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

Nxera Pharma UK Limited60 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Alzheimer's Disease

Interventions

HTL0018318DRUG

HTL0018318

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 55 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (4)

Syneos

Prague, Czechia

Syneos

Warsaw, Poland

Syneos

Bratislava, Slovakia

Syneos

Barcelona, Spain

Outcomes

Primary Outcomes

Treatment emergent adverse events (TEAEs), Safety and Tolerability

Time frame: Baseline to Day 28

Data from ClinicalTrials.gov

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