Multi-centre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated With Parkinson's Disease

Summary

To demonstrate the superiority of donepezil over placebo in improving cognitive function, neuropsychiatric burden and functional ability in people with Parkinson's disease and mild dementia after 24 months of treatment.

To demonstrate the superiority of donepezil over placebo in improving patient and carer quality of life and to establish the cost-effectiveness of donepezil.

To determine the instrument most suitable for evaluating change in cognition in people with Parkinson's disease and mild dementia.

Conditions

• Parkinson's Disease

Interventions

DRUG

Donepezil

5mg donepezil daily for first 8 weeks and then increased to 10mg daily for the remainder of the study.

Sponsors & Collaborators

• University of Birmingham

  collaborator OTHER

• Bangor University

  collaborator OTHER

• University of Newcastle Upon-Tyne

  collaborator OTHER

• University of Cambridge

  collaborator OTHER

• University of Manchester

  collaborator OTHER

• London School of Economics and Political Science

  collaborator OTHER

• University College, London

  collaborator OTHER

• Lancashire Care NHS Foundation Trust

  collaborator NETWORK

• Newcastle University

  collaborator OTHER

• King's College London

  collaborator OTHER

• Newcastle-upon-Tyne Hospitals NHS Trust

  lead OTHER

Principal Investigators

• David J Burn, Professor · Newcastle University

• Roger A Barker, Dr · Cambridge University

• Belinda Braithwaite, Mrs · lay person

• Alistair Burns, Professor · School of Community Based Medicine, University of Manchester

• Carl E Clarke, Professor · Clarke

• Elaine McColl, Professor · University of Newcastle Upon-Tyne

• John V Hindle, Dr · Llandudno Hospital & University of College Wales

• Martin Knapp, Professor · London School of Economics and Political Science

• Andrew J Lees, Professor · University College, London

• Iracema Leroi, DR · Lancashire Care Trust, Royal Blackburn Hospital

• Ian G McKeith, Professor · Newcastle University

• John T O'Brien, Professor · Newcastle University

• Keith Wheatley, Professor · Cancer Research UK Clinical Trials Unit, School of Cancer Sciences, University of Birmingham

• Ian N Steen, Dr · University of Newcastle Upon-Tyne

• Jennifer Wilkinson, Mrs · University of Newcastle Upon-Tyne

• Sharon Erb, Mrs · University of Newcastle Upon-Tyne

• Daniel Weintraub · Associate Professor of Psychiatry and Neurology, Perelman School of Medicine at the University of Pennsylvania

• Lynn Rochester · Professor of Human Movement Science, Institute for Ageing and Health, Newcastle University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2014-09-30

Completion

2014-09-30

Countries

• United Kingdom

Study Locations