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Search / Trial NCT00142324

Trial Information

Current as of July 02, 2025

Unknown status

Keywords

Dementia

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria: a diagnosis of dementia consistent with Diagnostic and Statistical Manual of Mental Health Disorders, revised 3rd edition (DSM-III-R) (APA, 1987) National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) diagnostic criteria for probably or possible AD (MKhann et al, 1984) (Appendix 6) clinically significant agitation (defined as causing distress to patient and at least moderate management problems for carers on at least two days per week for a two week period, together with a Cohen Mansfield Agitation Inventory (CMAI) (Cohen-Mansfield, 1986) (Appendix 11 A) score \>39 age \>39 years resident in care facility or community living with a carer not receiving treatment with neuroleptics or cholinesterase inhibitors currently or in the past four weeks and responsible clinician not considering treatment with cholinesterase inhibitor for the next 16 weeks taking into account the clinical evidence base and NICE guideline (NICE, 2001) patient with capacity willing to consent to study or will to participate in study if lacking capacity carer with capacity willing to consent to study and in agreement for patient lacking capacity to participate if patient willing to participate
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  • Exclusion Criteria:known sensitivity to Donepezil severe, unstable or uncontrolled medical conditions apparent from history, physical examination or investigations current evidence of delirium patient meets criteria for Probably Dementia with Lewy Bodies (McKeith et al, 1996) low probability of treatment compliance
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About Institute Of Psychiatry, London

The Institute of Psychiatry, London, is a leading research institution dedicated to advancing the field of mental health through innovative clinical trials and studies. Renowned for its commitment to excellence in psychiatric research, the institute collaborates with a diverse range of academic, clinical, and industry partners to explore new therapeutic interventions and improve patient outcomes. With a focus on evidence-based practices, the Institute of Psychiatry leverages cutting-edge methodologies and interdisciplinary approaches to address complex mental health challenges, contributing significantly to the global understanding and treatment of psychiatric disorders.

Locations

Birmingham, , United Kingdom

Leicester, , United Kingdom

London, , United Kingdom

Manchester, , United Kingdom

Newcastle Upon Tyne, , United Kingdom

Oxford, , United Kingdom

Southampton, , United Kingdom

Swindon, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Robert Howard

Principal Investigator

Institute of Psychiatry, London

Peter Bentham

Principal Investigator

Queen Elizabeth Psychiatric Hospital, Birmingham

Richard Brown

Principal Investigator

Institute of Psychiatry, London

Roger Bullock

Principal Investigator

Kingshill Research Centre, Victoria Hospital, Swindon

Alistair Burns

Principal Investigator

Wythenshawe Hospital, Manchester

Clive Holmes

Principal Investigator

Moorgreen Hospital, Southampton

Robin Jacoby

Principal Investigator

Warneford Hospital, Oxford

James Lindesay

Principal Investigator

Leicester General Hospital, Leicester

John O'Brien

Principal Investigator

Newcastle General Hospital, Newcastle

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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