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

Heptares Therapeutics

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: Placebo; Drug: HTL0018318

Study type: Interventional

Funder types: Industry

Identifiers

NCT03456349

2017-000649-34 (EudraCT Number)

HTL0018318-202

Details and patient eligibility

About

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

Full 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

Enrollment: 60 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 4 patient groups, including a placebo group

Low dose

Experimental group

Description:

HTL0018318

Treatment:

Drug: HTL0018318

Medium dose

Experimental group

Description:

HTL0018318

Treatment:

Drug: HTL0018318

High dose

Experimental group

Description:

HTL0018318

Treatment:

Drug: HTL0018318

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo