTL0018318

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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HTL0018318

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility 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

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No