NCT00142324

Brief Summary

Primary Aim To determine whether;

  • Donepezil is significantly better than placebo in the management of agitation in Alzheimer's Disease that has not responded to, or is inappropriate for a standardised brief psychosocial treatment Secondary Aims To determine whether;
  • Donepezil has a significant positive or negative impact upon quality of life compared with placebo
  • whether there is a significant difference between Donepezil and placebo with respect to cognitive performance
  • the cost effectiveness of the pharmacological treatment for agitation

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2003

Typical duration for phase_4

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

December 14, 2005

Status Verified

September 1, 2005

First QC Date

September 1, 2005

Last Update Submit

December 13, 2005

Conditions

Alzheimer's Disease

Keywords

Dementia

Outcome Measures

Primary Outcomes (1)

  • Cohen Mansfield Agitation Inventory

Secondary Outcomes (4)

  • Neuropsychiatric Inventory

  • Standardized Mini-Mental State Examination

  • Severe Impairment Battery

  • Clinical Global Impression of Severity/Change

Interventions

DonepezilDRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Queen Elizabeth Psychiatric Hospital

Birmingham, B15 2QZ, United Kingdom

Location

Department of Psychiatry for the Elderly, Leicester General Hospital

Leicester, LE5 4PW, United Kingdom

Location

Institute of Psychiatry, King's College, London

London, SE5 8AF, United Kingdom

Location

Old Age Psychiatry, Wythenshawe Hospital, Manchester

Manchester, M23 9LT, United Kingdom

Location

Institute for Ageing and Health, Newcastle General Hospital, Newcastle

Newcastle upon Tyne, NE4 6BE, United Kingdom

Location

Department of Psychiatry, Warneford Hospital, Oxford

Oxford, OX3 7JX, United Kingdom

Location

MARC, Moorgreen Hospital, Southamptom

Southampton, S030 3JB, United Kingdom

Location

Department of Old Age Psychiatry, Victoria Hospital, Swindon

Swindon, SN1 4HZ, United Kingdom

Location

Related Publications (1)

  • Howard RJ, Juszczak E, Ballard CG, Bentham P, Brown RG, Bullock R, Burns AS, Holmes C, Jacoby R, Johnson T, Knapp M, Lindesay J, O'Brien JT, Wilcock G, Katona C, Jones RW, DeCesare J, Rodger M; CALM-AD Trial Group. Donepezil for the treatment of agitation in Alzheimer's disease. N Engl J Med. 2007 Oct 4;357(14):1382-92. doi: 10.1056/NEJMoa066583.

    PMID: 17914039DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Robert Howard

    Institute of Psychiatry, London

    PRINCIPAL INVESTIGATOR

  • Peter Bentham

    Queen Elizabeth Psychiatric Hospital, Birmingham

    PRINCIPAL INVESTIGATOR

  • Richard Brown

    Institute of Psychiatry, London

    PRINCIPAL INVESTIGATOR

  • Roger Bullock

    Kingshill Research Centre, Victoria Hospital, Swindon

    PRINCIPAL INVESTIGATOR

  • Alistair Burns

    Wythenshawe Hospital, Manchester

    PRINCIPAL INVESTIGATOR

  • Clive Holmes

    Moorgreen Hospital, Southampton

    PRINCIPAL INVESTIGATOR

  • Robin Jacoby

    Warneford Hospital, Oxford

    PRINCIPAL INVESTIGATOR

  • James Lindesay

    Leicester General Hospital, Leicester

    PRINCIPAL INVESTIGATOR

  • John O'Brien

    Newcastle General Hospital, Newcastle

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

November 1, 2003

Study Completion

December 1, 2005

Last Updated

December 14, 2005

Record last verified: 2005-09

Locations

GB(8)